Gilead Sciences released new findings on remdesivir showing the drug cut death rates in COVID-19 patients, but because the analysis compared data from its phase 3 study with a historical cohort of patients, health experts are not convinced.
An Italian study published in JAMA found that recovered COVID-19 patients are likely to experience symptoms of the disease long after they leave the hospital.
Plus, a team of researchers working in collaboration with Boehringer Ingelheim pinpointed 28 mutation-resistant antibodies that could help neutralize COVID-19.
The global case count had climbed past 12.3 million Friday afternoon, with more than 556,000 reported deaths, according to Johns Hopkins University's COVID-19 dashboard.
Please read below for updates. We'll chronicle the latest here. Daily COVID-19 tracker entries from Jan. 30 through April 20 can be found here.
UPDATED: Friday, July 10 at 3:30 p.m. ET
Gilead Sciences released new data Friday showing its antiviral remdesivir slashed death rates by 62% compared with standard treatment, but health experts aren't convinced. Gilead compared 312 patients dosed with remdesivir in its phase 3 SIMPLE trial against a historical cohort of 818 patients with similar disease severity on "standard of care," but because that comparison wasn't performed in a controlled trial, the numbers are "deeply flawed," one expert said. Gilead itself said the findings "[require] confirmation in prospective clinical trials."
On Friday, Tampa, Florida-based Oragenics called it quits on its candidate aimed at chemo and radiation side effects to go all-in on a COVID-19 vaccine picked up in the company's buyout of Noachis Terra. Next, the company hopes to net funding from the Biomedical Advanced Research and Development Authority (BARDA) and other federal agencies to shore up its newly-unveiled vaccine quest. Story
An Italian study of 143 recovered COVID-19 patients found that the vast majority still suffered from symptoms months later. Assessed about 60 days after their first COVID-19 symptoms arose, 87.4% of patients still reported at least one symptom related to the virus. A majority reported continued fatigue at 53.1%, with breathing difficulty a close second at 43.4%. The results, published in the medical journal JAMA, make a case for continued monitoring of COVID-19 patients post-hospital discharge.
Britain's decision to opt out of an E.U. effort to score vaccine doses—reported yesterday via The Telegraph—will not affect ongoing talks with drugmakers, the European Commission said Friday. In June, Reuters reported that European officials were hashing out deals with Johnson & Johnson and Sanofi to lock down doses of their COVID-19 vaccine candidates.
Medtech company Philips will fold BioIntelliSense’s health-tracking sticker into its remote patient monitoring programs to observe COVID-19 patients—and those hit with other chronic diseases—after they leave the hospital. U.S. service provider Healthcare Highways will be the first to use the BioSticker across seven monitoring programs, which include COVID-19. Story
Boehringer Ingelheim's collaboration with academic researchers to develop COVID-19 treatments has paid off with the discovery of 28 antibodies that could neutralize the virus. A research team headed by Cologne University Hospital and the German Center for Infection Research compared the antibody response to COVID-19 in 12 patients who recovered from the virus to immune cells from 48 healthy people collected before the pandemic, ID'ing antibodies with the strongest neutralizing effect. The research teams predict clinical trials on the top antibody candidates could start by year's end. Story
UPDATED: Friday, July 10 at 9:18 a.m. ET
An FDA green light for Pfizer's mRNA vaccine candidate—developed by German partner BioNTech—could come as early as October, CEO Albert Bourla told TIME. On the heels of positive phase 1/2 results, Pfizer ramped up its projected shot production to 100 million doses by year's end. The company has also launched talks with governments around the globe to mete out supplies, Bourla said. A phase 3 vaccine trial enrolling 30,000 patients is expected to begin later this month.
Meanwhile, BioNTech expects to seek regulatory approval for the messenger RNA shot by the end of the year, CEO Ugur Sahin told the Wall Street Journal. The German biotech expects the upcoming phase 3 study to conclude by late 2020 and regulatory fillings to follow immediately. Sahin stood by the company's goal to churn out hundreds of millions of doses pre-approval, with that number expected to land in the billions by 2021. Story
COVID-19 patients dosed early on with Fujifilm's flu med Avigan in a Japanese clinical trial showed more improvement than those treated after their illness advanced, but the results weren't statistically meaningful, researchers from Fujita Health University said Friday. The drug, known generically as favipiravir, has already been approved for COVID-19 in Russia and India, but Japan has struggled to keep its own studies on track as the country faces a shortage of trial participants.
The World Health Organization backtracked its assertion that the coronavirus doesn't spread through small, airborne particles. In a letter published this week, two scientists from Australia and the U.S. argued that the virus is released "in microdroplets small enough to remain aloft in the air," and more than 200 experts urged WHO to update its guidance on virus transmission. Now, WHO has conceded that airborne spread, especially in indoor spaces, "cannot be ruled out."
Researchers at Regeneron's Tarrytown, New York headquarters dove into COVID-19 antibody work when the virus first struck in January. Then, in March, the virus touched down on the company's home turf. The drugmaker quickly adjusted, pushing its other projects to a plant in Ireland, staggering shifts and repurposing company cars for staffer commutes. The payoff? Regeneron's much-hyped antibody cocktail now moving into treatment and prevention trials.
Plus, Novo Nordisk forged ahead with the early 2020 launch of its diabetes med Rybelsus when the outbreak struck. Noting the increased risk for COVID-19 complications in patients with uncontrolled diabetes, Novo paired coronavirus education with its launch strategy. Meanwhile, Novo beefed up its digital presence by holding a virtual speaker series for doctors and launching an online copay system where patients could also ask Rybelsus questions via text.
UPDATED: Thursday, July 9 at 3:20 p.m. ET
FDA vaccine official Peter Marks thinks eradicating SARS-CoV-2 will take a vaccine that's 70% effective—and received by 70% of the population. Marks' guidance eclipses the FDA's 50% efficacy bar it set last week. In order to make sure the vaccine is truly effective, the FDA is strongly encouraging companies to recruit a diverse group of trial participants, Marks said. He also added that "challenge trials"—in which patients are infected with the virus to accelerate research—weren't completely off the table; the agency would consider such trials "based on protocol" and "given the circumstances," Marks said. Story
Meanwhile, officials from Merck, Moderna, Pfizer, AstraZeneca and Johnson & Johnson plan to testify before the House's Oversight and Investigation Subcommittee on July 21 to discuss their progress on a COVID-19 vaccine. The companies are also expected to share info on upcoming plans to market and distribute those shots should they pass muster in the clinic.
The University of Oxford and its Oxford Suzhou Centre for Advanced Research in China are launching a new company, dubbed Oxsed Limited, to develop a rapid COVID-19 test with an expected price of no more than £20 ($25). The simplified viral RNA test uses RT-LAMP technology, which requires far less hardware and labor to yield a result than widely-used PCR-based lab tests, making it more desirable for use in the field. Next up, Oxsed Limited will pursue a CE mark as it looks to push the test to market. Story
Plus, the Center for Health Security at Johns Hopkins Bloomberg School of Public Health issued a report Thursday outlining the public's role in COVID-19 vaccination efforts. The center highlighted common anxieties among the public about vaccination safety, affordability and access, along with suggestions on how companies might ease those concerns. Offering vaccines at no cost to all U.S. residents, establishing safe and familiar vaccination sites and forming official communication channels to counter misinformation and increase public ownership over vaccine programs were among the center's chief recommendations.
UPDATED: Thursday, July 9 at 9:15 a.m. ET
Moderna tapped contract manufacturer Laboratorios Farmacéuticos Rovi to complete fill-finish work on its mRNA vaccine candidate. Rovi will carry out the work at its Madrid, Spain, facility, and plans to ramp up a new production line and buy new equipment to help Moderna meet its goal to churn out hundreds of millions of shot doses for deployment outside of the U.S. by early 2021. Rovi will also recruit additional staff to meet the new manufacturing demand. Story
Plus, Johnson & Johnson CEO Alex Gorsky warned that an approved COVID-19 vaccine would not be a pandemic panacea. Even if multiple candidates are approved by early 2021, proper education and distribution systems will determine whether that shot is deployed successfully. Social distancing, mask-wearing and drug development will remain essential even after a shot is available, Gorsky warned.
The Centers for Disease Control and Prevention (CDC) and an advisory committee of health experts are patching together a plan for how—and to whom—an eventual COVID shot should be allocated. Under the preliminary plan, medical and national security experts would get first dibs, followed by front-line workers and those at higher risk of infection like the elderly and immunocompromised. Now, the group is weighing whether to provide early access to Black and Latino populations, who've suffered disproportionately from the virus.
Gilead Sciences dosed the first patients in a phase 1a trial studying an inhaled formulation of remdesivir for early stage COVID-19. The drugmaker aims to recruit about 60 U.S. patients aged 18 to 45 for the trial, which will compare a nebulized version with placebo. Delivering remdesivir straight to the lungs could cut the risk of side effects and expand its use to outpatients, Gilead said; remdesivir is currently given to hospital patients intravenously. Story
Plus, Gilead plans to boost worldwide production of remdesivir to supply the antiviral in Europe based on each country's rate of infection, the company's German managing director Bettina Bauer said. Talks are already underway with the German government, Bauer told German business magazine WirtschaftsWoche. The drugmaker aims to ramp up its monthly supply from 190,000 treatment cycles to 2 million by December, she said.
Russia OK'd a new COVID-19 antiviral from drugmaker R-Pharm, dubbed Coronavir, after positive performance in a trial of more than 110 outpatients with mid-stage COVID-19. By the fifth day of treatment, the virus had been eliminated in 77.5% of Coronavir patients, R-Pharm said. It's the third drug approved in Russia to treat COVID-19.
UPDATED: Wednesday, July 8 at 3:20 p.m. ET
The Coalition for Epidemic Preparedness Innovations (CEPI) expanded an earlier deal with China-based Clover Biopharmaceuticals in a bid to hustle Clover's S-Trimer COVID-19 vaccine candidate into clinical testing. In April, CEPI invested $3.5 million to help Clover prep for phase 1, and now it will shell out $66 million more to speed Clover's shot into preclinical and phase 1 studies, and help the company scale up manufacturing.
Lyon, France-based biotech Osivax snapped up €30 million ($33.8 million) from the European Innovation Council (EIC) and Bpifrance to develop its universal coronavirus and influenza vaccines. Osivax's flu shot is designed to help the immune system recognize a conserved part of the influenza virus, rather than its mutation-prone surface antigens, and the company is pivoting that same tech to target SARS-CoV-2—the virus behind the current COVID-19 pandemic—plus future coronavirus strains. Story
Amgen could pit Enbrel—or another drug from its anti-TNF portfolio—against COVID-19, CEO Robert Bradway hinted during Fortune's Brainstorm Health virtual conference. Other anti-inflammatories like Roche's Actemra and Novartis' Ilaris are already in clinical trials to curb potentially fatal immune reactions in COVID patients; meanwhile, Regeneron and Sanofi axed a trial studying their IL-6 inhibitor Kevzara in ventilated COVID patients earlier this week. Amgen has also ramped up trials for its psoriasis drug Otezla to prevent respiratory distress in COVID patients. Story
Indian drugmaker Cipla has deployed its version of remdesivir in the country, setting the sticker price at INR 4,000 per 100mg vial, or about $53.38—one of the lowest prices globally. For comparison, Mylan has capped its generic form of the drug at INR 4,800 ($64.05) per 100mg vial, while Hetero set a maximum retail price of INR 5,400 ($72.06). Cipla aims to dispense 80,000 vials in the first month, and will make them available through government and hospital channels, CEO Nikhil Chopra said.
The National Institute of Allergy and Infectious Diseases (NIAID) started a new clinical trials network, aiming to enroll thousands of volunteers in large-scale, phase 3 studies of COVID-19 vaccines and antibody treatments. The new COVID-19 Prevention Trials Network (COVPN) is expected to conduct its first phase 3 trial on Moderna's mRNA vaccine candidate, which could start as early as this summer, the NIH said. Story
Medical device maker BD scored an emergency OK from the FDA for a portable coronavirus antigen test designed to turn out results in about 15 minutes. In clinical studies, the diagnostic correctly ID'd 84% of positive COVID-19 samples and yielded no false negatives. BD aims to produce 10 million coronavirus tests through September, with 2 million per week after that. Story
With a recent cash infusion from BARDA and the U.S. Department of Defense—and amid worries about shortages of glass vials for COVID-19 treatments and vaccines—drug packaging company SiO2 Materials Science will invest $163 million to upgrade its Auburn, Alabama, vial plant. Story
An FDA report found that at least 87 people died from taking hydroxychloroquine and chloroquine between December and May 6. The agency pored over 380 hydroxychloroquine safety reports as part of its review, 28% of them from the U.S. Earlier this week, President Donald Trump touted the drug for COVID-19—again—despite the FDA's decision to pull its emergency authorization.
Plus, Brazilian President Jair Bolsonaro, who confirmed yesterday that he had tested positive for COVID-19, said he was taking hydroxychloroquine, adding that the once-hyped antimalarial made him feel "a lot better." Bolsonaro has faced criticism for downplaying the severity of the virus as it rages across Brazil, second only to the U.S. in COVID-19 deaths.
UPDATED: Wednesday, July 8 at 9:00 a.m. ET
The European Commission inked deals with Roche and German drugmaker Merck KGaA to secure doses of those companies' experimental COVID-19 treatments for any of the 27 E.U. nations willing to buy, Reuters reported. Roche will supply its arthritis med Actemra, also known as RoActemra, while Merck is offering up its multiple sclerosis med Rebif. Both drugs have anti-inflammatory properties and may help curb cytokine storm in severely ill COVID patients.
Meanwhile, Actemra and remdesivir have hit the black market in Delhi, with exorbitant price tags to match, a BBC investigation found. Patients searching for remdesivir, which Indian doctors can prescribe on compassionate grounds, report that the drug is almost impossible to find in pharmacies. So far, Hetero is the only Indian firm producing Gilead's antiviral in the country. Meanwhile, Cipla, which sells Actemra in India, pointed to supply difficulties surrounding that import-only drug.
And Cipla announced that its version of remdesivir is slated to hit Indian markets in the next few days. Cipla partnered with Mumbai-based BDR Pharma to manufacture the drug, which in turn sub-contracted Sovereign Pharma to complete fill-finish work. The partners haven't said how much they plan to ship, but Sovereign said it can scale up to 95,000 vials per month.
Bristol Myers Squibb CEO Giovanni Caforio and Novartis chief Vas Narasimhan touted industry collaboration amid the pandemic at Fortune's virtual Brainstorm Health Conference. Open sharing of research, access to pharma companies' drug formulas and regular R&D chief meetings have helped the industry pivot to tackle the virus as a team, the CEOs said. Eyeing the next possible pandemic, Narasimhan advocated for global surveillance of hotspots where known viruses can infect humans. Meanwhile, Caforio thinks this newfound industry collaboration could tackle other diseases like cancer.
Medical experts condemned the "desperation science" that they say has colored COVID-19 treatment and vaccine research. Faced with a pandemic, many researchers have cut corners, making traditional clinical research look slow, and the public has undermined some legitimate R&D by getting its hands on unproven treatments like hydroyxychloroquine. “Everyone has been kind of grasping for anything that might work. And that’s not how you develop sound medical practice,” said frequent FDA adviser Dr. Steven Nissen. "Desperation is not a strategy."
And even as the Trump Administration has vowed to crack drown on price surges during the pandemic, pharmaceutical companies logged more than 800 drug price increases this year, data from GoodRx found. In July alone, companies hiked the price of 42 meds by an average of 3.3%. Non-COVID related respiratory treatments Bevespi Aerosphere, Daliresp and Tyvaso are among those with boosted prices, and AstraZeneca raised the cost of its heartburn drug Nexium by 6%. Critics have blasted the industry for sticking to its "price-hiking playbook" amid the pandemic.
The Marriott Long Wharf hotel, which in late February hosted the now-infamous Biogen leadership conference that resulted in at least 100 known COVID-19 infections in Massachusetts, reopened Tuesday.
UPDATED: Tuesday, July 7 at 3:10 p.m. ET
Johnson & Johnson has updated its pact with New Jersey-based Catalent for undisclosed finishing work at the CDMO's Anagni, Italy, facility. Catalent was recently tapped by British drugmaker AstraZeneca for fill-finish work on its Oxford-partnered COVID-19 vaccine at that same plant, and in April, Catalent signed an initial deal with J&J to reserve fill-finish capacity for its COVID-19 shot at the CDMO's Bloomington, Indiana, site. Story
Moderna's shares dropped 5% last week when news surfaced that it might delay the launch of its phase 3 vaccine trial due to protocol changes. Now, some of those potential hiccups have come to light: Moderna sparred with government experts over how to run its trial, sought a lower bar for approval than the 50% efficacy rate outlined by the FDA, and submitted trial protocols late, three sources close to the vaccine project told Reuters. Moderna has dismissed the snags as "differences of opinion." Story
GlaxoSmithKline added Medicago to it's growing list of COVID vaccine partners as it looks to combine its pandemic adjuvant system with Medicago's recombinant coronavirus virus-like particles (CoVLP). CoVLPs mimic the virus' structure, allowing them to be ID'd by the immune system; pairing that approach with an adjuvant "may boost the immune response and reduce the amount of antigen required per dose," GSK said. A phase 1 study is expected to launch in the next week or so, and the partners said they aim to make the vaccine available by the first half of 2021. Story
Testing giant LabCorp launched a new, at-home COVID-19 test collection service to help doctors screen patients for the disease before surgeries and treatments. The service will allow doctors to order at-home tests for patients through LabCorp, which patients will FedEx back to the company. LabCorp will then upload patients' results to their healthcare providers' electronic medical records. The service scored an emergency OK from the FDA on July 1 and will launch with select providers before a broader rollout in hospitals and surgical centers, LabCorp said.
German vaccine maker CureVac nabbed a nearly $85 million loan from the EU to scale up manufacturing at its Tübingen, Germany, facility for its mRNA-based COVID shot. The loan, financed by the European Investment Bank, is set to pay out in three $28.3 million increments upon CureVac's completion of preset milestones, the company said. CureVac will use the extra funds to upgrade its current mRNA production suites and build a fourth facility at the Tübingen site. Story
The Serum Institute of India aims to develop a COVID-19 vaccine by the year's end, CEO Adar Poonawalla said during the launch of a compact diagnostics machine by MyLab Discovery Solutions. The Serum Institute has also invested over 1 billion Indian Rupees ($13.4 million) in the Pune-based molecular diagnostics firm in a bid to increase Indian testing capacity. Poonawalla added that the Serum Institute would take its time to produce a vaccine, with more news on that front expected about six months from now.
Public perception of the industry has improved during the pandemic, and a new study from Novartis showed that 73% of tech professionals have warmed up to pharma as it responds to COVID-19, too—well above the general public's 40% rise in opinion found by the Harris Poll. Now, Novartis chief digital officer Bertrand Bodson thinks that shift could attract sought-after tech talent to pharmaceutical companies and expand tech training options for current staffers. Story
President of Brazil Jair Bolsonaro, who has repeatedly taken flak for downplaying the severity of the virus that has infected more than 1.6 million in the country and killed over 65,000 Brazilians, confirmed Tuesday that he had tested positive for COVID-19. The president said that the took a coronavirus test Monday after he was hit with fever and fatigue, but added that he was feeling well, which he attributed to having taken hydroxychloroquine—a drug that has shown no benefit in trials.
Meanwhile, president Donald Trump took to Twitter to voice support—again—for failed COVID-19 treatment hydroxychloroquine Monday. White House adviser Peter Navarro doubled down Tuesday morning, telling CNN, "Give peace a chance and give hydroxy a chance, it can save lives." In mid-June, the FDA axed its emergency use authorization for the drug in COVID-19 patients, followed by a warning on July 1 that use of the drug outside hospitals and clinical trials could pose serious health risks.
UPDATED: Tuesday, July 7 at 9:09 a.m. ET
Beijing-based Sinovac Biotech scored approval from Brazil's regulatory agency, Anvisa, to launch a phase 3 trial of its inactivated COVID-19 vaccine in the country. Anvisa fast-tracked the application for the trial, which will run in partnership with Brazilian vaccine maker the Instituto Butantan and aims to recruit nearly 9,000 healthcare workers from COVID-19 specialized facilities. Enrollment is slated to start this month.
Plus, Novavax was selected for the Trump Administration's Operation Warp Speed after all. The company said Tuesday that it had scored $1.6 billion from the program to rapidly scale up production and launch late-stage human studies of its COVID-19 vaccine candidate, which uses an antigen generated from the virus' spike protein plus Novavax's Matrix-M adjuvant. Novavax now plans to launch phase 3 trials on up to 30,000 patients starting in the fall and pledges to deliver 100 million doses of its shot as early as the end of the year should it succeed in the clinic. Story
Regeneron inked a $450 million manufacturing and supply contract with the Biomedical Advanced Research and Development Authority (BARDA) and the U.S. Department of Defense to churn out doses of its COVID-19 antibody cocktail, REGN-COV2. The funding comes as part of the Operation Warp Speed program to accelerate development of coronavirus treatments and vaccines. Yesterday, the company said it would move its antibody duo into the next phase of human studies and launched an additional phase 3 prevention trial. Story
E.U. Health Commissioner Stella Kyriakides, along with other health officials, held talks with Gilead Sciences Monday to hash out remdesivir supplies for 16 European countries, including Germany, Belgium, and the Netherlands, an unnamed source close to the talks said. The European Commission confirmed that talks were taking place at a technical level, but provided no further detail. The move comes as governments and health experts blasted the U.S. for buying much of Gilead's remdesivir supply through September. Story
UPDATED: Monday, July 6 at 3:12 p.m. ET
Johnson & Johnson inked a five-year work order with Maryland-based CDMO Emergent BioSolutions—worth an initial $480 million—to help churn out doses of its COVID-19 vaccine candidate. Emergent will provide "large scale" drug substance manufacturing for two years starting in 2021; for the final three years, the partners will adjust to supply annual batches as needed. Back in June, Emergent penned an $87 million deal with AstraZeneca to help the British drugmaker turn out more than 2 billion doses per year of its Oxford-partnered shot by 2021. Story
Plus, Warp Speed finalist Moderna took a 5% hit to its shares last Thursday after an anonymous investigator told healthcare publication Stat that the company would delay starting its phase 3 vaccine trial. Moderna quickly took to Twitter to maintain that its mRNA vaccine hopeful was still on track to start testing this month. Story
Sanofi and Regeneron nixed U.S. studies of rheumatoid arthritis med Kevzara in ventilated COVID-19 patients after the drug failed to slash death rates or move patients off ventilators in a phase 3 trial. On top of that, 80% of patients given the 400mg dose of Kevzara showed side effects compared with 77% in the standard-of-care control group, and 3% suffered severe side effects like multi-organ dysfunction and low blood pressure. A Kevzara study outside the U.S. will barrel ahead nonetheless. Story
Indian drugmaker Zydus Cadila said it got the thumbs up to run phase 2b trials on its investigational drug desidustat—previously pitted against anemia and kidney disease—in COVID-19 patients in Mexico. Working with one of Mexico's leading contract research organizations, the Avant Santé Research Center, Zydus will dose patients with 100mg tablets of desidustat over a 14-day period in hopes that the drug will treat signs of hypoxia that lead to organ failure and death in COVID patients.
And with flu season looming as COVID-19 rages on in the U.S., the FDA issued an emergency OK to the CDC for a combination influenza/COVID-19 diagnostic test. The CDC's new multiplexed assay will distinguish between patients with one of the two diseases, who may present similar symptoms, in a move that aims to expedite American testing results and ease the strain on diagnostic supplies, FDA commissioner Stephen Hahn said. Story
And 239 scientists in 32 countries are calling on the World Health Organization to update its guidance on the virus' spread. An open letter to the agency—slated for publication next week—argues the coronavirus can spread through small, airborne particles, not just droplets, the New York Times reported. The WHO has pushed back, stating that airborne transmission is "possible but certainly not supported by solid or even clear evidence."
