Top pharma executives from Sanofi, Takeda, 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.
The much-touted timeline of a vaccine within two years is too optimistic, an SVB Leerink analyst argues.
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As of Monday, the number of global confirmed cases is drawing near to 2.5 million, according to Johns Hopkins University's real-time dashboard, and more than 171,000 people had died.
Please read below for the latest updates. We'll be tracking the latest on this page. Also check out our updated-as-needed lists of drugs in testing, biopharma supply chain statements and travel and work-from-home policies.
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 NIH 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 on 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.
UPDATED: Monday, April 20 at 3:46 p.m. ET
Debate about whether the chloroquine family of antimalarial meds work in COVID-19 has dragged on since President Donald Trump publicly touted its use without definite proof. Now, to gather evidence, Novartis is launching a phase 3 clinical trial, planning to enroll about 440 hospitalized patients starting in the next few weeks.
That Novartis study will divide patients into three groups: hydroxychloroquine alone, hydroxychloroquine plus Trump-praised antibiotic azithromycin, and placebo. It follows several investigator-sponsored trials, which have turned up mixed results and are only fueling the debate rather than settling it. These include a recent study in China and one in France.
Researchers at the NIH and Gilead have published results from an animal trial of remdesivir, involving 12 rhesus macaques, showing that early antivrial treatment reduced COVID-19 symptoms and lung damage. Posted on the preprint site bioRxiv, the study replicated remdesivir dosing schedules being tested in an ongoing human trial. Story
Though the COVID-19 pandemic has upended the public markets—and thrown a wrench into what was expected to be a stellar IPO season—the biotech industry could be that particular cloud’s silver lining, as investors look toward additional windows and opportunities later this year. Story
Alexion