Digital outreach has become the new norm for pharmaceutical companies in China, top execs from WPP Health told Fierce Pharma, and the benefits of those virtual tools could have a huge impact on healthcare providers and patients long after the pandemic subsides. Beyond the industry, patient access in China—a longtime dilemma for country's huge population—has improved with the novel use of messenger apps like WeChat, WPP Health's executive vice president of market access Yi Han said. Story
UPDATED: Monday, July 6 at 9:00 a.m. ET
Regeneron's dual antibody cocktail REGN-COV2 will move into phase 2/3 trials to both treat and prevent COVID-19. Slated to take place at around 100 sites, the phase 3 prevention trial will test the cocktail against infection rates in an expected 2,000 U.S. patients. Phase 2 treatment trials will focus on hospitalized and non-hospitalized patients in the U.S., Brazil, Mexico and Chile. Preliminary data are expected over the summer, Regeneron said. Story
In the wake of a similar agreement with AstraZeneca and Oxford University, the U.K. government is closing in on a £500 million ($625 million) deal with Sanofi and GlaxoSmithKline to secure 60 million doses of the partners' coronavirus vaccine candidate, sources near the deal told The Sunday Times. Human trials on the GSK-Sanofi shot aren't expected to start before September, but the U.K., heavily reliant on vaccine imports, has worked to lock down supplies ahead of a COVID shot approval. Story
Mylan won approval from India's drug regulator for restricted use of its licensed version of remdesivir in hospitalized children and adults with severe COVID-19 symptoms. The drug's price will be INR 4,800 ($64.31), about 80% less than the sticker price Gilead Sciences unveiled last week; Mylan's license is for lower-cost versions of remdesivir in developing countries.
The European Commission granted a conditional OK for Gilead's remdesivir to treat COVID-19 patients 12 years and older with pneumonia requiring oxygen support. The conditional approval is good for one year, but the commission may extend it if the drug shows promise in trials testing it in younger patients and in earlier stages of the disease.
Taking a cue from interim trial results that showed the drugs did little to lower death rates, the WHO axed trial arms studying the discredited drug hydroxychloroquine and the HIV med Kaletra—sold by AbbVie—in hospitalized COVID-19 patients. Current studies of the drugs in non-hospitalized patients won't be affected, the agency said.
FDA commissioner Stephen Hahn refused to make a prediction about the current vaccine timeline Sunday, on the heels of a Fourth of July address in which President Donald Trump claimed that unleashed U.S. "scientific brilliance" would see a shot delivered well before year's end. The FDA will weigh safety and efficacy in deciding whether to approve a given shot, Hahn told ABC. Agency officials last week said vaccines must prove at least 50% effective to win final approval.
Former FDA chief Scott Gottlieb urged the U.S. to build up reserves of antibody treatments as promising candidates from AstraZeneca, Eli Lilly, Regeneron and more approach approval to treat COVID-19. "The government should be working with companies ahead of time," Gottlieb told CBS, adding, "We missed the window to do it on remdesivir."
Meanwhile, the U.S. is sending stores of recently stockpiled remdesivir to hard-hit states like Arizona, Texas and Florida, where new COVID-19 cases have surged, Hahn said. The U.S. faced criticism last week for snapping up 90% of Gilead's remdesivir supply for August and September.
Plus, AstraZeneca staffers were struggling to balance home-life with at-home work during lockdown. The British drugmaker's solution? Recruit more than 80 teachers to run online classes for employees' children.
UPDATED: Thursday, July 2 at 9:00 a.m. ET
Officials and health experts around the world lambasted the U.S.' move to snap up most of Gilead Sciences' remdesivir supply. The company says it's working up new doses "as quickly as possible" but noted that the U.S. is seeing a surge of cases, while the spread has moderated elsewhere. The U.K. and Germany told Reuters they have enough on hand for now. Still, the EU wants its own supply, and officials there said they're in talks with Gilead Sciences to arrange just that.
Tesla is building mobile molecular printers to help make an mRNA vaccine in development at CureVac. The machines—which Tesla CEO Elon Musk called "RNA microfactories"—would ship to remote locations and produce CureVac's coronavirus vaccine on-site. For now, though, CureVac has approved manufacturing facilities in Germany where it can turn out hundreds of millions of doses.
Quest and LabCorp are warning that skyrocketing demand for COVID-19 tests is straining their capacity. Quest can perform about 770,000 tests per week, but orders grew by about 50% over the past three weeks, and turnaround time is now 3 to 5 days for patients outside hospitals. It's ramping up to 150,000 tests a day, the company told ABC News. Meanwhile, LabCorp said its turnaround time is delayed even as it expands capacity as quickly as possible.
As the U.S. passed 50,000 daily cases for the first time Wednesday, former FDA chief Scott Gottlieb, M.D., warned the true number is likely 400,000 to 500,000—and the U.S. just doesn't have the testing capacity to identify all of them. "[P]robably 200,000-300,000 are symptomatic," Gottlieb told CNBC. Gottlieb's remarks follow a warning from National Institute of Allergy and Infectious Diseases Director Anthony Fauci, M.D., that daily case counts could hit 100,000. "[W]e're well more than 100,000 cases a day right now," Gottlieb said.
Eusa Pharma, which usually focuses on rare diseases and cancer, won FDA approval to run a phase 3 trial testing its drug Sylvant against COVID-19. The trial would add Sylvant (siltuximab) to standard of care in hospitalized patients in respiratory distress. It's not Sylvant's only coronavirus foray, but this 400-patient trial is "vital," the company said, because well-controlled data are currently lacking. Sylvant is one of several IL-6 inhibitors tackling the potentially deadly lung inflammation that hits severely ill COVID-19 patients.
Another study suggested that HIV drugs—specifically AbbVie's combo med Kaletra—aren't likely to be useful for COVID-19 patients. This time, researchers did a deep dive into existing studies, so the results aren't as persuasive as a clinical trial would be. But their conclusions match up with Recovery trial data reported in the U.K. earlier this week.
UPDATED: Wednesday, July 1 at 3:30 p.m. ET
One of Pfizer and BioNTech's four mRNA vaccine candidates successfully boosted antibody levels in COVID-19 patients, early phase 1/2 data show. In the 45-patient trial, participants dosed with 10 mcg and 30 mcg of the shot generated antibody levels 1.8 and 2.8 times higher, respectively, than the average in a group of patients with confirmed infections. With four vaccine hopefuls in the can, Pfizer and BioNTech are reviewing shot data as they gear up for phase 3 trials that could begin as early as this month. Story
Despite the FDA's Monday guidance that a COVID-19 vaccine would need to prove 50% effective for approval, the means to secure emergency use authorization (EUA) "remain vague," analytics firm GlobalData says. Other analysts have warned political pressure could drive those decisions, even as the agency makes a bid for transparency. And in parsing Monday's guidance, Jefferies analyst Michael Yee said an EUA is the "likely scenario" for early vaccine rollout. Story
Researchers from Columbia University and the University of Wisconsin-Madison pinpointed five FDA-approved antivirals with COVID-19-fighting potential. Those drugs, which come from Roche, Gilead Sciences, Bristol Myers Squibb and more, can shut down the polymerase protein reaction that drives growth and spread of the virus in the body. Next, the researchers will conduct cell-culture studies to determine the most potent of the five for further testing. Story
Nearly 200 companies have stalled or stopped clinical trials during the pandemic, and suspended enrollment is largely to blame, GlobalData found, citing a whopping 67.3% of trials disrupted for that reason. The analytics firm said that the majority of disrupted trials were in phase 2, with cancer studies hit especially hard. Story
Synthetic DNA maker Twist Bioscience launched a new research panel to identify respiratory diseases, including the novel coronavirus, using next-generation sequencing that can also detect rhinoviruses, flu strains and more. While not a COVID diagnostic itself, the research panel could catch early signs of outbreak, transmission and viral evolution, Twist CEO Emily Leproust, Ph.D., said. Story
Meanwhile, LabCorp's contract research organization Covance revamped its Xcellerate platform to help get disrupted trials back on track. Designed in partnership with Covance's COVID-19 Operational Recovery Team, the platform will use real-time data and analytics to identify disruptions as they happen, such as large numbers of patients dropping out of a trial, so that Covance can attempt to right the course. Story
UPDATED: Wednesday, July 1 at 9:30 a.m. ET
Japan's Fujifilm Holdings forged a deal with Indian pharma Dr. Reddy's Laboratories and Dubai-based Global Response Aid to sell its flu med Avigan for COVID-19 treatment in countries worldwide, excluding China, Russia and Japan. Dr. Reddy's also signed on to run clinical trials of the med in India. Meanwhile, Japan has touted Avigan's potential against the virus, but shortfalls in trial enrollment there have slowed its journey to approval. Story
The China National Biotec Group—an arm of the country's state-owned Sinopharm—on Wednesday finished construction of a new coronavirus vaccine plant in Wuhan, doubling that site's capacity to more than 200 million doses a year. The extra manufacturing brawn will aid Sinopharm as it preps its dual COVID shot candidates to enter large-scale phase 3 trials in the United Arab Emirates later this year.
In a move condemned for putting "America first" amid the pandemic, the U.S. has reportedly bought out Gilead Sciences' entire remdesivir supply for July, and the lion's share for the next two months, too. The initial 140,000 doses Gilead provided for global COVID-19 trials are tapped out, the drugmaker said. Now, the Trump administration has called dibs on the its next 500,000 doses, shutting out other countries for at least the next three months.
Plus, Novartis CEO Vas Narasimhan sat down with Wired to talk vaccines, pricing and drug launches during a pandemic. Among Narasimhan's pearls of wisdom? Big Pharmas will continue to rely on digital tools as the industry relearns business-as-usual in the era of social distancing. Meanwhile, Narasimhan also touted the importance of cutting drug hype with solid clinical evidence—especially as politicians make sweeping claims about certain drugs' benefits—and said the U.S. would need to campaign against vaccine doubt ahead of a final shot.
And while the FDA has approved more than 30 new medicines since January, drugmakers Bristol Myers Squibb, Sanofi, Endo Pharmaceuticals and more have had to change their launch plans in response to the pandemic, with additional delays on the horizon, Reuters reports. Companies' top lines could take a hit from those delayed launches, but more worrisome are the patients left without treatment options for less-acute diseases; a peanut allergy med from Aimmune and Neurocrine's Parkinson's drug Ongentys are among those delayed.
At the start of the pandemic, GlobalData noted sales bumps for some drugmakers in the year's first quarter as people stockpiled medications. Now, the firm has released updated figures showing pharma companies with COVID-19 treatments in their pipelines only grew sales by 3% in the first quarter, compared with 8% growth among pharmas with more diverse drug offerings. Companies pinning their hopes on a single COVID-19 treatment going to market are taking a big gamble, a GlobalData analyst warned.
UPDATED: Tuesday, June 30 at 4:00 p.m. ET
Gene and cell therapies are are branching out into the world of viruses, and biopharmas like Celularity and AlloVir have pivoted to tackle COVID-19, too. Celularity has managed to turn cancer-fighting natural killer cells against the novel coronavirus, while AlloVir is looking to use its off-the-shelf T cell treatments against the disease. But those companies will have a long road ahead of them to prove their products are at least as safe as more common treatments, like antivirals—and worth the extra cost. Story
Citing huge inconsistencies in reported COVID-19 data, MIT researchers put together their own epidemiological model to trace the virus' spread. Armed with case counts, death tolls and other data from 84 countries, the researchers pegged the true global case count at around 88.5 million, or 11.8 times the official tally, with an estimated 600,000 deaths. Now, the research team says the time for preventative testing has passed: The virus' future spread will depend on government and community willingness to do what it takes to halt transmission.
Plus, MIT Press will launch a new journal that reviews early versions of coronavirus-related studies known as preprints. The move comes as concerns mount over the large volume of data going public without peer review. The journal will rely on artificial intelligence developed at Lawrence Berkeley National Laboratory to categorize preprints by discipline and novelty, and an in-person team of around 100 will scan those most in need of review. The first set are slated for publication in mid-July.
At a Senate hearing Tuesday, NIAID director Anthony Fauci warned that daily U.S. coronavirus infections could top 100,000 if current outbreaks aren't curbed. Meanwhile, Fauci joined CDC director Robert Redfield in urging officials to help debunk vaccine skepticism ahead of a successful shot—and the looming school year. The CDC has spent the past three months building a plan to boost "vaccine confidence," Redfield said.
A lowly 2% of U.S. patients are currently taking dexamethasone for COVID-19 despite that drug's recent buzz, data analysis firm CarePort Health told Fierce Pharma. Some other highlights from CarePort's usage analysis? Use of remdesivir stalled at 1% to 2% of coronavirus patients from May until late June, when the drug saw a 15% spike, and hydroxychloroquine use plunged to 1% in early June, well before the FDA axed its emergency authorization. The antibiotic azithromycin peaked at 50% in March before dropping to its current 28%.
UPDATED: Tuesday, June 30 at 9:30 a.m. ET
AbbVie's HIV treatment Kaletra, failed to help patients hospitalized with COVID-19, the U.K.'s Recovery Trial found. Among 1,596 patients dosed with Kaletra—a combination of the antivirals lopinavir and ritonavir—22.1% died, compared with 21.3% of patients in the control group. Plus, the drug had no effect on disease progression or length of hospital stay. The stats dispel hopes for Kaletra's use in coronavirus patients, the trial investigators said, and they shut down enrollment in that arm of their study.
Inovio turned in strong interim data from a phase 1 test of its DNA-based vaccine, now tapped to take part in Operation Warp Speed challenge trials, the company said. Forty healthy adults each received two doses two weeks apart. By week six, 34 out of 36 patients—around 94%—had generated an immune response with minimal side effects, Inovio said, and four dropped out. The company aims to launch phase 2/3 trials in older adults this summer.
The FDA plans to offer strict guidance on COVID vaccine hopefuls Tuesday. To win approval, a vaccine will need to prove 50% more effective than a placebo, and its safety must be confirmed in clinical trials, the FDA said. Post-marketing studies will be required for approved vaccines, and patients should be monitored for a year after dosing.
Hyderabad-based Bharat Biotech said Monday that it had developed India's first COVID-19 vaccine candidate, Covaxin, and won approval from the country's drug regulator to start phase 1/2 trials in July. Bharat, which previously developed a successful flu shot, created the coronavirus prospect in partnership with the Indian Council of Medical Research and the National Institute of Virology.
Mexico is in talks with the Chinese government, private Chinese labs, and the University of Oxford and AstraZeneca to run COVID-19 vaccine trials in the country, a government official told Reuters.
Plus, hydroxychloroquine could make a comeback as the U.K.'s Medicines and Healthcare Products Regulatory Agency gave its blessing to restart trials on the drug in Bangkok. The study, dubbed COPCOV, aims to enroll 40,000 healthcare workers and other at-risk staffers, led by Oxford University’s Mahidol Oxford Tropical Medicine Research Unit.
And NIAID director Anthony Fauci plans to testify before Congress Tuesday for the second time in two weeks. At a tense hearing before House lawmakers last week, the FDA broke with the White House's pandemic advice and Fauci warned of troubling resurgences across the country. Today, Fauci will again join top officials from the CDC and FDA in a bid to address the latest spikes in at least 30 states.
UPDATED: Monday, June 29 at 3:35 p.m. ET
The wait for remdesivir pricing is over as CEO Daniel O'Day revealed Monday that Gilead Sciences had set a list price of $520 per vial, or $3,120 for the five-day, six-vial course most patients are expected to receive. That falls well below the $5,000 price tag some Wall Street analysts had rooted for, but drug cost watchdog the Institute for Clinical and Economic Review called the final price responsible. And even at the $2,340 government purchase price, Gilead could still nab around $2.3 billion in 2020 sales of the antiviral, one analyst said. Story
A plasma-based treatment could beat a COVID vaccine to market, or so says the R&D chief of Takeda's plasma therapies unit, Chris Morabito. The Japanese drugmaker has joined CSL Behring and a suite of plasma specialists to develop a hyperimmune globulin—made by purifying plasma from recovered patients—that gives patients multiple antibodies to fight the virus. Takeda will work with the group to deliver a single, unbranded medicine, potentially by year's end, Morabito said. Story
Beckman Coulter scored an emergency approval from the FDA to deliver more than 30 million coronavirus antibody tests per month worldwide, with shipping already underway at more than 400 U.S. hospitals, clinics and labs, the company said. The mass-produced test can run on a variety of manufacturers' machines, plus the company's own Access 2 tabletop device. Story
Contract research organization PPD has developed five new molecular, serology and functional assays to boost ongoing COVID-19 lab test work. That's in addition to the 15 FDA-approved vaccine programs PPD Labs has supported, plus a program launched in March through its Accelerated Enrollment Solutions unit to relocate clinical trial patients from COVID-hit facilities to PPD research sites. Story
In a conversation with Oppenheimer, former president of MD Anderson Cancer Center Ron DePinho, M.D., pointed to antibodies and antiviral treatments—with a special nod to Regeneron's dual antibody cocktail—as promising options ahead of a vaccine. Several vaccine candidates will emerge by 2021, DePinho predicted. And meanwhile, he singled out promising developments in CRISPR-based diagnostics to test for the virus.
UPDATED: Monday, June 29 at 9:25 a.m. ET
China's Central Military Commission OK'd CanSino Biologics' coronavirus vaccine, Ad5-nCoV, for use by the military for one year, the company said Monday. CanSino developed the shot—one of eight currently approved for human testing in China and abroad—with its home country's Academy of Military Sciences.
Pfizer vaccine partner BioNTech scored $250 million in a private placement led by Singapore-based holding company Temasek. The company's COVID-19 vaccine, BNT162, is expected to return clinical trial data by July. Competing with mRNA shots from Moderna and CureVac, BioNTech has already awarded Chinese rights for BNT162 to Shanghai Fosun. Story
Plus, the Brazilian government said Saturday it had inked a $127 million deal to churn out doses of AstraZeneca's Oxford-partnered COVID-19 vaccine in the country. Brazil will produce an initial 30 million doses, with the first half arriving by December and the second half in January, the country's deputy health official said. Story
Global demand for Roche's COVID-19 tests has outstripped supplies, chairman Cristoph Franz told a Swiss newspaper. Currently, the company dispenses tests based on medical needs and where the highest infection rates are, Franz said. The company will ramp up production on its antibody tests to meet the demand.
Meanwhile, WHO chief scientist Soumya Swaminathan offered an insider take on the vaccine race Friday: AstraZeneca currently leads the pack with its University of Oxford-partnered shot, with Moderna close behind, Swaminathan said. Last week, WHO launched a new initiative with Gavi, the Vaccine Alliance and CEPI to secure equitable distribution of 2 billion shot doses around the globe.
U.K.-based biotech Tiziana Life Sciences inked a deal with STC Biologics to manufacture a monoclonal antibody that could curb cytokine storm in severely ill COVID-19 patients. Originally nabbed from Novimmune in 2017, the drug, TZLS-501, blocks IL-6, an immune system pathway thought to be a major culprit in the cytokine storm. The company has also partnered with Sciarra Laboratories to develop a handheld nebulizer that delivers the drug straight to the lungs.
In an interview with Forbes, Roche Pharmaceuticals CEO Bill Anderson touched on the company's COVID-19 response: Roche's diagnostic partners released the first commercially available coronavirus test in mid-March and pivoted to run phase 3 trials on the arthritis drug Actemra after learning that Chinese and Italian researchers were studying the med in severe COVID-19 pneumonia. Roche expects results from its own Actemra studies by the end of the summer.
Plus, the U.S. Department of Homeland Security (DHS) issued a report Thursday outlining shortages of more than 200 drugs and medical supplies because of COVID-19 and warned of more supply constraints in the near future. Active ingredients are running scarce because of plant closures in China and India, the report said, citing a common concern since the pandemic began. Shortages of cheaper, generic meds would disproportionately affect low-income Americans, the DHS warned.
UPDATED: Friday, June 26 at 3:40 p.m. ET
The WHO has tapped GAVI, the Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations (CEPI) in an $18 billion bid to dispense COVID-19 vaccines equitably around the globe. The move comes as several developed nations have invested heavily in vaccine makers for preferred access to those shots. For its part, the trio aims to pool funds into multiple vaccine projects rather than backing a single company. Currently, the group has only raised $3.4 billion toward its goal.
The Trump Administration may begin screening multiple people for COVID-19 at the same time in what's known as pool testing, NIAID director Anthony Fauci told the Washington Post on Friday. A group of patients would be given a single coronavirus test, with individual tests to follow in the event of a positive result. This would allow officials to test more people with fewer resources; but pool testing only works if the majority of the population is uninfected, Fauci said.
Meanwhile, the CDC estimates that 20 million Americans have contracted the virus, based on the number of known cases multiplied by the average rate of antibodies found during serology tests. That's 10 times more than the official case count, which points to a far greater number of asymptomatic patients with the disease, officials said. Some good news? Those boosted stats would also mean the percentage of U.S. COVID deaths is lower than thought.
Plus, a "biohacker" who once made DIY CRISPR kits thinks he can develop a working COVID-19 vaccine ahead of Big Pharma. Having slapped together his own DNA-based shot with publicly available spike proteins, Josiah Zayner aims to inject himself—and two partners—in order to reproduce trial results from May showing that a DNA vaccine triggered an immune response in monkeys. At least one bioethicist has taken issue with Zayner's sample size. Story
UPDATED: Friday, June 26 at 9:15 a.m. ET
Japan is the latest country to go after doses of AstraZeneca and the University of Oxford's COVID-19 vaccine, AZD1222. On Friday, Japanese drugmaker Daiichi Sankyo said it's in talks to carry out formulation, packaging and storage of AZ's shot in Japan. Daiichi said it's also in talks with the Japanese government to ensure the country has the AZD1222 doses it needs. Story
Plus, the call for more dexamethasone studies rolled on as U.S. doctors noted that the well-known steroid actually increased the odds of death in mildly ill COVID patients, according to early data from the recently unveiled Recovery Trial. The steroid dampens the body's immune system–good for late-stage patients fighting cytokine storm, but potentially lethal for those in the early throes of the disease. Those patients rely on their immune systems to thwart the infection, doctors say.
Meanwhile, as competition between remdesivir and dexamethasone promises to heat up, an infectious disease analyst at GlobalData thinks the drugs might serve patients better as a team. Gilead Sciences' antiviral targets coronavirus symptoms directly, while the well-known steroid dexamethasone slows hyper-inflammatory damage. Remdesivir is already in combo testing with another anti-inflammatory, tociluzimab.
The FDA has fast tracked NeuroRX and Relief Therapeutics' synthetic peptide Aviptadil to treat COVID-19 patients with severe respiratory symptoms. The drug reduces lung inflammation and protects cells in organs thought to be an entry point for the virus. Aviptadil is currently in phase 2/3 U.S. trials to lower death rates and boost blood oxygen levels in COVID patients.
And German drugmaker Merck KGaA said it scored FDA clearance to launch phase 2 studies on its investigational drug, M5049, to treat cytokine storm in COVID-19 patients who develop pneumonia. Results are expected around the end of this year, Merck said.
On Thursday, the U.S. broke its record total of new coronavirus infections for the second day in a row, with many states spared early on in the pandemic now facing major outbreaks. In a sign of apparent urgency, the White House will hold a coronavirus task force briefing on Friday afternoon—the first one in nearly two months.
UPDATED: Thursday, June 25 at 3:45 p.m. ET
The U.S. NIH may own patent rights to the technology behind Moderna's frontrunner COVID vaccine, Axios reports. In a provided statement, NIH scientists took credit for the stabilized spike proteins that enable coronavirus vaccine development, which the government has sought to patent. That increased stake in Moderna's shot could allow the NIH to deploy vaccine tech to other researchers without the drugmaker's consent and would likely aid in broader efforts to make the final dose low-cost and widely available.
Meanwhile, Oxford University launched a trial for its COVID-19 vaccine in South Africa—the first in the country and the continent. The university has launched adjacent trials in Brazil and aims to ramp up enrollment in U.K. studies with an extra 10,000 participants.
Testing giant LabCorp rolled out a new COVID-19 antibody test that it will offer to biopharmas, blood banks and hospitals. The company's new PhenoSense assay is based on the same platform LabCorp has used to test vaccines for other viral infections such as HIV, Ebola and the flu. In addition to its use in evaluating COVID-19 hopefuls, LabCorp said the new test will also help screen donations of convalescent plasma for the virus. Story
A new federal analysis suggests that pregnant women with COVID-19 are more likely to be hospitalized or require mechanical ventilation, but experts have taken issue with the study. The data, provided to the CDC, compared 8,207 pregnant women with 83,250 who were not. More than 31% of those who were pregnant had to be hospitalized compared with 6% of non-pregnant women, but experts at the CDC want to know why those participant numbers are so off.
Amid critiques of the Small Business Administration and the Department of Transportation, the Government Accountability Office (GOA) blasted the CDC on Thursday for its inconsistent COVID testing. The watchdog claimed that failure to adequately test for the virus has confused infection counts, treatments and reopening efforts.
UPDATED: Thursday, June 25 at 11:45 a.m. ET
Moderna has tapped Catalent to complete fill-finish work on its mRNA vaccine candidate, with plans to churn out an initial 100 million doses for the U.S. market by the third quarter. Catalent will supply vial filling and packaging services at its Bloomington, Indiana biologics plant and aims to support phase 3 shot trials by providing storage, labeling and more at its Philadelphia sites. Story
And the Coalition for Epidemic Preparedness Innovations (CEPI) is eyeing manufacturers to produce 4 billion COVID-19 vaccine doses a year, with the goal to provide those shots equitably across the globe. CEPI has poured $829 million into nine different vaccine makers so far and hopes to build two or three plants per vaccine. For shots using newer mRNA platforms, CEPI says it will have to build manufacturing sites from scratch. Story
The European Medicines Agency's (EMA) human medicines committee is recommending a conditional marketing authorization for remdesivir to treat COVID-19 in patients 12 and up who develop pneumonia or require oxygen support. Committee researchers conducted a rolling review of the drug well ahead of Gilead Sciences' June 5th marketing application. Remdesivir is the first COVID treatment recommended for approval across the continent.
Plus, researchers found that cancer patients treated with checkpoint inhibitor therapies—which trigger an immune response to attack tumors—are at greater risk of developing serious COVID symptoms than patients on other treatments like chemo, according to data published in Nature Medicine. Scientists say that the data is too sparse to alter current COVID-19 treatments, but pushed for increased vigilance in patients juggling both diseases. Story
And U.S. demand for dexamethasone—recently hailed as a hopeful COVID-19 treatment in an Oxford University study—is outstripping current supplies. Group drug purchaser Vizient, which supplies meds to nearly half of all U.S. hospitals, said demand for the drug had spiked 610% as of Thursday. Plus, the FDA says injectable dexamethasone has been in shortage since February of last year—well before its new COVID indications. Story
On the heels of a rocky hearing before the House Energy and Commerce Committee Tuesday, the FDA has launched a new podcast—FDA Insight—that explores the agency's pandemic response. This week's guest? Commissioner Stephen Hahn, in interview with deputy commissioner of medical and scientific affairs, Dr. Anand Shah.
UPDATED: Wednesday, June 24 at 3:00 p.m. ET
Dexamethasone's swift rise as a coronavirus treatment could scupper pricing plans for Gilead Sciences' remdesivir—the current standard in severe COVID-19. The Institute for Clinical and Economic Review (ICER) pegged its estimated price for remdesivir at $4,580 to $5,080 on Wednesday, with one caveat: If dexamethasone's benefits are confirmed via peer review, ICER will have to knock remdesivir's cost-effective price down by several thousand. Story
The U.K. government is launching a research program to validate the accuracy of new coronavirus tests in and out of the lab. A suite of British universities, NHS trusts and research groups have joined the review, called the COVID-19 National DiagnOstic Research and Evaluation Platform, or CONDOR, in a push to unite Britain's test validation efforts. Story
Ancient med colchicine—used to treat inflammatory diseases for centuries—may curb severe COVID-19, according to new data from a Greek study that tested the drug in 105 hospitalized patients. Of the 55 patients dosed with colchicine, only one grew sicker, while seven of the 50 on antivirals and antibiotics alone became severely ill. American physicians agreed the trial had its limits, but additional U.S. studies are underway to test the old drug against the novel virus.
Former Merck exec Michael Rosenblatt warned that COVID-19 challenge trials, which intentionally infect patients with the virus to speed up vaccine development, aren't worth the risk. For one, there's still no foolproof treatment for the disease. Coupled with a lack of understanding of the virus' long-term effects and its ability to ravage even young, healthy patients, Rosenblatt fails to see how the dangers are worth it.
At Tuesday's House Energy and Commerce Committee hearing, NIAID director Anthony Fauci stood by earlier predictions that a COVID vaccine could hit the U.S. market by end of year. Still, Fauci called the U.S. pandemic response a "mixed bag," pointing to a "disturbing surge" of cases across the country that signal the virus is far from contained.
UPDATED: Wednesday, June 24 at 9:27 a.m. ET
With case counts plunging back home, the Chinese National Biotec Group (CNBG) nabbed approval to run phase 3 trials of an unnamed COVID-19 shot in patients in the United Arab Emirates. An arm of China's state-owned Sinopharm, CNBG has two shots in the works and joins a host of other Chinese drugmakers—such as Clover and Sinovac—forced to launch human trials abroad.
Plus, Japan's successful campaign to thwart the virus could hinder its COVID research. Some 54 coronavirus trials are locked in the recruitment phase, and while Fujifilm's flu med Avigan has already scored approval for COVID-19 in Russia and India, Japan doesn't expect a verdict on the drug until at least July. As domestic cases continue to plummet, Japan may also look overseas to complete its COVID-19 trials.
AstraZeneca inked a 10th supply deal for its candidate vaccine, AZD1222, tapping Scotland-based Symbiosis Pharmaceutical. AZ kept quiet on the financial details, and it's unclear how many doses Symbiosis aims to provide.
And Mumbai-based Ipca Laboratories' partial reprieve from its FDA import alert proved short-lived. Back in March, the FDA allowed the drugmaker to supply active pharmaceutical ingredients for would-be COVID treatment hydroxychloroquine—on an emergency basis, at least. But with that drug's popularity waning, and shortages resolved, the FDA reinstated the import restrictions, Ipca said Wednesday.
FDA chief Stephen Hahn broke with the White House before the House Energy and Commerce Committee on Tuesday, testifying that "data and science," not "Warp Speed," would dictate its approval of a COVID-19 vaccine. The Trump administration's Operation Warp Speed vaccine program aims to deliver 300 million doses by January, but Hahn said the FDA will work on its own timeline. At the hearing, committee Chairman Frank Pallone also countered President Donald Trump's assertion that the U.S. was performing fewer COVID tests to juke its case counts.
UPDATED: Tuesday, June 23 at 3:32 p.m. ET
Sanofi, absent from the list of reported "Warp Speed" finalists, thinks proven tech—not speed—will yield a successful vaccine, CEO Paul Hudson said Monday. Sanofi is working with GlaxoSmithKline on a more traditional protein subunit vaccine, which the company says could be ready next summer. That's months after other companies' stated goals, but even if Sanofi doesn't win the vaccine race, the world will still need its vaccine doses, Hudson said. Story
And it's not as if the French pharma has sworn off new vaccine tech: During its R&D day Monday, Sanofi said it had put up $300 million cash, plus $125 million in equity and $1.9 billion in potential milestones toward Translate Bio's mRNA vaccine platform. The partners are looking at "multiple" COVID-19 candidates in vivo, aiming to launch human trials in the fourth quarter. Story
Drugmakers looking to shift operations stateside might find a new "onshoring" utopia in a former Bristol Myers Squibb plant—or so says Lincoln Equities Group, a private equity firm that snapped up the site last week. It's now peddling space at the 433-acre campus in Hopewell, New Jersey to companies already tapped by the U.S. government to boost onshore production of pandemic-related drugs. Story
Speaking of American drug manufacturing, India-based contract manufacturer Piramal Pharma Solutions snared a former G&W oral solids plant in Sellersville, Pennsylvania, to beef up its U.S. operations. Piramal plans to convert the site into a possible home for "COVID-19 management drug opportunities." The company runs an API facility in Riverview, Michigan, which it expanded earlier this year. Story
What's it like juggling cancer treatments with the COVID-19 outbreak? Journalist Katie Couric recently interviewed one patient about her struggles as part of Merck's new virtual oncology series. Future installments of the series,"Katie Couric Explores: Cancer During COVID-19," will debut in the coming weeks, highlighting a range of patients and perspectives. Story
And Massachusetts governor Charlie Baker said Tuesday that only 2.5% of the 17,617 people who sought testing statewide after attending protests over George Floyd's death tested positive for COVID-19. Demonstrators' use of face masks likely kept those numbers low, Baker said.
UPDATED: Tuesday, June 23 at 9:00 a.m. ET
Researchers from the U.K.'s Recovery Trial released a data preprint on the effects of dexamethasone in hospitalized COVID-19 patients, which showed that a 10-day, 6mg course of the long-established steroid slashed death rates by one-third in patients on ventilators and by one-fifth in those on oxygen support. The drug failed to lower mortality rates in milder cases. More than 2,000 patients were dosed with the drug in the 4,321-person trial, still awaiting peer review. Story
A pig study from a team at Britain's Pirbright Institute found that two doses of AstraZeneca's COVID-19 vaccine candidate—now known as AZD1222—provided greater immunity against the virus than one did. Pigs given an initial prime dose followed by a booster shot produced a stronger antibody response than those that received a single dose. Now, researchers aim to find out if the same is true in humans.
Inovio nabbed $71 million from the U.S. Department of Defense to scale up production of its Cellectra smart devices, used to deliver the company's COVID shot, INO-4800, directly into the skin. Inovio aims to release interim phase 1 results on its DNA-based candidate by month's end, with phase 2/3 efficacy trials slated to begin this summer. Inovio won previous funding to test the Cellectra devices from the Bill & Melinda Gates Foundation and the Center for Epidemic Preparedness Innovations (CEPI). Story
And on Sunday, Cipla and the privately held Hetero Labs joined the parade of Indian drugmakers that have scored approval to market a generic form of Gilead Sciences' remdesivir to treat COVID-19. Cipla said it aims to sell the drug for less than 5,000 rupees ($66) per vial. Beximco Pharmaceuticals, based out of Bangladesh, first introduced a remdesivir knock-off in May, with a planned price of $59 to $79 per vial, Reuters reported.
And a professor from Chongqing Medical University—which published data Sunday showing antibody levels sank sharply in recovered COVID-19 patients—warned that Chinese patients infected with an earlier form of COVID-19 may also be vulnerable to a common viral mutation, dubbed D614G. The mutation, which boosts the virus' "spikes," has spread rapidly through Europe. Now, some health experts worry that the new strain will scupper vaccine efforts based on an earlier form of the virus.
The Trump administration is gunning for the CDC over alleged missteps in its handling of the coronavirus pandemic, four top officials told Politico. President Donald Trump and CDC director Robert Redfield have sparred via public statement these past few months; now, amid criticism of its own pandemic leadership, the White House is considering an audit of the agency's response.
Political pressure to race toward reopening and some very personal threats from the public have spurred health officials to leave their posts, the Washington Post reports. While shutdown measures are broadly popular, public health officials in California, Colorado, Ohio and more have weathered particularly nasty attacks.
UPDATED: Monday, June 22 at 3:36 p.m. ET
Gilead Sciences nabbed FDA clearance to test an inhaled form of remdesivir in healthy volunteers as it looks to pit the drug against early-stage COVID-19, CEO Daniel O'Day said Monday. Remdesivir is currently under emergency use authorization from the FDA in hospitalized COVID patients, but the most recent clinical data show the drug is less helpful in mild cases and patients on ventilators. Story
The FDA has received a staggering 106 adverse event reports for Abbott Laboratories' divisive ID NOW rapid COVID-19 test—up from 15 false negative reports in mid-May that prompted a rare public warning from agency over the test's accuracy. Now, the FDA is taking flak for authorizing the test in the first place, with critics calling the diagnostic's odds of correctly yielding a positive result—reportedly pegged at 80%—too low to merit approval. Story
Backed by local government and the British NIH, the University of Southampton will begin testing a new, swabless coronavirus test in a four-week, at-home trial targeting healthcare workers and students. The trio aims to distribute and collect the saliva-based test kits—designed by the U.K.'s OptiGene—to 14,000 participants each week, amid ongoing reviews of other swabless diagnostics from Chronomics, Avacta, Map Science and more. Story
Researchers at China's Chongqing Medical University found that antibody levels in recovered COVID-19 patients sank sharply after two to three months, according to a study published in Nature Medicine. On average, COVID-fighting antibodies dropped more than 70% in both symptomatic and asymptomatic patients, raising concerns about long-term immunity against the virus.
The U.S. and Brazil continue to lead the world in new coronavirus infections, according to a Reuters tally, with U.S. numbers on the rise again as twelve states reported record increases in cases last week. On Saturday, Reuters tallied over 30,000 new cases in the U.S., the highest daily total since May 1.
Plus, 183,000 new cases were reported globally on Sunday, according to WHO—the most in a single day since the outbreak started.
UPDATED: Monday, June 22 at 9:13 a.m. ET
The National Institutes of Health axed its Orchid study testing the effects of hydroxychloroquine in hospitalized COVID-19 patients. Over 470 patients were enrolled in the study—run in conjunction with the National Heart, Lung and Blood Institute—at the time of its termination. A data and safety monitoring board urged the NIH to stop testing the drug in COVID-19 patients Friday, citing no safety concerns, but no benefit against the virus, either.
Meanwhile, Novartis discontinued its own trial on the drug over recruitment challenges. In a Friday release, the Swiss drugmaker said it lacked participants to finish its study on hydroxychloroquine in COVID-19 patients, but it added that no safety or efficacy conclusions had been reached. Novartis pledged to keep supplying the drug for ongoing trials and upon government request. Story
On Monday, Indian biotech Cipla won approval from the country's drug regulator to churn out a generic version of Gilead Sciences' remdesivir, dubbed Cipremi, to treat COVID-19. Gilead signed a non-exclusive license with Cipla to market the remdesivir generic in May. For its part, Cipla will offer training on how to administer the drug and run a phase 4 trial studying the antiviral's effect in Indian COVID patients.
Many COVID-19 treatments fight the disease in its later stages, but Ridgeback Biotherapeutics aims to halt COVID-19 early on with the launch of a dual phase 2 trial of its antiviral, EIDD-2801, in both hospitalized and newly-diagnosed patients who are still at home. Ridgeback hopes that by beating back the disease in its early stages, it can reduce the time patients are infectious and limit the virus' spread. The company has churned out thousands of doses of the drug ahead of a successful run in the clinic. Story
Plus, a Jefferies health care strategist thinks the U.S. is likely to get a COVID-19 shot ahead of the November election. The reason for that confidence? Political pressure to launch a vaccine before voters hit the polls, widespread federal funding of vaccine research and lower regulatory hurdles for a vaccine candidate to score emergency approval. Story
UPDATED: Friday, June 19 at 3:13 p.m. ET
Three chairs from the House Committee on Oversight and Reform penned a letter (PDF) to FDA commissioner Stephen Hahn urging him to divulge the agency's COVID-19 vaccine plans. The letter also outlined steps Hahn could take to bolster public faith in the final shot: improving clinical trial design, making vaccine data more accessible and boosting coordination among public health agencies.
Once hailed as a "game changer," hydroxychloroquine use in patients admitted to U.S. hospitals for COVID-19 plunged 26.8% between March 15 and May 3, according to a chart by Aetion and HealthVerity that tracked hospital visits and medications prescribed for the virus. In early June, The Lancet retracted papers touting the drug's promise in COVID patients, and on Monday, the FDA scrapped its emergency use authorization for the drug.
Glenmark Pharmaceuticals got the OK (PDF) from India's drug regulator to start cranking out its generic antiviral favipiravir—sold by Fujifilm under the brand name Avigan—to treat mild-to-moderate COVID-19 patients in India. The drug was fast-tracked for approval and is restricted for emergency use. Patients will have to sign an informed consent form before starting treatment.
On the whole, biopharma market caps sank in the first quarter of 2020, but companies with COVID drugs in the works fared slightly better, GlobalData reports. The analytics company tracked a 12.6% drop in market cap for biopharmas without a COVID candidate, while companies with treatments in the pipeline only dipped 5.8%. Meanwhile, Regeneron and Gilead Sciences led the pack at 33% and 14% growth in Q1, respectively.
Plus, medtech companies are tapping "digital biomarkers" to study the impact of COVID-19 and develop early warning systems for the virus' more obvious symptoms. MIT spinoff Empatica recently inked a deal with BARDA to run tests on a smartwatch designed to detect COVID-19 through shifts in the wearer's vitals. Plus, Oura is using its activity-tracking smart ring to monitor more than 600 healthcare workers for early signs of the illness. Meanwhile, Evidation Health and Duke University have launched virtual research apps to study the pandemic's broader public impact. Story
UPDATED: Friday, June 19 at 9:30 a.m. ET
In May, Roche kicked off its Evaluating Minority Patients with Actemra (EMPACTA) trial to study the arthritis med in underserved patients hospitalized with COVID-19 pneumonia. Roche told Fierce Pharma that it aims to enroll around 375 patients globally in the phase 3 trial. The study first launched via its Genentech unit in the U.S. and recently expanded to other countries, including South Africa, Kenya, Brazil, Mexico and Peru.
Meanwhile, officials close to deal talks confirmed the EU is negotiating with Johnson & Johnson to claim upfront doses of its COVID-19 vaccine. The advanced purchase would mark the EU's first move to capitalize on an emergency fund of more than €2 billion ($2.3 billion) to strike deals with vaccine makers. An unnamed EU health official said the deal could be announced as early as next week—but added that it might not materialize at all. The EU is reportedly seeking shot supplies from Sanofi as well. Story
And a poll by The Associated Press and the NORC Center for Public Affairs Research found that only 20% of Americans expect a COVID-19 vaccine to hit the market this year, with 61% citing an expected release in 2021. Forty-nine percent of those surveyed said they'd get the vaccine, and 79% said an effective shot was an important step in reopening efforts. Side effects were a major concern among the 20% who said they wouldn't get vaccinated.
Plus, China-based Clover Biopharmaceuticals says it has dosed patients in phase 1 trials for its Trimer-Tag COVID-19 vaccine candidate, SCB-2019. Clover entered the vaccine race early, tapping GlaxoSmithKline for an adjuvant in February, followed by a deal with Dynavax for additional vaccine ingredients in March. Now, the company aims to turn in top-line data in two months, with phase 2b/3 trials slated for the end of the year. Story
U.S. hospitals in regions with new case spikes are prescribing dexamethasone to treat their sickest patients—ahead of full trial results on the steroid in COVID-19. A University of Oxford press release this week revealed data showing the drug slashed death rates in COVID-19 patients on oxygen support, followed by rapid approval for the drug in the U.K. Many U.S. doctors similarly started using Gilead Sciences' remdesivir after its data-reveal-by-press-release earlier this year.
The FDA allied with the Reagan-Udall Foundation and Friends of Cancer Research to launch a new COVID-19 testing research project dubbed the COVID-19 Diagnostics Evidence Accelerator. The research effort builds on the group's earlier Therapeutic Evidence Accelerator project, launched in April, and aims to test the performance of both PCR and antibody tests alongside trends in the disease's symptoms, progression and possible immunity. Story
People with type A blood may have a 45% higher risk of contracting severe COVID-19 than those with other blood types, according to a study in the New England Journal of Medicine. O blood types had the lowest risk of developing severe symptoms. Now, scientists hope genetic tests and blood typing will help identify at-risk patients ahead of time.
UPDATED: Thursday, June 18 at 3:29 p.m. ET
Amid an international tussle for COVID-19 supplies, European countries are reportedly lining up to secure doses of Johnson & Johnson's candidate vaccine. The European Commission and a four-way partnership between Germany, France, Italy and the Netherlands have reached out to J&J, Reuters reported, with little detail to offer. Meanwhile, as the U.S. and wealthy EU nations ink advanced purchase deals, some health experts worry poorer countries will be squeezed out of the first wave of immunizations.
In a study by Italy's drug regulator, Aifa, Roche's anti-inflammatory drug Actemra failed to help patients with early-stage COVID-19 pneumonia—but it's still under study in advanced cases. Roche is testing the arthritis med solo and in combination with Gilead Sciences' remdesivir to treat severe COVID-19 pneumonia, and it's building an "end-to-end" Actemra supply chain in the U.S. through its Genentech unit. Story
Plus, Regeneron says its antibody cocktail has an edge over lone drugs used to fight COVID-19: The antibody duo, dubbed REGN-COV2, binds to separate regions of the virus, thwarting its ability to mutate and become drug-resistant. The cocktail is currently in adaptive phase 1/2/3 trials in hospitalized and non-hospitalized patients. Story
The FDA walked back an emergency green light for Chembio Diagnostic Systems' fingerstick COVID-19 antibody test, authorized in mid-April. In a new test-validation effort with the CDC and NIH, researchers found Chembio's version yielded false positives, and an HHS report pegged the test's positive predictive value at just 18.7%. Story
Drugmakers Esperion, Horizon, Eisai and more have embraced virtual technology and quick footwork to adapt—rather than delay—drug launches during the pandemic. Now, some of those drugmakers are reaping unexpected boons from their digital outreach, and all plan to keep the new tech in use once the pandemic subsides. Story
Emergent has climbed the ranks as the U.S. manufacturer of choice for COVID-19 vaccine supplies. Now, the company will shell out $75 million to revamp a plant for viral vector production. Emergent said it plans to launch the newly outfitted plant by 2023 as part of its "molecule-to-market" gene therapy CDMO. Story
UPDATED: Thursday, June 18 at 11:06 a.m. ET
The Trump administration will employ a "tiered-approach" to get COVID-19 vaccines from its "Warp Speed" program to vulnerable Americans free of charge, an unnamed administration official said Tuesday. The administration will put the elderly, immunocompromised and healthcare workers first in line for the shot, the official said.
More than a quarter of the 116,000 Americans whose lives have been claimed by COVID-19 were black, according to an APM Research Lab report, yet African Americans are largely unrepresented in clinical trials for the disease. Clinicians warn a vaccine might not work for African Americans if they aren't enrolled in trials, but pharma will need to earn the trust of the community, which still recalls injustices like the Tuskegee Experiment.
Amid growing concern that government pressure has compromised the agency, San Francisco surgeon Nisarg Patel called for the FDA to become an independent body "insulated from political interference." Earlier this week, the FDA had to overcome President Donald Trump's repeated praise for hydroxychloroquine as it axed emergency authorization for the drug in COVID-19 patients over efficacy and safety issues.
Here's another move that could raise eyebrows: The FDA could choose to wave through a vaccine early if phase 3 trials drag on, pharma execs told ProPublica: It could authorize a shot as an "immune correlate" if it induces antibodies at similar levels to those produced by a natural infection. That shot would also need to be on track to pass muster in full clinical trials.
And WHO is reviewing interim data on patients treated with the combination HIV drug lopinavir/ritonavir for COVID-19 as part of its ongoing Solidarity Trial. The trial pits established drugs against COVID-19, including Gilead Science's remdesivir. Wednesday, WHO halted the trial arm studying hydroxychloroquine after the FDA revoked its authorization of the drug in COVID-19.
Plus, a West Health and Gallup study showed 9 in 10 U.S. adults fear COVID-19 will push pharma companies to hike drug prices. Those concerns were more common in respondents who identified as Democrats; Republicans reported the least level of concern. Of the 1,016 Americans surveyed, many worried that insurance premiums and cost of care would also rise in the wake of the pandemic.
UPDATED: Wednesday, June 17 at 3:30 p.m. ET
Novavax tapped AstraZeneca vet Filip Dubovsky to serve as chief medical officer at the company, where he will head up development of its COVID-19 vaccine. Dubovsky oversaw work at the PATH Malaria Vaccine Initiative before his time at AZ and joins Novavax on the heels of three major fundraising wins for its coronavirus work. Story
With a fresh €300 million ($337 million) from the German government, CureVac got the OK to start a phase 1 trial of its mRNA-based COVID-19 candidate—now called CVnCoV—in Belgium and Germany. The company said it plans to test the shot's safety and optimal dose in a 168-person study "promptly." Story
The U.S.' "Operation Warp Speed" vaccine program took heat—again—for its apparent choice of new technologies over tried-and-true vaccine platforms. NIH director Francis Collins said those new approaches are attractive because there's an obvious "need for speed," but other U.S. scientists think the program should hedge its bets by funding older, proven vaccine tech, too.
And how did Moderna's COVID shot surpass some Big Pharmas to win "Warp Speed" status? CEO Stéphane Bancel touted five reasons in an interview with CNBC—and said the company's vaccine has a 80-90% chance of winning FDA approval. Bancel later clarified that his prediction referred to the shot proving at least 50% effective; he'd need more evidence before rating the odds of 90% efficacy. As it moves full speed toward phase 3, Moderna still hasn't released complete phase 1 vaccine data.
Gilead Sciences will study remdesivir's efficacy in children and young adults with COVID-19 in a single-arm phase 2/3 trial enrolling 50 patients. Gilead has provided the drug to pediatric patients under its compassionate use program since February. The trial will take place at 30 sites across Europe and the U.S.
PTC Therapeutics thinks its early-stage cancer drug, PTC29, could be the latest med repurposed to treat cytokine storm in COVID-19 patients. PTC plans to kick-start a U.S.-based phase 2/3 trial in the "coming days" and aims to run other tests in Europe, Brazil and Australia. Story
And SAB Biotherapeutics is making polyclonal antibodies to fight COVID-19 with an unlikely ally: cows. The company injects the virus into cattle modified with human DNA, which then produce high-neutralizing antibodies that SAB hopes to use in coronavirus patients. SAB has tested its cow-based antibodies to treat influenza and MERS—another coronavirus—and plans to pit them against COVID-19 through a partnership with the University of Pittsburgh.
UPDATED: Wednesday, June 17 at 9:35 a.m. ET
U.S. doctors are calling for more data after dexamethasone's rapid-fire approval for COVID-19 in the U.K. Top-line data were released Tuesday showing the steroid cut death rates in patients on oxygen and ventilators, followed by an endorsement from the British government hours later, but doctors worry they could have another hydroxychloroquine situation on their hands. A report touting that drug's effectiveness against COVID-19 was retracted by The Lancet in early June over data concerns. Story
The U.K.'s Dr. Hilary Jones urged caution in the wake of dexamethasone's approval, noting that the drug reduced the mortality rate among critically ill patients to 28%—and that's still high. He also warned against public stockpiling of the drug, stating, "it's not a preventative."
Meanwhile, WHO welcomed the dexamethasone data and said it would update its clinical guidance for the drug in COVID-19, with the caveat that it's most useful in patients on oxygen support. The steroid, used to treat inflammatory conditions since the 1960s, is on WHO's Model List of Essential Medicines and is currently off-patent and available in most countries at low cost.
And the U.S. is reportedly stuck with 66 million doses of hydroxychloroquine after the FDA axed approval for the drug in COVID-19 this week. The antimalarial won an emergency authorization in March and was touted as a "game-changer" by President Donald Trump before its effectiveness came under fire. Now, U.S. officials are turning to companies that donated to the stockpile to "determine the available options" for the excess pills.
Brazilian health officials blasted the FDA's call to revoke approval for hydroxychloroquine in coronavirus patients, saying the studies cited in the decision "cannot be used as examples for Brazil or the rest of the world." The country said it will now recommend the drug for early treatment of COVID-19 in children and pregnant women.
As the European Union races to keep up with China and the U.S. in the COVID-19 vaccine effort, the European Commission launched a proposal Wednesday to temporarily relax rules on drug trials using genetically modified organisms (GMOs). E.U. officials warned that several COVID shots in development could hit delays if Europe fails to ease its strict GMO regulations.
And French president Emmanual Macron pledged to contribute €200 million ($224 million) to beef up the country's drug manufacturing during a speech at a Sanofi facility after the company unveiled plans to build a new vaccine plant in Eastern France. Macron added that he hopes to reserve French vaccine supplies from Sanofi in the coming days.
UPDATED: Tuesday, June 16 at 3:30 p.m. ET
Hours after the release of trial data that showed the steroid dexamethasone slashed fatality rates in severely-ill COVID patients, the U.K. government gave the OK for Britain's National Health Service to prescribe it for patients on oxygen and ventilators. Anticipating a positive outcome, the U.K. government had been stockpiling the drug and added it to its parallel export list, which bans companies from selling off supplies meant for U.K. markets. Story
Plus, the British government pumped $56 million into Imperial College London's COVID-19 vaccine effort, which uses self-amplifying RNA technology to trigger an immune response. Imperial aims to enroll 300 healthy participants in clinical trials in the "coming weeks" and, in the event of strong results, plans to start phase 3 trials as soon as possible. Story
Sanofi will spend $544 million to build a "state-of-the-art" vaccine plant in Neuville sur Saône, France, to get the jump on future pandemics, the company said. The site, dubbed Sanofi's Evolutive Vaccine Facility, will be built over the next five years and make room for 200 new staffers. The facility will boast the capacity to make three or four separate vaccines at once, and can pivot to produce a single shot if a new pandemic strikes, Sanofi said. Story
Novavax nabbed $200 million toward its COVID-19 vaccine when it sold off nearly 4.4 million shares through a private placement with life sciences investment firm RA Capital on Monday. The company's coronavirus work recently scored two other cash infusions from the Coalition of Epidemic Preparedness Innovations and the U.S. Department of Defense. Story
More than 200 clinical trials stalled by the coronavirus pandemic have resumed or finished, according to GlobalData analysts, but snags in enrolling patients and finding proper testing sites will likely delay future approvals, the company's associate director of trials intelligence warned. Story
Verily expanded its COVID-19 testing program to more than 130 cities and deployed more than 256,000 testing kits through a growing network of public and private contracts, the company said. Next, Verily aims to roll out self-performed nasal swab tests at all its sites. Those swabs are currently used at nearly 100 pharmacies through a partnership with Rite Aid and the HHS. Story
UPDATED: Tuesday, June 16 at 9:30 a.m. ET
AstraZeneca's COVID-19 candidate vaccine will protect against infection for about a year, CEO Pascal Soriot told a Belgian radio station on Tuesday. The comments come as experts debate how long coronavirus antibodies would fight a new Sars-CoV-2 infection. Story
Plus, Moderna, which reportedly has a vaccine finalist in the Trump administration's Operation Warp Speed project, snagged Amgen and Johnson & Johnson vet Ray Jordan to fill the role of chief corporate affairs officer starting Monday. Jordan has been consulting for Moderna for the past four months.
And China's state-owned Sinopharm reported (Chinese) phase 1/2 results for its inactivated COVID-19 candidate vaccine, which hit a seroconversion rate of 100% after two doses 28 days apart. Currently, 1,120 patients have completed two doses in the phase 1/2 trial. Story
Singapore's Duke-NUS Medical School plans to start safety trials of its messenger RNA (mRNA)-based coronavirus vaccine this week, with broader studies on COVID-infected patients set for the coming months.
Gilead Sciences has enlisted Indian pharma Dr. Reddy's Laborities to make and sell remdesivir in 127 countries, including India, in a continued effort to supply the COVID-19 treatment to low-income countries and regions with "high obstacles" to health care.
And on the same day the FDA revoked emergency use authorization for hydroxychloroquine in COVID-19 patients, the agency warned that taking the drug in combination with Gilead's antiviral remdesivir to treat the virus could hurt the latter's performance.
U.K. experts working on the COVID-19 Recovery Trial found that the arthritis and asthma drug dexamethasone cut death risk in patients on ventilators from 40% to 28%, and those on oxygen from 25% to 20%. The drug could prove helpful for patients hit with cytokine storm, but studies failed to show the drug's effectiveness in less-ill patients.
The Wyss Institute at Harvard inked a deal worth up to $16 million with the U.S. Defense Advanced Research Projects Agency (DARPA) that leverages its existing computational drug pipelines and human organ chip technologies—which allow researchers to study the virus—to pinpoint and test drugs that could be repurposed to treat COVID-19. Wyss also plans to carry out RNA analysis at the Broad Institute of Harvard and MIT with samples supplied by hospitals in Boston and New York City.
Humanigen shares jumped 30% when the company turned in positive trial results for its antibody COVID treatment, lenzilumab, on Monday. Disgraced "Pharma Bro" Martin Shkreli briefly headed up Humanigen, which was then known as KaloBios Pharmaceutical, before his arrest in 2015. Story
SubjectWell launched a new registry linking people interested in taking part in research with clinical trials for COVID-19 treatments and vaccines. The registry tallied more than 67,000 potential trial participants at the end of May.
UPDATED: Monday, June 15 at 3:30 p.m. ET
Editor's note: This post has been updated to show Trevena provided TRV027 to Imperial College London free of charge.
The U.S. FDA revoked emergency use authorization (EUA) for hydroxychloroquine to treat COVID-19, calling it ineffective and risky for the purpose. The Biomedical Advanced Research and Development Authority (BARDA)—which requested the EUA in March—called on the FDA to cancel the authorization after new data emerged discrediting a now-infamous French study of the drug in coronavirus patients. Story
Imperial College London will target blood clots in clinical trials of TRV027 in hospitalized COVID patients, slated to begin next month. The molecule—developed by Trevena for heart disease and provided to Imperial free of charge—aims to restore balance among the hormones in charge of blood pressure and blood vessels, which become disabled when the virus enters the body.
A coronavirus mutation dubbed D614G could boost the virus' ability to infect cells, according to a Scripps Research study published Friday amid ongoing peer review. Researchers found that D614G increased the number of "spikes" on the virus, which control its ability to replicate, and flagged it as an emerging dominant mutation for further study in controlled trials.
Jolted by its first new surge of COVID infections in weeks, Beijing imposed a fourteen-day at-home quarantine on shoppers and workers linked to the outbreak site—the Xinfadi wholesale food market—and pledged to ramp up testing for the virus.
And as most U.S. regions reopen, states such as Alabama, Arkansas and California have reported record numbers of COVID cases in the past three days, based on a Reuters tally. Part of that jump could stem from increased testing, but many regions are seeing more hospitalizations. too, prompting some officials to threaten a second shutdown if infection rates spike.
Plus, nursing homes across the U.S. are struggling to make-do with shipments of substandard protective gear—if those shipments arrive at all. Story
UPDATED: Monday, June 15 at 9:33 a.m. ET
AstraZeneca struck a €750 million deal with Europe's Inclusive Vaccines Alliance (IVA) to supply up to 400 million doses of its University of Oxford-partnered COVID vaccine, now known as AZD1222, to countries that enroll in the IVA program. AZ aims to deliver the shots to Europe by the end of the year, and has raised its candidate vaccine manufacturing capacity to two billion doses through a series of government contracts and supplier deals.
Meanwhile, Catalent Biologics committed its manufacturing plant in Anagni, Italy to provide vial filling and packaging for AstraZeneca's COVID shot. Catalent will supply hundreds of millions of doses of AZD1222 through March 2022 if the vaccine succeeds in the clinic. Story
Beijing-based Sinovac announced that its inactivated vaccine candidate, CoronaVac, induced neutralizing antibodies in "above 90%" of the 600 people tested during a placebo-controlled phase 2 trial. No side effects were reported, Sinovac said. The vaccine is currently in a separate phase 1 trial, and the company recently made plans to conduct phase 3 trials in Brazil. Story
The German government will invest €300 million ($337.5 million) in the biopharma CureVac, which plans to enter its mRNA-driven COVID shot candidate into clinical testing this month. The state-owned bank, Kreditanstalt für Wiederaufbau, will head the deal and hold around a 23% stake in CureVac. Story
Eli Lilly embarked on phase 3 trials to test its JAK1/JAK2 inhibitor Olumiant (baricitinib) against cytokine storm and viral reproduction in patients with COVID-19. The drug—licensed from Incyte—is approved for rheumatoid arthritis and will be studied in hospitalized COVID patients who show at least one marker of elevated inflammation but do not require invasive ventilation. The phase 3 trial data will complement the NIAID's study of remdesivir alongside baricitinib to treat COVID-19. Story
And Egyptian drugmaker Eva Pharma penned a "landmark" deal with Gilead Sciences to serve as the licensed manufacturer for remdesivir in 127 countries. The Egyptian firm aims to charge around EGP 2,000 ($123.6) per vial once it receives approval from Egypt's health authorities, expected later this week.
UPDATED: Thursday, June 11 at 4:36 p.m. ET
At this year's virtual BIO conference, execs from Merck and Moderna outlined two major hurdles in the race to produce hundreds of millions of COVID vaccines: sourcing raw materials and finding enough people to actually make the shots on such a tight deadline. Story
At that same event, Pfizer said it hadn't given much thought to the return on investment on its COVID vaccine. The "Warp Speed" finalist still needs to sort out manufacturing costs before it can think about price, said chief business officer John Young, who added that Pfizer's top priority was to deliver "vaccines and treatments that the world needs now." Story
Meanwhile, in a note to investors, SVB Leerink analyst Geoffrey Porges defended Gilead's right to profit off the only proven COVID-19 treatment, valuing remdesivir's sticker price at around $5,000 a course—close to the $4,460 cost proposed by drug pricing watchdog the Institute for Clinical and Economic Review. Story
Plus, Sinopharm's inactivated COVID shot, BBIBP-CorV, effectively blocked or reduced coronavirus infection in animal trials, a team of Chinese researchers told the journal Cell. The vaccine induced high levels of neutralizing antibodies against the virus and returned non-detectable viral loads in monkeys who were given higher doses. The shot is currently enrolled in a multi-arm phase 1/2 trial to test its efficacy and safety. Story
Responding to shortages in the COVID test supply chain, plastic bottle maker Coca-Cola Consolidated has inked a deal with the Oak Ridge National Laboratory and the U.S. HHS to produce millions of test tubes used to store coronavirus diagnostics. Story
UPDATED: Thursday, June 11 at 9:29 a.m. ET
Regeneron launched phase 1 trials on its antibody cocktail REGN-COV2 to treat and prevent COVID-19. The placebo-controlled trials will target hospitalized and non-hospitalized COVID patients, plus those without symptoms who've been exposed to the virus. The antibody cocktail binds to SARS-CoV-2's now-notorious spike protein. Regeneron thinks its cocktail treatment could offer a vaccine alternative for the elderly and immunocompromised. Story
Eli Lilly could have an antibody therapy ready to treat COVID-19 by September, the company's chief scientist told Reuters. Both therapies, LY-CoV555—made with Canadian biotech AbCellera—and the Shanghai Junshi-partnered JS016, block the virus' spike proteins that allow it to replicate in human cells. Plus, the company said it has a third, unnamed antibody that could enter human testing in the coming weeks.
Within the month, South Korean biopharma Celltrion Healthcare will start phase 1 trials of its approved arthritis drug, Remsima, on COVID patients in the U.K., company sources told The Korea Herald. Four U.K. health care giants, including University Hospital of Birmingham and the Oxford Biomedical Research Centre, will take part. Researchers think the drug could halt worsening viral pneumonia if given to patients early.
The European Investment Bank (EIB) put up €100 million ($113 million) in debt financing to boost manufacturing of BioNTech's Pfizer-partnered COVID vaccine candidate, BNT162, if it crosses the regulatory finish line. Story
And Moderna has confirmed plans to enroll 30,000 patients in a randomized, placebo-controlled phase 3 study of its COVID shot candidate, mRNA-1273, beginning in July. The company will set phase 3 dosing at 100 micrograms, and said it's still on track to supply upwards of 1 billion doses a year, starting in 2021. Story
Arizona's coronavirus case count has more than doubled since governor Doug Ducey ended business closures and stay-at-home orders in mid-May, prompting congressman Ruben Gallego to pen a call-to-action as the state becomes a new hot spot and hospitals exceed capacity.
Meanwhile, the U.S. has topped 2 million cases and tallied 112,629 deaths from COVID-19. Now, a spokesperson for the National Guard has said that an undisclosed number of troops were infected after responding to widespread protests over the last two weeks. The news comes as officials from the White House's coronavirus task force warn that protests could boost the case count.
UPDATED: Wednesday, June 10 at 3:34 p.m. ET
The National Institutes of Health (NIH) plans to run large phase 3 trials of COVID vaccines from Moderna, AstraZeneca and J&J in the coming months, a government researcher told the Wall Street Journal. Moderna's phase 3 trial is slotted for July, followed by AstraZeneca's in August. Both shots are currently in phase 2 testing. Story
J&J, which had previously said it aimed to start human trials for its coronavirus shot in September, acclerated that timeline Wednesday when it announced plans to start a phase 1/2 study in July. The NIH plans to enroll J&J's shot in phase 3 tests by September.
And amid the COVID vaccine action, WHO updated its list of coronavirus candidate vaccines on Tuesday. Ten of those vaccines are in human trials now, according to WHO, with several new additions to the list coming out of China.
Portable testing company Cue Health will put $100 million in newly raised venture capital toward a scale-up of its San Diego offices and manufacturing sites. The move supports a recent $13 million contract with the Biomedical Advanced Research and Development Authority (BARDA) to rapidly develop a portable, cartridge-based COVID-19 test, which is currently under emergency authorization review by the FDA. Story
Plus, the FDA granted emergency authorization for Illumina's coronavirus test, COVIDseq, designed to sequence the full genome of the virus. The product can process up to 3,000 samples at once, taken from nose and throat swabs, and return results in 24 hours. Story
Ernesto Estrada at the University of Zaragoza in Spain may have found the novel coranvirus' "Achilles' heel" in the protein that drives its reproduction, called main protease (Mpro). In a study published by the journal Chaos, Estrada found that SARS-CoV-2's Mpro was was 1,900% more sensitive to small disturbances than that of the SARS coronavirus, which could make it a valuable target for drugs designed to treat COVID-19. Story
At a panel for the Biotechnology Innovation Organization's virtual meeting, industry leaders discussed ways the COVID-19 pandemic could drive growth in the life sciences. FDA principal deputy commissioner Amy Abernethy talked up the need for increased flexibility at the agency in times of crisis, and others touted the future benefits from partnerships like those forged to tackle COVID-19. AI was another hot topic, as panelists called for more collaboration between tech and pharma. Story
And in a Fortune editorial, Bristol Myers Squibb CEO Giovanni Caforio said he has found "great hope" in the pharma industry's teamwork during the pandemic. He urged companies to continue working together once the crisis is over to better tackle other diseases. Story
UPDATED: Wednesday, June 10 at 9:30 a.m. ET
CEO Albert Bourla said Pfizer won't slap a huge price tag on its COVID vaccine if the shot passes muster in the clinic. The pharma industry has improved its image somewhat as companies battle the novel virus, and while Pfizer has faced criticism in the past for raising prices on its best-selling vaccine Prevnar 13, Bourla said a too-high price tag on the company's COVID shot would be unethical.
Coronavirus vaccine czar Moncef Slaoui, who co-leads the Trump administration's Operation Warp Speed, bailed last-minute on a scheduled appearance to talk about the effort at the Biotechnology Innovation Organization's (BIO) annual conference. His absence comes as "Warp Speed" takes heat for lack of transparency.
China is moving at full speed to create a COVID shot, and plans to boost development of antibody drugs to treat the virus, the country's minister of science and technology, Wang Zhigang, said. China has developed promising inactivated and adenovirus vector vaccine candidates, and will make them globally available if they succeed in the clinic, said Wang.
Panacea Biotech, based in India, forged a deal with Irish biotech Refana to develop an inactivated coronavirus vaccine. Both companies will handle marketing in their respective regions, with Panacea shouldering the bulk of the manufacturing work. The companies aim to churn out 500 million vaccine doses, with more than 40 million expected to be available early next year.
Director of the National Institute of Allergy and Infectious Diseases, Anthony Fauci, called the COVID pandemic his "worst nightmare" at the virtual BIO conference. Fauci said he was confident a vaccine would be developed, but warned that "we're still at the beginning" when it comes to tackling COVID-19.
Once a major hotspot, New York City has seen coronavirus infection rates drop to 1%, down from a massive peak of 71% at the end of March. Those reduced infection rates will be crucial as the city aims for phase 2 of its reopening plan.
Nine U.S. states including Texas, North and South Carolina, California and Oregon have reported some of their highest infection rates since the pandemic began, with many of those cases leading to hospitalization. The numbers may dispel the notion that increased U.S. testing for the virus fueled recent case counts, rather than the virus' spread itself.
More than 2,600 COVID-related lawsuits have been filed this year, according to law firm Hunton Andrews Kurth, prompting the U.S. Chamber of Commerce and business owners alike to lobby Congress for a liability shield.
UPDATED: Tuesday, June 9 at 3:30 p.m. ET
A day after Bloomberg reported on the possible megamerger, sources told The Times of London that AstraZeneca had already lost interest in a tie-up with Gilead Sciences, choosing to focus on its own pipeline and COVID vaccine project instead. Story
GlaxoSmithKline announced plans for midstage testing of one of its antibodies, otilimab, to treat patients hospitalized with severe pulmonary disease from COVID-19. The drug is already in trials for arthritis, and GSK thinks it could help patients hit with cytokine storm—a sometimes-fatal immune response to the virus. Story
Fujifilm plans to pour nearly $928 million into its Denmark-based Diosynth Biotechnologies site, where it will ramp up production of bulk drug substances and complete a massive fill/finish line by 2023. The COVID-19 Therapeutics Accelerator initiative, launched by the Bill & Melinda Gates Foundation, has already claimed manufacturing space at the new plant. Story
Back in April, the National Institutes of Health released trial results from Gilead Sciences showing that its antiviral remdesivir prevented lung disease in monkeys infected with COVID-19. On Tuesday, those results were confirmed in a peer-reviewed publication in the medical journal Nature. Meanwhile, countries have been closely tracking remdesivir's performance in the clinic as they aim to fast-track approval for the drug in COVID patients.
And the technical lead of WHO's COVID-19 response, Dr. Maria Van Kerkhove, walked back comments she made at a Monday briefing that asymptomatic transmission of COVID-19 was rare. Scientists blasted the organization for creating confusion around the virus' spread, which has pushed many countries to require face masks and social distancing even for people who show no symptoms of the illness.
UPDATED: Tuesday, June 9 at 9:27 a.m. ET
The European Medicines Agency (EMA) received Gilead Science's long-awaited marketing application for remdesivir. The EMA will study the drug in patients with COVID-19 on a reduced timeline, and said it has a jump start thanks to a rolling review of data it completed May 15. If Gilead's app passes muster, the EMA will work with the European Commission to rush remdesivir to EU shelves.
And as the world turns to remdesivir as the only proven COVID treatment, a Forbes columnist and former Big Pharma R&D chief said the industry's reputation could sink or swim based on the drug's final cost. Pharma's image has improved as companies work to fight the pandemic, but a high price bar for remdesivir could damage that newfound good faith. Recently, the Institute for Clinical and Economic Review (ICER) valued the treatment at $4,500 per patient.
Japanese drugmaker Daiichi Sankyo penned a deal with the University of Tokyo, Nichi-Iko Pharmaceutical and RIKEN to study and develop a Nafamostat inhalation therapy to treat COVID-19. The drug, approved in Japan for acute pancreatitis and disseminated intravascular coagulation, could prevent SARS-CoV-2 from fusing with host cells, Daiichi research found. The drugmaker expects to start early tests on the treatment next month.
AstraZeneca licensed six promising monoclonal antibodies (mAbs) from Vanderbilt University and plans to advance two of them into clinical trials as a combination therapy by August. The British drugmaker will leverage existing deals with the U.S. government to receive additional funding and manufacturing support.
Plus, Amgen shipped white blood cells from six Icelanders who tested positive for COVID-19 to one of its Canadian labs, where it plans to develop antibody treatments against the virus. The six patients—chosen by Iceland's DeCODE Genetics—showed high levels of COVID-19 antibodies, but were not seriously sickened by the virus.
UPDATED: Monday, June 8 at 3:30 p.m. ET
AstraZeneca eyed Gilead Sciences for a possible tie-up last month, Bloomberg reported, but the U.S. biotech looks unlikely to sell. Gilead shares have climbed about 17% this year on the strength of its drug remdesivir—the only proven COVID-19 treatment. Analysts expect the company to focus on its own deals rather than sign up for a potentially record-setting AZ merger. Story
And with remdesivir cleared for emergency approval in India, South Korea and the U.S. to treat COVID-19, the European Medicines Agency (EMA) said—again—that it would fast-track the drug for use in Europe once Gilead's marketing application is complete.
FDA official Peter Marks "quit in disgust" days after joining Operation Warp Speed over concerns that politics were driving the project, sources told Politico. Marks will resume his role as head of the Center for Biologics Evaluation and Research at the FDA, where he can better resist political pressure, sources said. Story
The Biomedical Advanced Research and Development Authority (BARDA) updated its contract with Moderna to scale up production of the drugmaker's experimental COVID vaccine, mRNA-1273, at additional U.S. manufacturing suites once it exits the clinic. The shot is in phase 2 trials now, and Moderna is working with BARDA and the National Institutes of Health to hammer out plans for phase 3.
Health communications group Evoke Kyne tracked a 65% drop in global conversations about coronavirus from mid-March to late May, which it says might signal consumer readiness to talk about other healthcare topics. Evoke will continue to draw up social plans for pharma companies as conversations around the virus evolve. Story
Meanwhile, privately-owned SiO2 Materials Science penned a $143 million contract with the U.S. Department of Defense and BARDA to ramp up production of vials and syringes used for COVID drugs and vaccines.
Genetics testing company 23andMe published results from a study that showed people with type O blood may be at lower risk of catching COVID-19. Out of 750,000 participants, those with type O blood were 9%-18% less likely to contract the virus, while those who had been exposed were 13%-26% percent less likely to test positive. The study is ongoing and has not been peer-reviewed.
UPDATED: Monday, June 8 at 9:32 a.m. ET
Oxford Biomedica will receive vaccine-making equipment under a new five-year partnership with Britain's Vaccine Manufacturing and Innovation Centre (VMIC) in a move to scale up production on its AstraZeneca-partnered COVID shot, AZD1222.
Shanghai Junshi Biosciences launched an early-stage study in China to test an experimental antibody, JS016 against COVID-19 in infected patients. Junshi said that in addition to treatment, the antibody might help prevent infection in high-risk groups like healthcare workers and the elderly. The catch? The final product would cost much more than a vaccine.
Roche partner Chugai Pharmaceutical Co., surged to the top of the Nikkei 225, overtaking Daiichi Sankyo and Takeda Pharmaceutical as Japan's biggest drugmaker by market value. The pandemic likely spurred those gains: In May, Chugai enrolled patients in a phase 3 trial looking at Roche's arthritis med Actemra to treat COVID-19, and Roche's cancer drugs Tecentriq and Avastin are also being studied in combination against the virus.
And Japan's Fujifilm Holdings said trials on its flu med Avigan to treat COVID-19 could drag on until July. Researchers at Fujifilm have only recruited around 70% of the patients needed for the trial, and results take twenty-eight days to come back. The drugmaker originally aimed to finish clinical trials in June after Japan's prime minister, Shinzo Abe, gave up on getting approval for the med by the end of May.
An official from the U.S. HHS warned that the country's supply of remdesivir—currently the only proven treatment for COVID-19—will run out by the end of June. Gilead gave the HHS a "general range" of doses it hopes to deliver over the summer, but supplies may still fall short of need.
Following a whiplash of retractions and conflicting information, Amit Patel, one of the authors of a now-controversial Lancet study on hydroxychloroquine to treat COVID-19, was fired from his post at the University of Utah.
The New York Times interviewed 511 epidemiologists, gauging professional opinion as restrictions ease and cities around the country push to reopen. Most people interviewed said they would go to in-person doctor visits or engage in limited socialization over the coming months. But most of the epidemiologists agreed on a single point: COVID-19 will affect the way people interact for years to come.
New Zealand lifted all social and economic restrictions except for border controls after announcing it was coronavirus-free on Monday. The country successfully stopped any new transmissions after its last case was reported two weeks earlier, but it will still require people entering the country to be tested and quarantined.
UPDATED: Friday, June 5 at 3:28 p.m. ET
Former FDA chief Scott Gottlieb warned that extra resources going to Operation Warp Speed finalists could limit other drugmakers working on COVID vaccines. Others joined Gottlieb in questioning why vaccine giant Sanofi and Novavax—which both have shots "pretty far along in development," according to the former chief—failed to make the cut, faulting the project's transparency overall. Story
And Novavax—passed over for Operation Warp Speed—inked a $60 million contract with the U.S. Department of Defense (DoD) to help produce components for its vaccine candidate, NVX‑CoV2373. Under the contract, the drugmaker will deliver 10 million doses of the COVID shot to the DoD by the end of the year. Story
On the heels of a manufacturing deal to make COVID vaccines for Moderna, Swiss contract manufacturing organization Lonza has poached Novartis vet and current Roche staffer Pierre-Alain Ruffieux to head up the company as CEO starting November 1. Story
After its HIV drug Kaletra fell short in a COVID trial, AbbVie teamed up with Harbour BioMed, Utrecht University and Erasmus Medical Center to work on a new antibody, 47D11, to treat and prevent the illness, nabbing licensing options along the way. For its part, AbbVie will support ongoing research and future clinical development. Story
The gene-editing technology CRISPR is already used to detect COVID-19 in patients. Now, bioengineers at Stanford University report they've found a way to use CRISPR to disable the virus by scrambling its genetic code. They plan to test their potential therapy—delivered into the lung using synthetic peptides called lipitoids—in animal trials in the U.S. and Sweden. Story
British scientists halted a massive study of hydroxychloroquine, calling the drug "useless" as a treatment for COVID-19 patients. The trial's co-leader, Martin Landray, urged others testing the antimalarial against the virus to follow suit.
In an interview with the Atlantic, nine so-called "long-haulers"—people who have wrestled with COVID-19 symptoms for a month or more—challenged the belief that most coronavirus cases are mild. With much left unknown about the virus, patients with non-debilitating cases report that their long-term symptoms are often met with doubt.
UPDATED: Friday, June 5 at 9:30 a.m. ET
AztraZeneca inked a massive $750 million deal with the Coalition of Epidemic Preparedness Innovations (CEPI) and the vaccine alliance Gavi to churn out 300 million doses of Oxford University's COVID vaccine by the end of 2020. AstraZeneca also forged a licensing agreement with the Serum Institute of India to distribute a billion vaccines to low-income countries, raising total supply caches for the shot to more than two billion per year, the drugmaker said. Story
Heat Biologics, one of the smaller biotechs to try its hand at a COVID vaccine, is advancing development of its coronavirus shot after positive results for its gp96 platform. CEO Jeff Wolf said Heat is aiming for clinical-grade manufacturing by August.
Moderna signed Amgen vet David Meline as the company's new chief financial officer. The regime change comes as Moderna gears up for dual phase 3 vaccine trials—including the drugmaker's COVID-19 vaccine, which recently emerged as an Operation Warp Speed finalist. Now among the frontrunners in the vaccine race, Moderna hopes to boost its commercial capabilities ahead of global demand. Story
Inovio's COVID vaccine efforts hit an unexpected snag when the drugmaker's longtime contract manufacturing partner, VGXI, said it would be unable to make new batches of its shot this year. Now, VGXI is refusing to share its vaccine technology with other manufacturers that could fill the gap. Inovio responded by suing VGXI, claiming it would not be "held hostage."
The Lancet retracted a controversial study discrediting hydroxychloroquine as a COVID-19 treatment. After a week of medical professionals challenging their methods, the study's authors were unable to recreate the results published in the journal's original article. Several countries banned the antimalarial to treat coronavirus patients when the study was first published.
Gilead Sciences is seeking Indian approval for remdesivir “to support the voluntary licensees based in India,” the company said. The biotech previously signed licensing deals with five companies to supply generic remdesivir; four of those are based in India, including Cipla, Hetero Labs, Jubilant Life Sciences and Mylan’s India branch. “The timeline to get remdesivir to Indian patients will depend on the licensees and a process that Gilead does not control,” a Gilead spokesperson said.
India's largest drugmaker, Sun Pharmaceutical, moved the first plant-based treatment for COVID-19 into phase 2 clinical trials. The therapy, AQCH, was initially developed to treat dengue, but has proven effective against COVID in small animal and in-vitro studies, Sun said; the company expects trial results by October.
UPDATED: Thursday, June 4 at 9:30 a.m. ET
Hydroxychloroquine took another hit when the New England Journal of Medicine published a study showing the drug did not fend off infection in those exposed to COVID-19. The trial enrolled patients who had come into contact with the virus, but did not themselves show symptoms. Patients treated with hydroxychloroquine fared 2.4% better than those taking placebo, but that difference wasn't statistically meaningful, the study's authors said. Story
Meanwhile, WHO said it would resume trials on the malaria drug in COVID patients. The organization paused hydroxychloroquine trials last week after the Lancet published a now-contested study questioning its efficacy and safety.
France, Germany, Italy and the Netherlands forged an "inclusive vaccine alliance" aiming to supply COVID shots to Europe. The alliance is in talks with several drugmakers and hopes to bring on the European Commission to ease other EU members into future vaccine-backing initiatives and supply deals.
SVB Leerink upgraded its expectations for remdesivir as more countries pin their hopes on Gilead's antiviral to treat COVID-19. In a note to investors, SVB Leerink said it expects remdesivir sales and government stockpiling to turn a profit—and at a price of about $5,000 per patient in the U.S. Story
The International Council of Nurses pushed countries to release figures on healthcare worker deaths from COVID-19. By the ICN's own calculations, 230,000 healthcare workers have been infected with the novel coronavirus, and more than 600 nurses have died. But reported numbers on healthcare professionals exposed to COVID vary widely around the globe, skewing the total figure, the ICN said.
Mexico surpassed the U.S. in daily COVID deaths for the first time on Wednesday, reporting 1,902 fatalities—more than double its earlier record of 501. The country previously came under fire for lax testing procedures and recently formed a mortality committee in Mexico City to track deaths from the virus.
UPDATED: Wednesday, June 3 at 3:30 p.m. ET
Operation Warp Speed settled on five vaccine finalists Wednesday afternoon, putting AstraZeneca, Merck & Co., Pfizer, Johnson & Johnson and Moderna in line for additional funding, trial assistance and manufacturing help from the federal government. Notably missing were smaller biotechs like Inovio and Novavax. Plus, the high-profile partnership between Sanofi and GlaxoSmithKline was nowhere to be seen. Story
Novavax tapped Japanese contract development and manufacturing organization AGC Biologics to supply immune-boosting adjuvant for its coronavirus vaccine candidate. The tie-up comes two days after the CDMO bought a former AstraZeneca plant in Boulder, Colorada, where it plans to start commercial production by April 2021. Story
Valisure CEO David Light, whose lab helped prompt recent recalls of contaminated meds, pushed for independent testing of all foreign-imported drugs at a Senate Finance Committee hearing Tuesday. Light warned that the FDA, strained by COVID-19, could put more unsafe drugs on U.S. shelves. Story
Contract research organization Covance is rolling out a virtual matchmaking service for COVID-19 trial participants in June. Covance plans to launch COVID-19 Clinical Trial Connect in the U.S., linking people who enroll with clinical studies in their area. Story
The FDA gave a green light to Fitbit's emergency ventilator alternative, FLOW, and granted emergency approval to a second ventilator from NASA's Jet Propulsion Laboratory. Both devices were made in response to shortages of high-end ventilator equipment in U.S. hospitals. Story
On Monday, Beijing prosecutors OK'd the arrest of a former U.S. Biogen staffer accused of hiding her coronavirus symptoms to enter China in March. The employee, surnamed Li, is charged with impairing the prevention of infectious disease. Story
UPDATED: Wednesday, June 3 at 9:30 a.m. ET
Nearly 150 doctors signed an open letter to The Lancet blasting a recent study that undercut hopes for controversial COVID treatment hydroxychloroquine. The Lancet's study was not a prospective clinical trial, relying instead on healthcare data to draw conclusions. Several government trials for the malaria drug were put on pause after the results were published.
South Korea granted emergency approval for Gilead Science's remdesivir on Wednesday, joining a host of countries looking to bring the antiviral to COVID patients. South Korea's Ministry for Food and Drug Safety approved five daily doses for moderately ill patients and 10 days of treatment for patients on oxygen support.
German drugmaker Stada Arzneimittel set its sights on China, taking steps to secure API supplies and increase its presence in Asia's largest pharmaceutical market in light of the pandemic. The company recently signed traditional Chinese medicine maker Shijiazhuang Yiling Pharmaceutical to produce cough syrup in the region, and has two more deals with mainland firms in the works.
King's College London launched a new trial to determine whether ibuprofen might be repurposed to help patients with COVID-19.
The Lonza Group, recruited by Moderna to manufacture COVID vaccines, says it could complete two of its commercial manufacturing lines ahead of schedule. Lonza hopes to supply small batches of active ingredients for Moderna's experimental vaccine by July, and announced its Portsmouth, New Hampshire and Visp, Switzerland lines should be ready to make ingredients by the end of the year—a month ahead of projections.
NIAID director Anthony Fauci said the phase 3 trial for Moderna's experimental COVID-19 vaccine will begin in July. The tests will mainly take place in the U.S., focusing on a wide range of patient ages, but Fauci added the company also plans to enroll 30,000 patients in trials abroad.
And as protests over George Floyd's death roiled the country, coronavirus testing sites from Florida to California were forced to close or reduce hours over safety concerns.
UPDATED: Tuesday, June 2 at 2:30 p.m. ET
Convalescent plasma is the latest potential treatment for COVID-19 to emerge successfully from phase 1 trials, according to new data published by the Houston Methodist Medical Center. Seventy-six percent of patients who received plasma therapy showed improvement with no adverse side effects reported.
Tom Lynch, three months into his tenure as Fred Hutchinson Cancer Research Center chief, says its prior virology work puts Hutch in an ideal position to help track the novel coronavirus, develop tests, create trials and more. The center has already launched studies to track the virus on its own campus and nearby, and plans to open a COVID-19 clinical research center later this summer. Story
Indian drugmakers are eager for government approval to start making remdesivir under license from Gilead Sciences, but pricing and dosage are two major holdups.
In an interview with CNBC, Ken Frazier said the U.S. is now facing two storms—protests over police brutality and the COVID-19 pandemic. The Merck & Co. CEO stressed that no one person could rebuild the country alone, and asked people to come together during the dual crises. Story
Pfizer launched a new podcast focused on the developing COVID-19 pandemic Monday. Part of the company's larger Antigen series, the podcast will focus on vaccine development updates, past epidemics and more. Story
Faulting a broken pharma supply chain that pushes production offshore, White House trade adviser Peter Navarro called for increased drug manufacturing in Puerto Rico. Drugmakers have pulled out of the U.S. territory in recent years as tax codes changed and utility costs rose, but it could play a role in rebuilding domestic supply lines.
Britain refused to support a WHO initiative that would have pooled coronavirus research and encouraged the country to produce any final medicines patent-free. U.K.-based drugmakers AstraZeneca and GlaxoSmithKline had also refused to join the initiative.
Bret Giroir said he would step down from his post as coronavirus testing czar in mid-June, after several weeks working with FEMA to expand COVID testing capacity.
Alabama, South Carolina and Virginia all reported a 35% or greater increase in new COVID infections during the week ended May 31, according to an analysis by Reuters. Even as all fifty states begin some form of phased reopening, the CDC has recommended they wait for daily counts of new infections to fall for fourteen days before easing social distancing.
UPDATED: Tuesday, June 2 at 9:30 a.m. ET
After working behind the scenes for several months, Merck & Co. made a splash last week when it announced it had cut deals to develop two coronavirus vaccines and an antiviral drug. The vaccines—one bought along with Themis and the other in collaboration with IAVI—are expected to enter clinical trials this summer, while its Ridgeback Therapeutics-partnered antiviral is currently in phase 1 studies. Though slow to start, Merck stressed in a BioPharma Dive interview that it's playing the long game, focusing on treatments and vaccines that are widely available rather than directed toward the most vulnerable or severely ill patients.
Vas Narasimhan, CEO of Swiss drug giant Novartis, laid out vaccine development facts in an interview with Fortune. Unlike medications meant for sick patients—which come with some expected side effects—a vaccine must clear an extraordinary safety bar for use in a healthy population. So when will a COVID-19 vaccine hit the market? Narasimhan puts the timeline closer to two years, a ways out from Operation Warp Speed's January goal.
China-based I-MAB Biopharma turned in positive results from a phase 1 study on its experimental COVID-19 treatment, TJM2 last week. Now, the company is preparing to push the antibody into phase 2 as drugmakers rush to bring coronavirus treatments to market. TJM2 joins several drugs positioned to treat cytokine storm—a potentially fatal immune reaction in patients with COVID-19. Story
FDA Commissioner Stephen Hahn said the agency will permanently apply some of the lessons it has learned during the COVID-19 pandemic. Many of those changes would put the FDA in a better position to respond to future public health crises, he said. In particular, Hahn pointed to the importance of telemedicine, lab-related testing and providing support to decentralized clinical trials. Story
Zoloft prescriptions jumped 12% to 4.9 million in March as people coped with isolation and pandemic anxiety. This was followed by another 4.5 million prescriptions in April, straining supplies—and prompting the FDA to add the antidepressant to its list of drugs in shortage because of COVID-19. Zoloft's branded manufacturer, Pfizer, makes its own ingredients, but said 100-mg tablets are in short supply. Meanwhile, Lupin, which sells a generic version, told the FDA it lacks active ingredients to meet demand. Story
Phased reopening hasn't led to an uptick in COVID-19 cases yet, but the long weekend may have boosted the numbers some, according to Bernstein analyst Ronny Gal. Both Florida and Texas saw a recent spike in infections and deaths from the virus, but Gal attributed this to the recent holiday, noting the overall seven-day trend stayed mostly flat.
UPDATED: Monday, June 1 at 3:30 p.m. ET
BARDA has updated a 2012 contract with Emergent Biosolutions that secures the drugmaker's Baltimore Bayview facility to produce COVID-19 vaccine candidates through 2021. The Bayview facility was created in 2012 with the Department of Health and Human Services and designed to rapidly turn out vaccines and treatments during public health emergencies. The company won $628 million under the deal. The task order also granted Emergent $85.5 million to expand its viral and non-viral drug manufacturing capacity. Story
Canadian biotech Resverlogix announced plans to evaluate its BET inhibitor apabetalone—first approved for cardiovascular indications—as an effective COVID-19 treatment. The drug's safety was previously confirmed in phase 3 clinical trials in patients with cardiovascular disease, and the company has started a new preclinical study to see whether the drug stymies replication of the coronavirus in human cells.
After operating in stealth mode for months, Patrick Soon-Shiong, CEO of NantKwest and privately held ImmunityBio, announced Friday that his companies had penned an agreement with the Department of Health and Human Services (HHS) to test an experimental COVID-19 vaccine in monkeys. So far, HHS has remained silent about the deal.
When Bristol Myers Squibb first nabbed Celgene's long-sought FDA nod for multiple sclerosis drug Zeposia in March, the company held back its launch due to COVID-19. Monday, Zeposia officially hit the market. So what changed? Two months later, as parts of the country reopen and others have set up telemedicine, BMS feels it can now deliver Zeposia to patients effectively.
The Word Health Organization (WHO) bit back after an Italian doctor suggested that the novel coronavirus has lost its potency. The Italian health ministry urged its citizens to "maintain maximum caution," and the WHO warned, "this is still a killer virus." Meanwhile, countries around the world have started to plan phased reopenings.
Anthony Fauci, M.D., director of the National Institute for Allergy and Infectious Diseases, voiced confidence in Operation Warp Speed's vaccine manufacturing timetable during a wide-ranging interview with Stat. Whether those vaccines would be effective was another matter.
Over fears of another COVID-19 spike, Hong Kong police issued a formal ban on this week's vigil for the Tiananmen Square massacre—a somber, yet expected move as the government extended its ban on public gatherings in groups larger than eight until June 4. Amnesty International has urged officials to create a socially distanced vigil rather than ban it.
UPDATED: Monday, June 1 at 9:33 p.m. ET
Eli Lilly started phase 1 trials of its AbCellera-partnered antibody, LY-CoV555, entering testing ahead of schedule and before other drugmakers in the antibody hunt. The delivery of safety data from its phase 1 trial could mark the start of a multifront R&D program at Lilly. Story
Gilead Sciences released top-line data from its phase 3 Simple trial for remdesivir in COVID-19 patients with pneumonia, but without reduced oxygen levels. Patients who took a 5-day course of remdesivir were 65% more likely to show signs of clinical improvement compared with patients who received standard care, the company said. Story
Could COVID-19 be a vascular disease? The Lancet explored the idea in a three-patient analysis that found traces of the virus in endothelial cells. The virus is known to infect ACE2 receptors in the lungs, but the study shone new light on its ability to spread to other organs and cause potentially fatal inflammation. The results provided further rationale for treating COVID patients with anti-inflammatory drugs, the analysis said.
AstraZeneca CEO Pascal Soriot, among others in the COVID-19 vaccine race, floated the possibility that drugmakers may need to relocate trials to harder-hit countries, such as Brazil, as infection rates fall in Europe and the U.S.
The Chinese government said on social media that the country could have a coronavirus vaccine ready for market by the end of the year. Vaccines from the Wuhan Institute of Biological Products and the Beijing Institute of Biological Products recently entered phase 2 clinical trials, with the Beijing Institute expected to produce up to 120 million doses a year.
The Russian Direct Investment Fund, together with the ChemRar Group, said they plan to provide the experimental COVID-19 treatment Avifavir—a knockoff of Fujifilm Holdings' Avigan—to hospitals across the country starting June 11.
Brazil and the U.S. struck a COVID-19 deal Sunday. According to a White House statement, the U.S. has delivered 2 million doses of the controversial drug hydroxychloroquine to Brazil, and now plans to ship 1,000 ventilators as well. The two countries are planning joint clinical trials as well.
As cities across the U.S. protested against police brutality this past weekend, health officials warned that crowded demonstrations could cause a resurgence in COVID-19 infections. Former FDA commissioner Scott Gottlieb said Sunday that Minnesota, the epicenter of the protests, had already experienced an uptick in cases.
UPDATED: Friday, May 29 at 3:30 p.m. ET
Vaccine executives from AstraZeneca, GlaxoSmithKline, Johnson & Johnson and Pfizer tuned in virtually to discuss the pharma industry's response to COVID-19 at this year's International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) event. They dwelled on a common theme: Companies need to cooperate, not compete, if they hope to deliver vaccines on a global scale. Story
U.S. hospitals are cutting back on hydroxychloroquine as a potential COVID-19 treatment. Northwell Health, New York's largest healthcare system, stopped prescribing the drug in mid-April, and Seattle's University of Washington hospitals removed it from their latest treatment guidelines. France became the first country to ban hydroxychloroquine to treat the virus earlier this week.
With the world looking to remdesivir as the only proven COVID-19 treatment so far, the European Medicines Agency pledged to review it for approval as quickly as possible. One holdup? The EMA is still waiting on Gilead Sciences' application.
New Zealand is down to one active COVID-19 case following a seven-day streak without new infections. The announcement came Friday as the country eased restrictions in the wake of a highly successful campaign to halt the virus' spread.
And in the U.S., coronavirus infection rates have dropped in many hard-hit regions. But the pandemic may be entering a new phase, experts warned. As former hot spots like New York City and New Jersey prepare for phased reopenings, infections and deaths are on the rise in rural parts of the country. Meanwhile, outbreaks have spiked in the Middle East and South America.
Brazil's business capital, São Paulo, will start reopening on Monday, despite record levels of daily coronavirus infections in the country. Brazil confirmed more than 438,000 cases as of Friday, and for the third consecutive day, its tally of official COVID-19 deaths topped 1,000. Just under a quarter of those fatalities came from São Paulo.
UPDATED: Friday, May 29 at 9:05 a.m. ET
Novartis jumped back into vaccine making Thursday as the company inked a manufacturing deal with Massachusetts General Hospital and Massachusetts Eye and Ear, which aim to use the Swiss drugmaker's gene therapy technology to develop a COVID-19 shot.
The Swiss drug maker's gene therapy unit, AveXis, will spearhead production, parlaying expertise used to produce the gene therapy Zolgensma. Phase 1 trials for the vaccine are slated to begin in the second half of 2020. Manufacturing players Viralgen, Aldevron, and Catalent also signed on to help produce the vaccine.
One unexpected hiccup in the COVID-19 vaccine hunt? Finding enough glass vials to store the vaccine. Now, AstraZeneca, Johnson & Johnson and Pfizer are exploring the possibility of storing multiple doses in a single vial to save supplies.
Amid recent concerns that a COVID-19 vaccine may take longer than expected to develop, Pfizer CEO Albert Bourla said the company could have a vaccine ready around the end of October. Bourla claimed the challenges were "daunting," however, amid glass vial shortages and dropping transmission rates that could stymie clinical trials.
I-Mab Biopharma released promising results from a phase 1 clinical trial investigating its antibody TJM2's ability to lower inflammatory cytokine levels in patients with COVID-19. A data monitoring committee confirmed that the antibody was tolerable and safe in patients, prompting I-Mab to proceed with phase 2 testing.
Mumbai-based BDR Pharmaceuticals put in a bid with India's drug controller to produce and sell a generic version of Gilead's remdesivir. Meanwhile, Gilead Sciences has forged voluntary licensing agreements with Cipla, Hetero Labs and others to sell the antiviral in 127 low and middle-income nations, including India.
A resurgence of COVID-19 cases in Seoul prompted South Korean officials to request imports of Gilead's antiviral treatment, remdesivir. The country's Ministry of Food and Drug Safety must approve the import first, but a government panel is satisfied with remdesivir's performance, the director of South Korea's Centers for Disease Control and Prevention said.
Jakarta-based Kalbe Farma penned an agreement with the South Korean biotech Genexine to begin a clinical trial of a COVID-19 vaccine candidate in Indonesia. The candidate, GX-19, was developed by a consortium of biotech companies, and has been tested on primates so far.
Game Doctor, a Glasgow-based tech company, scored £50,000 from the U.K. government to develop a smartphone game that will teach children about drug and vaccine development. The app will gather analytics on how players' views about COVID-19 change during gameplay.
UPDATED: Thursday, May 28 at 3:55 p.m. ET
Nonprofit watchdog Public Citizen, along with the Lower Drug Prices Now coalition, asked the Inspector General and Office of Government Ethics to reclassify Dr. Moncef Slaoui as a special government employee, which would require him to abide by federal conflict of interest rules. Slaoui—appointed to head up the administration's vaccine-accleration project, Operation Warp Speed—has faced criticism for his ties to pharmaceutical companies. He recently resigned from Moderna's board and sold off his shares in the company, but his other financial ties may be less well known, Public Citizen said.
A survey from the Harris Poll shows pharma's reputation has improved in the U.S., and the industry's response to COVID-19 is what changed many Americans' minds. Opinions warmed among young respondents and urban dweller, with 40% of Americans reporting a more positive view of the industry since the pandemic began. Among the 16% who developed more negative feelings, many said they believed the industry had put company interests ahead of public needs during the COVID-19 crisis. Story
Belgium faced criticism last month when it counted suspected COVID-19 deaths alongside those confirmed through testing. Now, France, the U.K., New York State, and others are following Belgium's lead as concerns grow that deaths from the virus are being grossly underreported.
Senator Tim Kaine and his wife, Anne, tested positive for coronavirus antibodies. In a statement Thursday, Kaine said he had experienced flu-like symptoms earlier in the year, but did not receive a coronavirus test due to shortages at the time. He returned to the Senate floor in May, joining Rand Paul as the second senator to test positive for the virus.
New data from the Centers for Disease Control and Prevention show more than 60,000 COVID-19 infections among healthcare workers and close to 300 deaths. But those numbers may be low, according to National Nurses United, which has placed the death count closer to 530. Meanwhile, U.S. hospitals continue to push for stable supplies of personal protective equipment and more effective safety guidelines as they grapple with the virus.
UPDATED: Thursday, May 28 at 9:48 a.m. ET
Oxford Biomedica penned a one-year clinical and commercial supply deal with AstraZeneca to scale up manufacturing for the COVID-19 vaccine candidate AZD1222. AstraZeneca will gain access to Oxford Biomedica's Oxbox manufacturing center under the deal, and Oxford will provide AstraZeneca with multiple batches of the vaccine throughout 2020. Story
A former president of Merck & Co.'s vaccine division, Gordon Douglas, echoed concerns that a COVID-19 vaccine may not be ready by the end of this year. Eighteen months may be more realistic, but Douglas said that would still be "a very optimistic forecast." The good news? Companies may be more motivated to develop antivirals in the meantime.
Roche announced a new partnership with Gilead as the drugmakers started a phase III study testing the Swiss drugmaker's immunology med Actemra/RoActemra alongside Gilead's antiviral remdesivir to treat COVID-19. Roche plans to begin enrollment in June, with a target of 450 patients globally. Story
The president and CEO of oncology biotech Immunomedics, Harout Semerjian, resigned from his post Wednesday, citing COVID-19 "logistical obstacles." Semerjian will take more than $1 million in severance pay with him, along with several perks, including 18 months of continued health coverage. Story
GlaxoSmithKline has pledged to ramp up production of its vaccine-boosting adjuvant in 2021 to supply companies racing to develop COVID-19 shots. The Big Pharma said it's in talks with governments to help fund the capacity boost, with plans to start production at European and North American sites. GSK has yet to reveal the program's cost, but said that making the adjuvanted vaccines available to the world's poorest populations is key. Story
Moderna expanded a 2016 deal with Swiss pharmaceutical ingredient maker CordenPharma on Thursday to secure large quantities of lipids for its experimental COVID-19 vaccine mRNA-1273. The deal grants access to two additional CordenPharma manufacturing sites in France and the U.S. as Moderna looks to boost its vaccine stores in anticipation of success in the clinic.
UPDATED: Wednesday, May 27 at 9:30 a.m. ET
As the World Health Organization halts testing on hydroxychloroquine to treat COVID-19, France has become the first country to effectively ban the drug for such use.
Novavax paid $167 million in cash to acquire Praha Vaccines, landing the company a biologics manufacturing facility in the Czech Republic that is expected to supply more than 1 billion doses of antigen beginning in 2021 for the company's NVX-CoV2373 vaccine candidate. Novavax also announced that it will collaborate with the Serum Institute of India to increase manufacturing capacity by the end of 2020. Story
With new COVID-19 cases in decline across many major cities, vaccine makers are faced with a perverse dilemma: Fewer people are getting sick, making it harder to judge the efficacy of vaccines. To keep development on track, vaccine companies will likely turn to volunteers at higher risk of exposure to the virus.
Senate Majority Leader Mitch McConnell said Congress would likely pass another coronavirus stimulus bill in the coming weeks, stressing, “we need to make sure we have unemployment insurance properly funded for as long as we need.” Meanwhile, Americans are filing unemployment claims at record levels.
Countries could face another coronavirus peak ahead of a presumed second wave if they scale back restrictions too soon, the World Health Organization warned. The advisory comes as crowds across the U.S. flouted social distancing measures over Memorial Day weekend.
A Census Bureau survey cited in The Washington Post revealed the toll that coronavirus has taken on Americans’ mental health. Twenty-four percent of respondents showed signs of a major depressive disorder after three months sheltering in place, with symptoms more frequent among young people, women and low-income individuals. White House press secretary Kayleigh McEnany suggested that long-term closure of the economy could be to blame.
Doctors are concerned that patients displaying severe symptoms of COVID-19 don’t always test positive for the virus. As studies show that the virus may replicate deeper in the respiratory system of seriously ill patients, swab tests have come under fire for mixed results, including the Abbott quick test used at the White House.
UPDATED: Tuesday, May 26 at 10:45 a.m. ET
Merck has struck a deal to buy Themis to accelerate development of a COVID-19 vaccine. The takeover will see Merck, a latecomer to the response to SARS-CoV-2, apply its vaccine capabilities to a candidate based on Themis’ measles vector platform that is set to enter the clinic this year.
The Big Pharma also plans to leverage previous work on its Ebola Zaire vaccine, Ervebo, as it partners with nonprofit IAVI to advance a COVID-19 vaccine. The investigational rVSV vaccine platform will be engineered by IAVI scientists in Brooklyn while Merck spearheads clinical development.
Merck also announced a partnership with Ridgeback Biotherapeutics to develop EIDD-2801, an oral antiviral candidate to treat patients with COVID-19. Story
The World Health Organization is putting a stop to global studies into the effectiveness of hydroxychloroquine after repeated safety concerns. The decision came following a study published in The Lancet that showed patients who took hydroxychloroquine were at higher risk of death and heart problems than those who did not.
Gilead's remdesivir has shown promising results, but some limits, too. Detailed data published in the New England Journal of Medicine showed that on average, hospitalized patients receiving remdesivir recovered a median of four days faster than patients on placebo, with mortality in the remdesivir group at 7.1% compared to the placebo group's 11.9%. But the data also suggest the drug offers more benefits to patients on oxygen therapy than to the critically ill on mechanical ventilators. Story
Novovax enrolled the first participants in a phase 1/2 clinical trial of its coronavirus vaccine candidate NVX-CoV2373 and said it expects the first results by July. The company said it plans to produce up to 100 million vaccine doses this year and more than 1 billion in 2021.
Across the U.S., states have failed to meet the White House’s 14-day deadline to test all nursing home residents and staff for coronavirus. Many have called the logistics and costs unrealistic. Only a few states, including Rhode Island and West Virginia, have met the deadline, with others still scrambling to put together a plan for widespread testing.
Oxford University's Adrian Hill warned that data from AstraZeneca's experimental coronavirus vaccine trial has a 50% chance of proving useless as social distancing does its work. Successful containment efforts have reduced the number of participants infected with the virus, prompting Hill to backpedal on earlier projections of an 80% shot at an effective vaccine by September. Story
Ahead of Memorial Day festivities, the FDA Commissioner Stephen Hahn tweeted a reminder that the COVID-19 pandemic “is not yet contained.” Other health experts, who warned that failure to social distance could stymie the gradual reopening of the country, echoed Hahn’s call for caution.
UPDATED: Friday, May 22 at 10:22 a.m. ET
Top pharma executives from Sanofi, Eli Lilly, and Cipla expressed concerns that governments will cut funding after the current crisis dies down and that they will struggle to develop or manufacture potential drugs and vaccines for COVID-19 and future outbreaks.
Although the Unversity of Oxford has yet to share phase 1 data from its AstraZeneca-partnered COVID-19 vaccine AZD1222, researchers there have already begun enrolling subjects in a phase 2/3 clinical trial, aiming to recruit 10,260 people in the U.K. and generate results to support the first deliveries in September. Story
AstraZeneca just nabbed more than $1 billion from the U.S. government to develop and produce the vaccine candidate. In an interview with CNN, CEO Pascal Soriot said the big bet is "absolutely worth it."
Meanwhile, the U.K.’s Vaccines Manufacturing and Innovation Centre just got a £131 million financial boost from the U.K. government so it can come online earlier to help make COVID-19 vaccines. Story
The lead researcher in a clinical trial of Fujifilm's Avigan said it's still too early to tell whether the flu drug works in COVID-19. Despite recent media reports that it didn't provide clear efficacy in blocking the virus at an interim analysis, Yohei Doi, who's leading the study at Fujita Health University, said the study will continue.
The U.S. medical community is calling for the release of detailed clinical data on Gilead Sciences' remdesivir so doctors can direct limited supplies to the right patients.
The Trump administration recently signed little-known Phlow to make generic medicine and active pharmaceutical ingredients in Virginia. As Bernstein analyst Ronny Gal sees it, large generics players will probably also start to move their manufacturing to the American soil. Story
How did Phlow win that $354 million Biomedical Advanced Research and Development Authority contract? It started more than a year ago, according to Martin VanTrieste, CEO of Civica Rx, one of the companies that will work with Phlow to create a stockpile. Story
Amarin said it's supporting a clinical trial that tests the effects of its fish-oil-derived heart drug Vascepa on inflammatory biomarkers and other patient outcomes in COVID-19.
Scientists at the Johns Hopkins University School of Medicine are running a clinical trial of alpha blocker to find out whether the commonly used drug can stop the esclation of hyperinflammation in patients not on a ventilator or in intensive care.
Abbott Laboratories said an analysis of data from an ongoing study of its ID NOW rapid point-of-care COVID-19 test, which is used in the White House and elsewhere, shows it's nearly 95% accurate. New York University researchers previously said the test could be missing a third to nearly half of positive cases.
Fitbit is launching a study to determine whether its watches can detect COVID-19 even before noticeable symptoms such as fever and cough show up.
UPDATED: Thursday, May 21 at 9:36 a.m. ET
Following the U.K. government, BARDA is awarding AstraZeneca more than $1 billion to supply the University of Oxford’s vaccine candidate. The British drugmaker is also in talks with international organizations and potential partners, including India's Serum Insitute, to increase production and access.
China's CanSino Bio is already testing a recombinant coronavirus vaccine in China, but it’s jumping on the mRNA vaccine bandwagon through a licensing deal with Precision NanoSystems. Story
Moderna is currently the leader in the mRNA vaccine space, but Evercore ISI analyst Umer Raffat is raising doubts about the strength of preliminary phase 1 data the biotech recently posted. Story
AstraZeneca previously invested in Moderna. Now, its 7.7% stake in the mRNA specialist is worth more than $2 billion.
Meanwhile, Inovio said its DNA vaccine candidate elicited strong neutralizing antibody and T-cell responses in mice and guinea pigs. Data from an ongoing phase 1 test is expected in June.
GSK Consumer Healthcare has partnered with Mammoth Biosciences to develop a hand-held, at-home COVID-19 test based on the latter's CRISPR platform. The final product is said to have the potential to deliver point-of-use results in less than 20 minutes.
Apple and Google are rolling out a software toolkit that can be used to quickly notify people if they’ve had close contact with a person diagnosed with COVID-19. Story
Roche has launched its Elecsys Anti-SARS-CoV-2 antibody test at more than 20 U.S. sites, with plans to increase to more than 200 commercial and hospital lab sites in the next several weeks and the ability to perform millions of tests per week.
Michael Ryan, the WHO’s emergencies chief, said hydroxychloroquine—which President Donald Trump has endorsed and said that he‘s taking—should only be used in controlled clinical trials before its utility in COVID-19 is confirmed.
UPDATED: Wednesday, May 20 at 8:45 a.m. ET
Roche is already running a clinical trial dubbed COVACTA testing Actemra's ability at controlling severe immune overreaction in hospitalized COVID-19 patients. Earlier this month, the company's Genentech unit has launched a new trial of the IL-6 inhibitor at hospitals that largely treat underserved and minority patient populations. The study, coded EMPACTA, has dosed its first patient on May 14 in New York with the aim to enroll about 375 patients.
Data reported to Japan’s health ministry by hospitals treating patients with mild or no symptoms found Fujifilm's Avigan offered no clear benefits, Kyodo reported, citing people familiar with the matter. Japanese Prime Minister Shinzo Abe has said he is hoping to approve the flu drug for COVID-19 by the end of May.
Early in the outbreak, Pfizer CEO Albert Bourla knew medical solutions for COVID-19 would be needed, according to a Forbes article on the company's response. He directed the company's scientists to work as quickly as possible on a vaccine, putting $1 billion on the line.
During a cabinet meeting on Tuesday, President Donald Trump called a study that had found no benefit from hydroxychloroquine in a group of veterans a "phony study" and claimed it was done by "obviously not friends of the administration" who wanted to "make political points."
Patrick Soon-Shiong's NantKwest has won FDA clearance to test its mesenchymal stem cell treatments in severe COVID-19 patients with acute respiratory distress syndrome and cytokine storm.
Meanwhile, despite strong opposition from the health community, Brazilian President Jair Bolsonaro is poised to loosen protocols around the use of chloroquine for mild coronavirus cases. He has ordered the military to ramp up production of the drug.
People with Type 1 diabetes are three and a half times more likely to die than non-diabetics who catch COVID-19 while Type 2 patients are twice as likely to die than non-diabetics, NHS England has found.
UPDATED: Tuesday, May 19 at 2:52 p.m. ET
Covis Pharma, a biopharma company headquartered in Luxembourg, has started a phase 3 trial of its Alvesco inhaler in non-hospitalized COVID-19 patients 12 and older. The placebo-controlled study will recruit 400 patients at multiple sites in the U.S.
After President Donald Trump said he has been taking hydroxychloroquine to prevent against COVID-19, Vice President Mike Pence said he's not on the drug, Fox News' Kristin Fisher reports.
More from the VP on why he is not taking Hydroxychloroquine:— Kristin Fisher (@KristinFisher) May 19, 2020
“My physician hasn’t recommended that, but I wouldn’t hesitate” to take it if he did recommend it.
And lots more on the big @NASA @SpaceX launch next week coming soon
A retrospective data analysis from UnitedHealth and the Yale School of Medicine found that older COVID-19 patients with hypertension on ACE inhibitors had a significantly lower risk of hospitalization, prompting the need for further research.
UPDATED: Tuesday, May 19 at 10:32 a.m. ET
Gilead Sciences has pledged to donate its current supply of 1.5 million doses of remdesivir, of which 607,000 vials are being allocated to the U.S. government. Now, the biotech is increasing its U.S. donation to about 940,000 doses by June.
Before the donated supply runs out in June or early July, Gilead is preparing to pivot to a commercial model and start charging for remdesivir in the second half of the year, SVB Leerink analyst Geoffrey Porges wrote to clients after talking to senior management. The company also envisages remdesivir becoming a "multi-year commercial opportunity," he said.
Meanwhile, Cipla, which is one of four drugmakers with nonexclusive remdesivir licensing deals, is also looking at combo treatment options for COVID-19, including teaming Fujifilm's flu drug Avigan (favipiravir) with the Gilead med.
AstraZeneca has an ongoing collaboration to help manufacture a vaccine candidate by the University of Oxford, with funding from the U.K. government. The British drugmaker is in talks with other organizations and governments to strike similar deals. Story
Moncef Slaoui, the newly appointed U.S. coronavirus czar, will divest his $10 million in Moderna stock options, which shot up in value Monday after the company unveiled promising early data.
The Trump administration has signed a $354 million four-year deal with with a new Virginia company called Phlow to produce generic drugs and APIs needed to treat COVID-19 in an effort to bring pharma manufacturing back to the U.S., The New York Times reported. The contract, awarded by the Biomedical Advanced Research and Development Authority, may be extended for a total of $812 million over 10 years.
Canada has allowed China's CanSino Bio to begin clinical testing of its adenovirus-based COVID-19 vaccine, currently the most advanced program in any part of the world.
The U.S. CDC plans a nationwide antibody study of up to 325,000 people to track how the novel coronavirus spreads, according to Reuters.
President Donald Trump is threatening to make his "temporary freeze of United States funding to the World Health Organization permanent and reconsider our membership in the organization" if the group doesn't take on the reforms he's proposed over its links to China.
UPDATED: Monday, May 18 at 3:41 p.m. ET
Moderna shares leapt as the company unveiled early phase 1 data showing its vaccine candidate, mRNA-1273, elicited neutralizing antibodies in eight trial participants available for analysis. Based on the data, The company said its own phase 2 trial will be amended to study two dose levels, 50 µg and 100 µg. Story
Meanwhile, CureVac is ramping up its own vaccine research efforts, and has rolled out preclinical results ahead of a planned phase 1/2a study next month. Story
Verily launched a new clinical research effort focused on COVID-19, with an initial focus on coronavirus antibody testing. Run through its Project Baseline initiative, the program will also recruit healthy individuals to gauge the wider impact of the disease on mental health, lifestyle and more. Story
Fitbit plans to leverage its supply chain to start building its own COVID-19 ventilator, and hopes to submit its designs to the FDA in the near future. The prototype device includes more features than the typical emergency alternatives, but is designed to be cheaper than the more durable hospital devices. Story
The FDA authorized an at-home sample collection kit from Everlywell that works with multiple coronavirus diagnostic tests. Story
Teva walked away from negotiations with federal prosecutors, daring the U.S. Department of Justice to pursue criminal price-fixing charges against the drugmaker at a time when it's part of the COVID-19 pandemic response. Story
Microsoft and UnitedHealth Group launched a simple smartphone app for digitally screening employees based on reported COVID-19 symptoms, to help clear those who can return to work. Story
AstraZeneca aims to answer questions that COPD and asthma patients may have when it comes to COVID-19, through an unbranded TV ad and a company YouTube channel with tips on navigating exercise, grocery shopping and telemedicine. Story
UPDATED: Monday, May 18 at 9:22 a.m. ET
On the heels of Moncef Slaoui's appointment as the leader of Trump administration's COVID-19 vaccine accelerator, Operation Warp Speed, the former GlaxoSmithKline exec has resigned from Moderna's board. But he still holds stock options worth $10 million in the biotech, which has received federal funding for its mRNA project. Calling it a "huge conflict of interest," Sen. Elizabeth Warren called on Saloui to "divest immediately."
It is a huge conflict of interest for the White House’s new vaccine czar to own $10 million of stock in a company receiving government funding to develop a COVID-19 vaccine. Dr. Slaoui should divest immediately. https://t.co/8IWLxVL7la— Elizabeth Warren (@SenWarren) May 15, 2020
Moderna shares leapt Monday as the company unveiled early phase 1 data showing its vaccine candidate, mRNA-1273, elicited neutralizing antibodies in eight trial participants available for analysis. Based on the data, The company said its own phase 2 trial will be amended to study two dose levels, 50 µg and 100 µg.
The EU could grant Gilead's remdesivir an conditional nod in the "coming days," EMA head Guido Rasi said on Monday at a hearing at the EU Parliament in Brussels.
The Seattle Coronavirus Assessment Network (SCAN), which has won support from the Bill & Melinda Gates foundation, said it's suspending its at-home COVID-19 test after the FDA tightened guidelines to require emergency approval first. “The FDA has not raised any concerns regarding the safety and accuracy of SCAN’s test, but we have been asked to pause testing until we receive that additional authorization,” the organization said.
Indian drugmakers have managed to increase manufacturing capacity to around 50% to 60% even as lockdowns in key areas of the country continue. Shipping and congestion at ports remain major hurdles to supply.
The Chinese government is pushing back against the Trump administration's accusations around its response to the coronavirus, floating its own theory of the pathogen's origin.
The U.S. Navy says 13 sailors from the USS Theodore Roosevelt who had recovered from the coronavirus with clear negative test results have now tested positive again.
UPDATED: Friday, May 15 at 3:05 p.m. ET
In a Rose Garden address soon after his appointment as the head of the Trump administration's project "Warp Speed" to accelerate a COVID-19 vaccine, former GSK exec Moncef Slaoui said data from an unnamed vaccine "made me feel even more confident that we will be able to deliver a few hundred million doses of vaccine by the end of 2020." Slaoui has been a board member at Moderna, which is developing an mRNA vaccine for COVID-19; he has left the board now that he has accepted the new post. Story
Manufacturing specialist Univercells has inked a new deal to provide prefabricated vaccine development facilities to help speed the production of potential COVID-19 shots. Story
The FDA has issued another umbrella-style Emergency Use Authorization, covering infusion pumps, devices and accessories that are in high demand for treating patients with COVID-19. Story
The U.S. government is aiming to stockpile doses of promising COVID-19 vaccines to have hundreds of millions of doses ready to go if any pass regulatory scrutiny, Department of Health and Human Services Secretary Alex Azar told Fox News.
An Oxford University professor developing a potential COVID-19 vaccine told Reuters that the shot "won't be expensive." Oxford has plans to commercialize its vaccine with AstraZeneca.
UPDATED: Friday, May 15 at 9:23 a.m. ET
Sanofi CEO Paul Hudson's comment that the U.S. "has the right to the largest pre-order" of its COVID-19 vaccine drew a backlash from French President Emmanuel Macron and Prime Minister Edouard Philippe. So the French pharma's chairman, Serge Weinberg, intervened, promising no country would get priority.
The NIH is adding a new regimen to its ACTG clinical programs. This time, it will test hydroxychloroquine—which has won public endorsement from President Donald Trump—alongside the antibiotic azithromycin in a phase 2b trial that will enroll approximately 2,000 mild-to-moderate patients. Teva will supply the antimalaria drug for the study for free.
China now has five potential COVID-19 vaccines in clinical testing, with an aggregate 2,036 volunteers already dosed at the phase 2 stage, Zeng Yixin, vice minister of China's National Health Commission, said at a press briefing Friday.
After a preliminary study by researchers at NYU Langone Health found Abbott's rapid, point-of-care coronavirus test could miss nearly half of positive cases, the company said it would change its instructions for the ID Now device to tell users that negative results are "presumptive" and should be verified with an alternative test for patients with signs of the virus.
A research team at the Institut Pasteur Korea suggested that pancreatitis drug nafamostat appears to be much more effective than remdesivir. Previously, a team at the University of Tokyo found the drug could effectively block the viral entry process of the new coronavirus. A clinical trial of the drug started in April, according to clinicaltrials.gov.
Despite the urgent need to develop COVID-19 vaccines and treatments, big investment firms are not enthusiastic about putting down the bets. Why? Such a drug might not result in big profits for shareholders. “We are all cheering for a treatment on a humanitarian level, but as an investor, you have to believe a treatment works, and that sales last long enough for it to have a material impact on a company,” Larry Robbins, who runs health-care hedge fund Glenview Capital Management, told The Wall Street Journal.
UPDATED: Thursday, May 14 at 2:45 p.m. ET
A new study measuring the performance of Abbott’s rapid, point-of-care coronavirus test found the device could miss nearly half of positive cases, depending on how the samples were handled and fed into the machine. Conducted by researchers at NYU Langone Health, the study has not yet been peer-reviewed. Story
The FDA is working with the Centers for Disease Control and Prevention to develop a "phased approach" to restarting on-site drug manufacturing facility inspections, which have been halted since March. Story
The National Institutes of Health launched a new study of generic antimalarial hydroxychloroquine and antibiotic azithromycin with mild to moderate COVID-19. That drug combination once touted by President Donald J. Trump has been met with mixed clinical results.
A novel coronavirus vaccine being developed by researchers at Oxford University has passed a small-scale primate study, Reuters reported. Oxford recently reached a deal with British drugmaker AstraZeneca to commercialize the vaccine, which the university said could be ready for human patients by the end of the year.
Russian drugmaker Chemrahr said it was testing generic antiviral Avigan in phase 2 and 3 trials based on criteria from the World Health Organization, Reuters reported. The drug secured $2 million in funding from the Russian Direct Investment Fund.
The BMJ warned that a “deluge of poor quality research [in COVID-19] is sabotaging an effective evidence-based response,” while Nature argued that more patients are needed for better trial results. Story
UPDATED: Thursday, May 14 at 10:05 a.m. ET
Shortly after Sanofi CEO Paul Hudson suggested his company would offer the first batches of a potential COVID-19 vaccine to the U.S. because the country stepped up with early funding, Agnes Pannier-Runacher, France’s deputy finance minister, slammed such "privileged access" as "unacceptable."
The Trump administration is reportedly planning to appoint Moncef Slaoui, formerly head of GlaxoSmithKline's vaccines business, as the leader of "Operation Warp Speed," an initiative aimed at accelerating the development of a COVID-19 vaccine. Slaoui currently holds a board seat at Moderna, which is working on an mRNA vaccine candidate.
In a new guideline, the American College of Physicians says current evidence does not support the use of the antimalarial drugs chloroquine or hydroxychloroquine, either alone or in combination with azithromycin, to prevent or treat COVID-19.
Meanwhile, Novartis CEO Vas Narasimhan, who led the Swiss drugmaker's vaccine development efforts during the 2009 H1N1 pandemic, said a COVID-19 vaccine may only become available in the second half of next year.
Marco Cavaleri, the EMA’s head of vaccines, also said a vaccine could be approved in about a year in an “optimistic” scenario.
Speaking of vaccines, Greenlight Biosciences, which is developing mRNA vaccine candidates, has raised $17 million to scale up its production capacity targeting the production of billions of doses of COVID-19 vaccine.
Netherlands biotech Intravacc said it has developed three COVID-19 vaccine concepts based on its outer membrane vesicle technology.
Influential journals The BMJ and Nature have come forward with warnings that COVID-19 research, while urgently needed, should still maintain high quality. They pointed out that many clinical trials on potential treatments are poorly designed and yield no meaningful results. Story
After a fast-tracked approval, Japan has already started distributing Gilead Sciences' remdesivir to hospitals. The drug is being used for patients in intensive care or on ventilators.
Takeda has committed to donating JPY 2.5 billion ($23 million) across three United Nations-led organizations to support the UN COVID-19 Global Humanitarian Response Plan.
Exyte and Univercells Technologies have formed a partnership for optimized construction of modular standardized and flexible GMP manufacturing facilities for vaccines in response to potential global demand for COVID-19 vaccines upon approval.
UPDATED: Wednesday, May 13 at 3:15 p.m. ET
Because the U.S. stepped up first to invest in the company’s research, Sanofi CEO Paul Hudson told Bloomberg the country “has the right to the largest pre-order" of the drugmaker's potential COVID-19 vaccine.In fact, the government expects to be rewarded with quick access, Hudson says, after BARDA signed on in February to collaborate with the French drugmaker. Story
Thermo Fisher Scientific is developing its own COVID-19 antibody test through an ongoing, three-way collaboration with WuXi Diagnostics and the Mayo Clinic, and plans to seek international authorizations for the test over the next few weeks. Story
The FDA authorized devices and algorithms from Philips, Eko and Caption Health to diagnose patients with preexisting cardiovascular diseases have a higher risk of dying from COVID-19. The devices are also, in part, designed to help limit healthcare providers’ exposure to the disease. Story
Russia suspended the use of Aventa-M ventilators after some of the devices were linked to fatal fires, Reuters reported. Some of those unites were sent to the U.S. in April but were not needed for use, officials said.
UPDATED: Wednesday, May 13 at 8:58 a.m. ET
Even if Moderna succeeds with its unproven vaccine platform, the biotech won't be able to make enough doses for the entire world, CEO Stephane Bancel said. He's hoping several vaccine makers make it to the finish line to share the load.
Celltrion secured funding from the Korean government to advance MERS and COVID-19 pipeline medicines.
Hackers from China and Iran have been targeting American companies and researchers working on COVID-19 drugs and vaccines since early January, officials say.
After Gilead inked a series of licensing deals for remdesivir, Public Citizen argued the drug should be in the public domain. The company's current approach picks "winners and losers," the group said.
Some of former BARDA director Rick Bright's colleagues say his whistleblower complaint left out some key details, Politico reports.
Researchers at the Washington University School of Medicine are testing the antidepressant fluvoxamine for its potential to help prevent immune system overreactions in COVID-19 patients.
A team in Denmark is studying whether sickle cell anemia medicine senicapoc could help reduce lung damage from COVID-19.
Authorities in Japan are allowing pharmaceutical companies to bypass certain requirements to seek regulatory approval for potential COVID-19 medicines, including Fujifilm's Avigan.
With many small, independent COVID-19 studies taking place around the world, an editorial in Nature argued for more scientific collaboration.
The U.K. government unveiled a plan to sequence genes of 35,000 COVID-19 patients in an effort to learn more about the virus and discover treatments.
After dozens of cases of pediatric multisystem inflammatory syndrome in New York City, healthcare systems are ramping up a testing effort for children.
UPDATED: Tuesday, May 12 at 2:53 p.m. ET
Gilead inked licensing deals with generic drugmakers Cipla, Ferozsons Laboratories, Hetero Labs, Jubilant Lifesciences and Mylan allowing those companies to manufacture and distribute remdesivir in 127 countries, royalty-free.
With at least eight COVID-19 vaccines in human testing, NIAID director Anthony Fauci said he's "cautiously optimistic" one or more could work. Story
India-based Glenmark Glenmark is starting a phase 3 study of favipiravir, the generic of Fujifilm's Avigan, in COVID-19 patients in its home country.
Deaths from delays in routine medical care due to lockdowns could rival the toll from COVID-19, experts wrote in the Wall Street Journal.
UPDATED: Tuesday, May 12 at 9:01 a.m. ET
At a Senate hearing today, NIAID director Anthony Fauci plans to warn of "needless suffering and death" if the U.S. reopens too soon, the New York Times reports. The heads of the CDC and FDA will also testify at the hearing.
The European Medicines Agency expanded its compassionate use guidelines for Gilead's remdesivir. Originally, the drug was recommended for patients requiring mechanical ventilation. It's now recommended for certain hospitalized patients.
After ramped-up ventilator supplies helped forestall feared shortages—and the tough decisions physicians might have had to make in allocating them—didn't materialize, doctors are now worried about having to ration remdesivir due to supply constraints, CNN reports.
In a retrospective study of more than 1,400 people in New York, treatment with hydroxychloroquine, azithromycin, or both, did not improve survival rates for hospitalized patients.
The FDA added two medicines that used to put patients onto ventilators to its list of drug shortages.
John Burkhardt, Pfizer's site leader at an R&D facility in Groton, Connecticut, told local newspaper The Day he believes "science will win" in the fight against the pandemic. The company is exploring numerous approaches to fight the virus.
Early in the remdesivir rollout, the U.S. made mistakes with initial shipments, Coronavirus Task Force member Dr. Deborah Birx acknowledged in an email to colleagues covered by the Wall Street Journal.
There was "unanimity within the institute" that NIAID should stop its placebo-controlled remdesivir study early based on positive effects from the drug, an official told Stat. Gilead's remdesivir has won an emergency use authorization from the FDA based on the trial data.
The FDA updated COVID-19 therapy guidelines in an effort to help drugmakers speed up their regulatory submissions.
UPDATED: Monday, May 11 at 3:35 p.m. ET
Two White House staffers have tested positive for COVID-19, and FDA Commissioner Stephen Hahn, NIAID Director Anthony Fauci and CDC Director Robert Redfield are placing themselves into partial or full quarantines for two weeks. Story
Wearing masks in the White House is now mandatory, according to ABC News, following a new policy instituted Monday afternoon. Additionally, Hahn, Fauci and Redfield will testify before the House of Representatives via teleconference this week, regarding ways to reopen the economy.
Meanwhile, the FDA authorized its first COVID-19 antigen test, bringing a new category of diagnostic against the disease. Similar to the rapid, swab-based tests used for the flu, antigen tests detect unique protein fragments found on the outer walls of the novel coronavirus. Quidel’s Sofia 2 test kit is designed for the point-of-care, such as in hospitals, urgent care clinics, doctor’s offices and elsewhere. Story
The agency also gave a new diagnostic green light allowing a saliva-based coronavirus test to be used at home, letting people mail in their own samples for analysis. The authorization expands the use of the spit test developed at Rutgers University. Story
To gear up for a manufacturing blitz that may see hundreds of millions of vaccine doses, Pfizer is trading off resources slated for its existing medications. The Big Pharma plans to outsource the production of some of its portfolio to its 200-strong network of contractors. Story
Elsewhere, Immunomedics raised $459 million in a stock offering to help launch its first-in-class Trodelvy therapy in triple-negative breast cancer—as the pandemic impacts efforts for the new antibody-drug conjugate. Story
As various countries rush to develop vaccines and treatments, the FBI and the Department of Homeland Security are preparing to issue a warning that hackers tied to the Chinese government are trying to steal "valuable intellectual property" about vaccines, treatments and testing "through illicit means." Story
What's it like to work on a coronavirus vaccine? For J&J immunologist and discovery team leader Rinke Bos, it's social distancing in the lab, remote work and late nights at home. Story
Charles River Labs revised its year-long guidance, warning of “a significant impact on the research models and services revenue growth rate” in this year’s second quarter. The CRO expects the COVID-19 pandemic to reduce 2020 revenue by about $135 to $215 million. Story
Twitter announced that it would label specific tweets containing disinformation about the pandemic. While the warnings won't provide active fact-checking, they may direct users to more-curated information.
UPDATED: Monday, May 11 at 9:10 a.m. ET
Physicians and hospitals have already expressed frustrations about the difficulty obtaining Gilead Sciences' remdesivir. Now, an HHS distribution plan shows that only 607,000 vials of the emergency use drug will be made available to U.S. patients over the next six weeks, out of a total donation of about 1.5 million. RBC Capital analyst Brian Abrahams said that supply is likely "significantly constrained" given the current infection rate.
And amid the chaotic rollout of remdesivir, former FDA commissioner Scott Gottlieb said on CBS News that the government needs a "better system" for distributing coronavirus therapeutics.
Meanwhile, Regeneron CEO Len Schleifer told CNN that he's worried the U.S. doesn't have enough capacity to manufacture potential COVID-19 treatments or vaccines.
Elias Zerhouni, who was NIH director under former President George W. Bush before a seven-year stint with Sanofi’s research business, is leading a narrowing pack for the position of COVID-19 czar. HHS Secretary Alex Azar “personally prefers Zerhouni for the role,” one person familiar with the matter told Politico. Story
Pfizer is in talks to transfer more of its drug production to outside contractors, including Catalent, Lonza and Thermo Fisher, Mike McDermott, president of global supply at Pfizer, told Reuters. The New York pharma is making the moves as it prepares for large-scale production of its BioNTech-partnered experimental COVID-19 vaccine.
Zydus Cadila has been tapped by the Indian government for mass production of the country’s first homegrown ELISA-based SARS-CoV-2 antibody test kit, which was developed by the National Institute of Virology. The test is said to be able to handle 90 samples in a single run of 2.5 hours.
Israeli company RedHill Biopharma has won FDA clearance to run a clinical trial of its drug opaganib in 40 patients with moderate to severe COVID-19. The drug previously showed early promise in a small group of Israeli patients.
UPDATED: Friday, May 8 at 3:20 p.m. ET
Gilead Sciences may have been the target of Iranian hackers using fake email login pages to access confidential data, Reuters reported. In one case, a fake login page was sent to a legal and corporate affairs executive in April. Reuters couldn't confirm whether the attack was successful.
Speaking of Gilead, the National Institutes of Health will pair the drugmaker's COVID-19 antiviral remdesivir with Eli Lilly's rheumatoid arthritis drug Olumiant in a new study in U.S. hospitalized patients. The trial will eventually enroll 1,000 patients across 100 sites, the NIH said.
The FDA published results from the first batch of COVID-19 antibody diagnostics to have their accuracy independently evaluated by federal laboratories—starting with 12 blood tests the agency had already authorized for emergency use against the pandemic. Story
One of the antibody tests, from Abbott Laboratories, was found to be extremely effective in detecting whether individuals previously had COVID-19. The Washington School of Medicine reported in the Journal of Clinical Microbiology that Abbott's test had a specificity of 99.9% and a sensitivity of 100%, suggesting very few false positives and no false negatives, Reuters reported.
Global Blood Therapeutics' sickle cell disease medicine Oxbryta got off to a hot start after a November FDA approval. But early in its launch, execs now say they're seeing a "clear headwind" from the COVID-19 pandemic. Story
UPDATED: Friday, May 8 at 9:00 a.m. ET
Hydroxychloroquine has failed an observational study in New York. According to a paper published in The New England Journal of Medicine, researchers found no significant difference between hydroxychloroquine and standard care in terms of patients' need for ventilation or death rate. But the team does stress that additional randomized clinical trials are needed.
After the FDA's emergency use authorization, Gilead donated its entire stockpile of remdesivir to the government for further distribution. But the drug hasn't reached those most in need, according to Axios. "Some went to the wrong places, some went to the right places," one senior Trump administration official said. "We don't know who gave the order. And no one is claiming responsibility."
Teva has confirmed its full-year revenue guidance of between $16.6 billion and $17 billion. While some of its generics and over-the-counter products got a sales boost during the pandemic, sales of others, such as migraine drug Ajovy, slowed. “Depending on how long these situations last … these things work in a way for us where they more or less balance each other off,” CEO Kåre Schultz told Barron's.
Shionogi said it plans to begin clinical trials of its coronavirus vaccine by the end of the year, expecting to launch it as early as fall 2021.
Meanwhile, Chinese vaccine maker Sinovac is talking to foreign regulators and the World Health Organization to launch phase 3 clinical trials of its inactivated vaccine outside of China, CEO Yin Weidong told Bloomberg.
Sorrento Therapeutics has teamed up with Mount Sinai Health System to develop an antibody cocktail that binds to three different epitopes of the novel coronavirus' spike protein. Story
India's Cadila Pharmaceuticals has shut down its formulations manufacturing plant in Ahmedabad, India, after 26 employees tested positive for the new coronavirus. And 95 employees who may have come in contact with the infected workers have been quarantined. Story
UPDATED: Thursday, May 7 at 3:10 p.m. ET
Endo International withdrew its 2020 guidance due to COVID-19 uncertainties. The company expects the pandemic to affect an upcoming launch, plus patient recruitment and site selection for new and ongoing clinical studies.
Sareptha Therapeutics' Vyondys 53 rollout in Duchenne muscular dystrophy hit a snag as doctors were unable to administer patients' initial doses before they transition to home infusions, RBC Capital Markets analysts wrote in a note to clients. The company's net sales of $100 million during the first quarter missed expectations.
Alynlam lowered its 2020 revenue guidance for Onpattro by 5% due to the pandemic and is taking "thoughtful" steps to cut costs.
UPDATED: Thursday, May 7 at 8:20 a.m. ET
Gilead Sciences' remdesivir won approval in Japan as Veklury. It's the first full global nod for the COVID-19 treatment following the U.S. emergency use authorization last week. Authorities in Japan approved the drug under an "exceptional approval" regulatory pathway.
Meanwhile, Gilead spent about $50 million on remdesivir manufacturing scale-up and clinical trial costs during the first quarter, the biotech said in its quarterly securities filing. It also warned of possible COVID-19-related delays with the FDA's review of its application for JAK inhibitor filgotinib in rheumatoid arthritis.
And now, as Gilead works to increase supplies after last month's FDA emergency authorization, many U.S. hospitals are still having a hard time getting the drug for their patients. "There are people who are getting diagnosed right now who qualify for treatment and don't have access to it," an infectious disease and critical care physician at the University of Virginia told Business Insider.
Moderna is planning an "imminent" start to a 600-participant phase 2 trial of its mRNA vaccine candidate, mRNA-1273, after the FDA cleared its trial protocol. The company's goal is to initiate a phase 3 study "early this summer" and win approval as soon as 2021, CEO Stéphane Bancel said. Story
GlaxoSmithKline has identified its investigational anti-GM-CSF antibody otilimab—already in trials for arthritis—as a potential treatment for severe inflammatory symptoms in hospitalized patients with COVID-19. The company expects to start a midstage trial in the coming weeks. Story
Pfizer, in its collaboration with BioNTech, will mass produce its COVID-19 vaccine at three sites if it's proven efficacious. Its Andover, Massachusetts, site will be used for drug substance manufacturing, while a site in St. Louis will be used for critical raw material manufacturing. Another in Kalamazoo, Michigan, will handle formulation and fill. Story
The NIH will test a plasma-derived hyperimmune globulin therapy by an alliance formed by Takeda, CSL Behring and others. The global clinical trial is expected to start in the summer and will form the foundation for potential regulatory approvals, Takeda said.
Despite a strong first quarter, CRO giant PPD has pulled its full-year guidance after “some customers have delayed new studies and/or paused ongoing studies or certain activities in ongoing studies, such as patient recruitment, patient enrollment, site visits and site monitoring.” Story
In a change of course, President Donald Trump now says the U.S. coronavirus task force will continue indefinitely rather than winding down as he had previously said.
The task force will be “very focused” on the development of a coronavirus vaccine and treatments, the president said, and he promised to announce "two or three new members to the task force" as soon as Monday. Many healthcare providers and public health officials say they are still lacking protective equipment and have far fewer diagnostic tests than they need.
....gloves, gowns etc. are now plentiful. The last four Governors teleconference calls have been conclusively strong. Because of this success, the Task Force will continue on indefinitely with its focus on SAFETY & OPENING UP OUR COUNTRY AGAIN. We may add or subtract people ....— Donald J. Trump (@realDonaldTrump) May 6, 2020
Scientists are now questioning the findings in a recent study that claims a more transmissible form of the novel coronavirus has emerged and has been spreading in Europe since early February, according to The Atlantic.
UPDATED: Wednesday, May 6 at 3:20 p.m. ET
Gilead Sciences says it’s in licensing talks with the “world’s leading chemical and pharmaceutical manufacturing companies” about their ability to produce remdesivir for countries in Europe, Asia and beyond until at least 2022. Story
Eli Lilly has agreed to pay $10 million upfront and committed up to $245 million for ex-China rights to co-develop and sell neutralizing antibodies from China’s Junshi Biosciences to fight COVID-19. The pair aims to apply to start a clinical trial in the U.S. in the second quarter. Story
Medical device association AdvaMed launched a new online platform to put ventilator manufacturers in touch with potential suppliers of much-needed components, as more companies across a variety of industries pivot their resources toward the novel coronavirus pandemic. Story
Sidelined by the novel coronavirus pandemic, Team Novo Nordisk, a professional cycling team sponsored by the drugmaker, has taken to Twitter, Instagram, Facebook and LinkedIn with news, interviews, training tips, throwbacks to past races, contests (#GuessTheRider) and general encouragement for diabetes patients. Story
UPDATED: Wednesday, May 6 at 9:15 a.m. ET
Sanofi, in collaboration with GlaxoSmithKline, aims to start a phase 1/2 study of their vaccine in September, with a goal of enrolling hundreds of subjects, John Shiver, Sanofi Pasteur's vaccine R&D chief, said. Late-stage trials with thousands of subjects are expected to take place by year-end or early 2021, he told Reuters.
Roche's phase 3 trial of Actemra has enrolled half of its planned 330 patients, Genentech CEO Alexander Hardy said in an interview with the Neue Zuercher Zeitung, according to Reuters. "We’ll be finished in May or June," he added.
Meanwhile, Roche CEO Severin Schwan told ABC News that the Swiss pharma is meeting aggressive production targets with its antibody test and will be able to produce 60 million tests by the end of May. He said the engagment and commitment from employees are "really enormous."
Gilead Sciences' remdesvir could be approved in Japan Thursday right after the health ministry's review board meets that day, Japanese Health Minister Katsunobu Kato said.
CSL Behring said it will begin onshore development of a plasma-based SARS-CoV-2 plasma product immediately. The product will concentrate antibodies from plasma donated by Australian people who have recovered from the disease. The CSL unit is part of a global plasma therapy alliance with Takeda and others. Story
Biotech CEOs from Cadent Therapeutics, 28-7, Surface Oncology and others mostly in the Boston area have joined a forum that gathers for a weekly call to exchange ideas for managing the COVID-19 crisis, The Wall Street Journal reported.
Scientists have identified a new strain of the coronavirus that appears to be more contagious than the early versions in the pandemic, according to a new study led by scientists at Los Alamos National Laboratory.
UPDATED: Tuesday, May 5 at 3:13 p.m. ET
Rick Bright, former head of the HHS' BARDA unit, filed a complaint alleging his transfer away from his position was retaliation for his criticism of the Trump administration's COVID-19 response. Story
Meanwhile, the White House is planning to wind down the coronavirus task force "in the coming weeks," the New York Times reports.
Immigration and Customs Enforcement is working with companies such as Pfizer and Amazon to crack down on counterfeit medical gear and COVID-19 tests, the Wall Street Journal reports.
UPDATED: Tuesday, May 5 at 8:55 a.m. ET
Pfizer and partner BioNTech started human testing for their mRNA vaccine program in the U.S. shortly after starting trial enrollment in Germany.
A drugmaker in Bangladesh, Beximco, plans to start making Gilead's newly FDA-authorized remdesivir for $59 to $71 per vial, Reuters reports. The company is planning to produce the drug for domestic use, at least initially. It isn't clear whether Beximco had a licensing deal to manufacture the product.
One aspiration for Johnson & Johnson's manufacturing deal with Emergent BioSolutions was to have the potential vaccine produced stateside, the New York Times reports. The R&D work, partially funded by BARDA, is taking place at a J&J lab in the Netherlands.
Amid scientific progress for COVID-19 drugs, tests and vaccines, experts still believe vaccine timelines are overly optimistic, CNBC reports.
Among other gatherings, Biogen's Boston meeting in late February played a "notable" role in the early COVID-19 outbreak in the U.S., a top CDC official said. The management confab spawned cases in several states and overseas.
NIAID chief Anthony Fauci told National Geographic there's no evidence the novel coronavirus was manipulated in a lab. Trump administration officials have been ramping up their criticism of the Chinese government's handling of the outbreak.
As states around the country start to reopen their economies, the influential IHME model from the University of Washington dramatically raised its COVID-19 death projection to more than 134,000 by August 4. And the New York Times obtained a CDC document that shows a projection for about 3,000 daily deaths by early June, nearly double the current level.
Drug companies are testing dozens of existing drugs against COVID-19, and now a supercomputer says hepatitis C drugs might hold promise, Economic Times reports.
As lawmakers look into the Trump administration's pandemic response, the administration has barred task force members from appearing at Congressional hearings during the month of May, the Wall Street Journal reports.
China already has four companies testing potential COVID-19 vaccines in humans, but as the New York Times points out, the country's vaccine industry has suffered scandals in recent years.
UPDATED: Monday, May 4 at 3:25 p.m. ET
How much should Gilead Sciences charge for remdesivir? Up to $4,460 per patient, according to the Institute for Clinical and Economic Review. But even at $1,000 per patient—less than a quarter of ICER's pitched price—Gilead could theoretically rake in $1 billion in sales, as it looks to build a supply capable of treating 1 million patients by the end of the year. Story
And now that remdesivir has the FDA’s blessing, analysts are already turning to what’s next—with some saying the antiviral is just the first of several drugs expected to treat COVID-19. Others may include convalescent plasma and concentrated antibody therapies, which may carry stronger benefits, but face supply challenges. Story
Alnylam and Vir Biotechnology identified an inhaled RNAi treatment for COVID-19, and are aiming to begin human testing before the end of the year. Their collaborative efforts launched in early March, after Alnylam synthesized 350 siRNAs targeting the SARS-CoV-2 genome, and Vir signed up to assess the antiviral activity of the most promising prospects. Story
Shortly after scoring an emergency authorization for its COVID-19 antibody diagnostic, Roche said it would invest $459 million into a German manufacturing facility to help meet its goals of producing tens of millions of tests per month. Story
The CDC launched a wide-ranging nationwide consortium—including dozens of state and federal labs, the private sector, academia, and non-profits—to coordinate future whole genome sequencing efforts aimed at the novel coronavirus. Public data from the SPHERES project will be used in COVID-19 surveillance and biomedical research. Story
UPDATED: Monday, May 4 at 9:30 a.m. ET
Gilead's closely-watched remdesivir has secured an FDA emergency use authorization. In the agency's approval letter, FDA chief scientist Denise Hinton said the lethal nature of COVID-19 and the lack of approved treatments, plus the drug's promising clinical data, mean that the drug's potential benefits outweigh potential risks. Story
Eli Lilly is shelling out $10 million up front and committing $245 million in potential milestone payments to license ex-China rights to Junshi Biosciences' neutralizing antibody candidate, JS016, according to a disclosure (PDF) to the Hong Kong Stock Exchange. The Chinese biotech is co-developing the therapy with the Institute of Microbiology of the Chinese Academy of Sciences. Lilly and Junshi expect to enter clinical studies in the U.S. in the second quarter.
Besides, Lilly also has an antibody deal with AbCellera, which is now entitled to receive up to $175.6 million from the government of Canada to support drug R&D efforts against COVID-19 as well as future pandemic threats. Story
The FDA has granted an emergency nod to Roche's antibody test. The company said it has already begun shipping the Elecsys diagnostic kits and plans to ramp up production to the “high double-digit millions per month” in May for the U.S. market and abroad. Story
Alkermes is accepting applications for its COVID-19 Relief Fund, promising to provide up to $500,000 in grants to assist nonprofit organizations in their work to help address COVID-19-related needs for people living with addiction, serious mental illness or cancer.
NASA has applied its space-based skills on Earth, having received an FDA emergency authorization for VITAL (Ventilator Intervention Technology Accessible Locallyits), a ventilator designed for the pandemic. Story
Meanwhile, U.S. weapons makers have teamed up with medical device companies to increase the supply of ventilators, Reuters reported. As part of a wider collaboration, the Aerospace Industries Association teamed with U.S. medical device trade association AdvaMed to create a marketplace where ventilator makers post requests to defense companies to help meet surging demand.
The European Union warned that suspension of childhood vaccination during the coronavirus epidemic could cause serious problems, Reuters reported.
President Donald Trump now says he believes the U.S. death toll from the pandemic could reach as many as 100,000. But he said he's confident a vaccine would be developed by year-end.
UPDATED: Friday, May 1 at 3 p.m. ET
The mechanism of action Roche's IL-6 inhibitor Actemra, which has posted early effective data in treating cytokine storm in severe COVID-19 patients, may be tied to the activation of T-cell counts in patients' blood, a new study found. Story
The National Institutes of Health kicked off what it describes as a “Shark Tank”-like effort to select and fund new diagnostic tests for the novel coronavirus, and its offering a total of $1.5 billion to be divvied up among the winners. Story
Citron Research has come out against Inovio, labeling the biotech's COVID-19 vaccine claims as Theranos-like, the medtech company that promised to deliver answers and diagnoses for many diseases through a simple blood test but turned out to be a sham. The firm's attack claimed that Inovio developed a vaccine in just three hours “under the same scientific team that has spent decades deceiving investors.” Story
Complications from the novel coronavirus pandemic have sent the cost of transporting drugs up 224%, according to a new survey from a generics industry trade association. Story
Federal prosecutors have launched a probe into the communications of Vladimir "Zav" Zelenko, a doctor who has discussed the efficacy of antimalarial hydroxychloroquine with the White House, the Washington Post reported. The probe began after Jerome Corsi, long attached to former Trump associate Roger Stone, accidentally emailed communications to a federal prosecutor rather than Zelenko.
UPDATED: Friday, May 1 at 9:30 a.m. ET
The NIH's National Institute of Allergy and Infectious Diseases is already running separate studies on Gilead Sciences' antiviral remdeisivr and Eli Lilly's anti-inflammatory drug Olumiant. Now, the institution is planning to combine the two drugs in another study, Gilead said during a presentation on Thursday. The exact trial design, including the number of patients to be enrolled, is unclear, but Gilead said the study will "start soon."
During the presentation, Gilead CEO Daniel O'Day said recent remdesivir data coming out of NIAID could serve as a benchmark for future drug development efforts. The results "changes the landscape for drug development within COVID-19 in that one has to now think about comparing to remdesivir and/or looking at adding to remdesivir," he said. Story
Meanwhile, investors are more interested in knowing whether or when remdesivir can make money. When pressed by analysts on the Thursday conference call about a commercial plan, O'Day said, "we just don’t have the answers yet." So far, the biotech has earmarked its entire supply through this summer, prioritizing clinical trials and compassionate use programs. Story
To speed up its evaluation, the European Medicines Agency started a rolling review of remdesivir, though the agency has yet to commit to a timetable. Japanese Prime Minister Shinzo Abe previously said remdesivir will enjoy a fast-track review in his country as soon as Gilead files an application. Story
Amgen will test its newly-acquired blockbuster psoriasis med Otezla as a potential COVID-19 treatment, joining several other companies studying whether a drug's anti-inflammatory traits can fight the new disease. Amgen bought Otezla from Celgene in a $13.4 billion deal late last year as part of Celgene's merger with Bristol Myers Squibb.
Moderna Therapeutics has tapped Lonza to help manufacture the biotech's mRNA vaccine candidate, dubbed mRNA-1273. The agreement will initially bring suites online at Lonza facilities in the U.S. and Switzerland, with batch production expected to start at the U.S. site as early as July. If everything goes as planned, Moderna could have the capacity to produce one billion doses a year. Story
The FDA published guidance for the industry on exemptions from certain requirements of the Drug Supply Chain Security Act during the pandemic. Some activities such as tracing drugs through distribution channels are waived when a product is for emergency use.
The U.S. Intelligence Community, which is made up of several government intelligence agencies, has concluded that the novel coronavirus was not man-made or genetically modified in a lab. The agencies "will continue to rigorously examine emerging information and intelligence to determine whether the outbreak began through contact with infected animals or if it was the result of an accident at a laboratory in Wuhan,” it added.
Hologic is launching a second COVID-19 test that can dramatically expand diagnostic capabilities in the U.S. The company will distribute three million tests to around 1,000 hospitals and public health labs starting from next week.
UPDATED: Thursday, April 30 at 3 p.m. ET
Fujifilm Diosynth Biotechnologies has set aside space at its Denmark biologics facility for a to-be-determined COVID-19 treatment identified through the Bill Gates-funded therapeutics accelerator. The deal sets aside an unspecified production volume for 2021 with options for the following years, Fujifilm said. Story
The Trump administration is working up a Manhattan Project-style joint initiative dubbed "Operation Warp Speed" to bring biotech, pharma and federal agencies together to speed up the hunt for a COVID-19 vaccine. The project's goal is delivering 100 million doses of a viable COVID-19 vaccine by the end of the year, which would be a radical acceleration of the typical vaccine development timeline, which is typically described in years, not months. Story
Seeking to explain why new, positive data on Gilead Sciences' remdesivir were released at a White House press briefing rather than through normal channels, Anthony Fauci, M.D., director of the National Institutes of Health, told Reuters the move was intended to preempt leaks that could confuse the narrative. Story
Scientists from the University of Texas at Austin, the National Institutes of Health, and Ghent University in Belgium developed a treatment that links two nanobodies isolated from a llama to create an antibody that binds to the spike protein on the coronavirus that causes COVID-19. Story
Riding a sales wave for triple combo cystic fibrosis drug Trikafta, Vertex is one of the rare drugmakers upping its sales forecast despite operational hits from the novel coronavirus pandemic. The drugmaker said it grew 77% on the quarter. Story
UPDATED: Thursday, April 30 at 9:25 a.m. ET
AstraZeneca agreed to help develop and manufacture an experimental recombinant adenovirus vaccine developed by Oxford University, joining a heated race to make an effective shot against the novel coronavirus. The company aims to build capacity to produce 100 million doses by the end of the year, CEO Pascal Soriot told The Financial Times. The company says the partners should have an idea of the vaccine's potential efficacy by July. Story
After assessing 19 existing drugs, an expert panel convened by the Indian government ranked Fujifilm's Avigan and Roche's Actemra as showing the most promise in terms of readiness and potential to fight the disease in the country, Times of India reported. The task force also said more clinical trial results are needed before these two drugs' potential can truly be determined.
Meanwhile, India's Glenmark Pharmaceuticals said it won regulatory clearance to run a local clinical trial of its generic version of Avigan, or favipiravir, on mild-to-moderate COVID-19 patients. The trial, the first for a novel coronavirus therapy in India, will enroll 150 patients.
Peter Marks, director of the FDA's Center for Biologics Evaluation and Research—which is responsible for reviewing vaccines—has emerged as the Trump Administration’s unofficial vaccine czar, according to Politico. He's reportedly been acting as the HHS' informal adviser in cross-agency collaborations with the NIH and the Biomedical Advanced Research and Development Authority.
At the same time, Senate Democrats are pressing HHS Secretay Alex Azar for explanations about former BARDA chief Rick Bright's recent reassignment. Bright has alleged that he was ousted after resisting pressure to funnel cash toward the old anti-malaria drug hydroxychloroquine, which President Trump had backed publicly as a COVID-19 "game changer."
Some parts of New Jersey are offering a saliva-based test developed by a Rutgers University lab. It avoids the discomfort associated with the use of a long swab in other tests and could be less risky for healthcare workers.
UPDATED: Wednesday, April 29 at 3:15 p.m. ET
After Gilead Sciences released word that new remdesivir trial data had turned up positive, the wait for details began. Further stoking enthusiasm, NIAID director Anthony Fauci at midday hailed the drug as real progress against the virus.
By midafternoon, the details had arrived. Remdesivir cut recovery time for hospitalized COVID-19 patients by four days, or 31%, in a National Institutes of Health-sponsored study pitting the drug against placebo in more than 1,000 patients. Story
In vaccine territory, the White House is said to be working on “Operation Warp Speed," a project that aims to deliver 100 million doses of a viable COVID-19 vaccine by the end of the year, according to Bloomberg. It would be a radical acceleration of the typical vaccine development timeline, typically described in years, not months. Story
Pfizer and BioNTech have taken another step forward with their potential COVID-19 vaccine. The biotech-pharma partners said they've finished dosing the first cohort in their phase 1/2 clinical trial. The first round, which took place in Germany, wrapped up just a week after the companies won the all-clear to run trials in the country. Story
Despite hiccups in clinical testing due to COVID-19, AstraZeneca thinks its late-stage pipeline will emerge from the pandemic largely unscathed. The company’s phase 3 pipeline currently features seven programs, most of which are testing cocktails involving anti-PD-L1 antibody Imfinzi and CTLA-4 prospect tremelimumab. Story
UPDATED: Wednesday, April 29 at 8:48 a.m. ET
Gilead's remdesivir met its primary endpoint in a study conducted by the National Institute of Allergy and Infectious Diseases, the drugmaker reports. NIAID plans to provide more details at an upcoming briefing. Analysts with Jefferies believe the drug will secure some type of FDA approval.
For his part, Former FDA commissioner Scott Gottlieb told Stat the drug could be "part of a toolbox" of drugs and tests to help with the COVID-19 response.
GlaxoSmithKline warned that despite its strong performance so far, the pandemic is a "very dynamic and uncertain situation" and risks remain throughout the year. Those risks include manufacturing and clinical trial disruptions, limits to patient access and more. Story
Japan's Shionogi is among the biopharma companies involved in COVID-19 R&D work, with programs in drugs and vaccines.
Alkermes withdrew its 2020 guidance due to the pandemic.
Authorities in France are cracking down on foreign investment in companies that might be vulnerable to takeovers due to the pandemic.
Australia is calling for an investigation into China's handling of the early stages of the COVID-19 outbreak.
UPDATED: Tuesday, April 28 at 3:03 p.m. ET
Pfizer CEO Albert Bourla told The Wall Street Journal the company's COVID-19 vaccine could be ready for emergency distribution by the fall. The company could further be ready for a broader rollout by the end of the year, he added.
Meanwhile, Pfizer is also bracing for a second-quarter sales hit as its reps are sidelined.
Merck is expecting a multibillion-dollar hit to 2020 sales from COVID-19 as the company has a heavy presence in physician-administered drugs—including its star cancer therapy Keytruda.
Researchers around the world are working to advance COVID-19 drug candidates, but a team at Oxford University's Jenner Institute got going with a head start and plans to kick off a 6,000-participant trial next month, The New York Times reports. The team is working with drug manufacturers in Europe and Asia to quickly produce up to 1 billion doses upon a potential approval.
Serum Institute of India is one drugmaker engaged in the project. The Indian vaccine giant is aiming to produce 40 million doses by September or October, Business Insider reports.
Novartis is planning to study canakinumab, which is approved as the rare-disease drug Ilaris, in patients with COVID-19. Investigators aim to study whether the drug can treat cytokine release syndrome, a severe immune overreaction.
Sen. Elizabeth Warren and Rep. Alexandria Ocasio-Cortez proposed a ban on large company mergers during the pandemic, NBC News reports.
After a lockdown to slow the spread of COVID-19, India's pharma production hub of Baddi is back online. Supply chain concerns still remain. Story
Novartis' new wet age-related macular degeneration drug Beovu has suffered from a safety alert and the COVID-19 pandemic, but execs still see blockbuster potential for the drug. Story
Even as manufacturing in China has resumed, the consumer economy hasn't yet recovered, the New York Times reports.
Amid the pandemic, the U.S. food supply chain has held up, but outbreaks at food processing plants have started to raise alarm.
UPDATED: Monday, April 27 at 11 a.m. ET
Sanofi and Regeneron will scale back a phase 3 study of IL-6 inhibitor Kevzara to treat COVID-19 after early results in a precursor study revealed disappointing results in severely ill patients. The drugmakers said the U.S. study will now include only critically ill patients treated with a 400-milligram higher dose of the drug. Story
Despite a lack of clinical proof of its efficacy in COVID-19, Gilead Sciences' highly touted investigational candidate remdesivir may score an early approval in Japan. Prime Minister Shinzo Abe reportedly said the drug could be fast-tracked for approval despite mixed early clinical data. Story
Speaking of remdesivir's mixed results, a new Chinese study has found the drug may be associated with lower sperm counts in test mice, Bloomberg reported.
Meanwhile, Roche's IL-6 inhibitor Actemra reportedly posted a win in an early French trial in treating cytokine storm in severe and critically ill COVID-19 patients with pneumonia.
Former FDA Commissioner Scott Gottlieb told CBS' Face the Nation on Sunday that doctors should not prescribe antimalarial hydroxychloroquine––a favorite of President Donald Trump––because clinical tests have shown little efficacy in COVID-19 and the drug carries possible safety hazards, too, particularly in combination with antibiotic azithromycin.
Gottlieb also blasted the Trump administration's decision to reassign former BARDA chief Rick Bright, saying the decision—possibly motivated by politics—would leave "uncertainty" about the federal government's leadership in finding a COVID-19 vaccine.
New York hospitals have reportedly begun testing antacid Pepcid as a possible treatment for COVID-19, the Daily Mail reported. The tentative testing follows positive anecdotal evidence out of China, and physicians are hoping to release results in a few weeks.
Merck & Co. and the Institute for Systems Biology announced a new collaboration to investigate and define the molecular mechanisms of the novel coronavirus and COVID-19, and identify targets for medicines and vaccines, the drugmaker said Monday.
As states begin to reopen businesses to restart their economies, Republican Ohio Gov. Mike DeWine has planned to drastically expand the state's coronavirus testing. DeWine said the state had reached a deal with ThermoFisher Scientific to boost access to testing reagents.
A House Democrat is pushing for a ban on corporate mergers until the end of the novel coronavirus pandemic, hoping to stanch a potential flood of big corporate buyouts of struggling businesses, Reuters reported. Rhode Island Rep. David Cicilline proposed banning transactions involving companies that weren't already in bankruptcy proceedings.
New York Sen. Chuck Schumer, a Democrat, is calling for an FDA crackdown on unregulated coronavirus testing kits after a swath of companies have begun marketing the untested kits to U.S. consumers.
Meanwhile, the FDA authorized three new coronavirus antibody testing kits, which are designed to determine whether individuals have already contracted the virus.
A pharma manufacturing hub in Baddi, India, has reportedly been reopened after the Indian government locked down the area as a "containment zone" earlier this month.
UPDATED: Friday, April 24 at 3:15 p.m. ET
Gilead Sciences is hoping a study of investigational candidate remdesivir, begun in February by the National Institute of Allergy and Infectious Diseases, will read out earlier than expected, Reuters reported. A recent trial in China showed no clinical benefit from the drug, though, as Gilead pointed out, the study ended early due to low enrollment.
World leaders––with the notable absence of the United States––pledged Friday to pool resources to help find a therapeutic or vaccine for COVID-19 in a World Health Organization joint effort.
UPDATED: Friday, April 24 at 9:00 a.m. ET
At Thursday's White House press briefing, President Donald Trump said researchers should look into whether ultraviolet light or disinfectant injections could kill COVID-19 in patients, prompting strong pushback. A spokesman for Lysol's parent company said that "under no circumstance should our disinfectant products be administered into the human body (through injection, ingestion or any other route)."
Appearing on CNN later, FDA commissioner Stephen Hahn said that disinfectant should not be injected into patients.
Sanofi CEO Paul Hudson said that the most complex component of a COVID-19 vaccine rollout will be delivering on manufacturing. The Sanofi/GlaxoSmithKline partnership is the primary group he sees as able to meet demand. Story
Meanwhile, Johnson & Johnson teamed with Emergent BioSolutions in the first of several expected deals to build capacity for its potential vaccine. J&J aims to supply more than 1 billion doses globally. Story
After the World Health Organization leaked a trial miss for Gilead's remdesivir in China on its website, a spokesperson for the drugmaker—plus analysts—said there was more to the story. Story
Chinese vaccine biotech Sinovac secured a loan and land as it works on a COVID-19 prospect. Story
After early hype from Trump and others for hydroxychloroquine, the FDA now says it's heard reports of dangerous side effects. The agency only recommends the drug be used in hospitalized patients. Story
Rep. David Cicilline called for a pause on mergers during the pandemic so large companies can't buy out struggling smaller competitors.
Market caps for 20 large biopharma companies fell by a combined $2.6 trillion during the first quarter, according to GlobalData. Story
UPDATED: Thursday, April 23 at 2:30 p.m. ET
Early data from a 237-patient randomized trial of Gilead Sciences' remdesivir in China––released by accident––reportedly showed no clinical benefit for patients with COVID-19, but the drugmaker has pushed back against that characterization and called the results "inconclusive."
Big Pharma's pursuit of therapeutics and vaccines for COVID-19 could give the industry a "once in a generation" opportunity rehab its tarnished public image, Eli Lilly CEO David Ricks told analysts in a first-quarter earnings call Thursday. Story
Pfizer and Teva have posted shortages of antibiotic azithromycin, which has been touted as a potential therapy for COVID-19 in combination with antimalarial hydroxychloroquine. Story
As hospitals redirect resources toward COVID-19 and patients put off less-urgent medical procedures and trips to the doctor, Medtronic has seen a serious impact on its bottom line—including a 60% drop in weekly revenue from the U.S., where the medtech giant does most of its business. Story
Icon is cutting costs drastically after 65% of its clinical trial sites have been affected by the novel coronavirus, the company said. Story
Researchers are beginning to take a hard look at using CAR-T therapy and engineered immune cells to combat the novel coronavirus. Based on previous research, Antonio Bertoletti from Duke-NUS Medical School's emerging infectious diseases research program suggests these immunotherapies might also be useful in treating SARS-CoV-2. Story
Researchers are turning their interest to blood pressure medicines after 72% of COVID-19-diagnosed patients age 65 and older presented hypertension, according to a Centers for Disease Control and Prevention report.
A screening of 3,000 New York people found 14% with novel coronavirus antibodies, indicating that up to 2.7 million of the state's residents may have already been infected with the virus, Reuters reported.
UPDATED: Thursday, April 23 at 8:38 a.m. ET
Rick Bright, a vaccine expert and BARDA director who was reassigned to NIH this week, issued a statement saying his transfer was due to his questioning of drugs and vaccines that "lack scientific merit." Science, not "politics or cronyism," has to lead the COVID-19 fight, he said, and pledged to call in the HHS inspector general to investigate. Story
Eli Lilly saw a $250 million benefit to first-quarter sales from increased medicine purchasing amid the pandemic.
Moderna vaccine phase 1 trial participants are set to receive another round of shots, indicating that the trial is on track so far, USA Today reports.
Valneva and Dynavax are teaming up to work on a COVID-19 vaccine prospect.
Research from Northeastern University says COVID-19 began spreading in U.S. cities much earlier than previously understood.
Judges are reporting a much lower level of court activity due to the pandemic, so the National Judicial College is starting a formal study on the topic, Law360 reports.
UPDATED: Wednesday, April 22 at 3:52 p.m. ET
Though Roche has appeared steady during the COVID-19 crisis, executives still warn of volatilities below the surface. Sales of Actemra jumped 30% in the first quarter, as interest grew in its use against the coronavirus’ immune complications. And while Ocrevus saw 38% growth, that’s down from last year’s 57%, due to multiple sclerosis patients delaying physician visits. Story
Meanwhile, Biogen—perhaps the most intimately affected drugmaker during this pandemic—has faced both unexpected demand and dosing delays for its top drugs. It pulled in about $100 million in sales as people rushed to secure treatment ahead of lockdowns, but it also expects to see future volatility, as some of its infusions still require a doctor present. Story
COVID-19 is also threatening to put the brakes on the fast-growing market for ATTR cardiomyopathy drugs—including Pfizer’s Vyndaqel, approved last year. While the halt may be temporary, investors say it’s enough to change near-term sales forecasts. Story
And to keep clinical trials going, PPD’s Accelerated Enrollment Solutions network set up a new program to transfer patients from study sites hit by the pandemic to other research facilities. Story
UPDATED: Wednesday, April 22 at 11:22 a.m. ET
Abbott Labs warned that its rapid COVID-19 testing device can produce false negatives if samples aren't handled properly. Healthcare providers shouldn't use "viral transport media" to transport or store them, the company said.
As Roche works to launch its own antibody test, CEO Severin Schwan called current antibody testing a "disaster." In a scathing assessment, Schwan said many of the tests are "not worth anything, or have very little use" and that he could make a better one "overnight in a garage." Story
Pfizer and its vaccine partner BioNTech scored approval from German authorities to start a phase 2 trial of their mRNA candidate. A U.S. trial is also expected to begin "shortly." Story
Dozens of manufacturing plants in a key drug-producing region in India have shut down, raising supply chain concerns. Story
Dr. Rick Bright, the leader of a federal agency in charge of working with biopharma companies to develop vaccines, drugs and diagnostics, is no longer with that agency. Story
The National Institutes of Health released COVID-19 treatment guidelines that outline how little progress has been made in drug research so far, NYT reports.
Officials in California released details of early COVID-19 deaths that preceded the United States' first confirmed death, the New York Times reports. The victims hadn't traveled, meaning the virus had been spreading in the U.S. earlier than thought.
And even as the U.S. deals with tens of thousands of COVID-19 deaths and more than 800,000 cases, CDC director Robert Redfield said a second wave next winter could be "even more difficult."
UPDATED: Tuesday, April 21 at 3:21 p.m. ET
A VA study of hydroxychloroquine, with or without azithromycin, “found no evidence” that the drug reduced the risk of mechanical ventilation in veterans hospitalized with COVID-19.
The FDA has approved an at-home testing kit from LabCorp. The kit requires people to send samples into labs for processing. Story
Pharma's reputation has soared amid the pandemic, with 40% of survey respondents reporting that their view of the industry has improved since the crisis began. Story
Many in the public have heard the vaccine development estimates of 12 to 18 months, but that’s unrealistic, an analyst says. Story
Big Pharma companies don’t want to go it alone in spending on COVID-19 R&D programs, several executives told the Financial Times. They’re looking for governments to spend billions to aid the programs. Story
UPDATED: Tuesday, April 21 at 9:40 a.m. ET
Pharma CEOs are asking that governments pour out billions of dollars in advance for the development and production of potential COVID-19 drugs. “If industry does not know if there will be a market in 18 months, [it] cannot carry all [the costs]. Industry alone can’t provide all the investment needed now for billions of doses,” David Loew, executive vice president of Sanofi Pasteur, told the Financial Times. “Society will have to finance this huge investment. My fear is the same as after the [2009 swine] flu pandemic, when everybody loses interest,” Takeda CEO Christophe Weber said. Story
A vaccine won't be available for general use for about three years, rather than the 18 months the National Institutes of Health has suggested, SVB Leerink analyst Geoffrey Porges says. "We view the current expectations for a vaccine in this timeframe as the equivalent of standing 24 feet (the usual distance is 8 feet) from a dartboard, with one dart in hand, and counting on a bullseye from one throw," Porges wrote in a Tuesday investor note.
Following other companies such as Pfizer and Novo Nordisk, Merck & Co. is now also expanding its patient assistance program, allowing eligible patients to get its medicines at no cost.
To ease shortages of drugs for COVID-19 patients who are on ventilators, the FDA is now allowing small compound pharmacies to temporarily fill the supply gap.
Japanese biotech Takara Bio's CEO Koichi Nakao told Nikkei his company plans to mass produce novel coronavirus vaccines as early as this year.
Cipla is committing INR 25 crore ($3.25 million) to support the Indian government's efforts to effectively combat the COVID-19 pandemic.
Meanwhile, the United Nations General Assembly passed a resolution Monday calling for an international collaboration to ensure rapid development, manufacturing and equitable access to medicine, vaccines and medical equipment.
About 4.1% of 863 adults tested positive for coronavirus antibodies in a study in Los Angeles, suggesting these people have been exposed to the pathogen even though some may not show symptoms, Reuters reported. This suggests the rate of infection may be 40 times higher than the number of confirmed cases.
President Donald Trump said he plans to sign an executive order temporarily suspending immigration into the U.S., saying he's trying to protect American jobs amid the economic blow caused by the pandemic. Administration officials said the order wouldn’t change the status quo, as the administration has already halted processing nearly every immigration form.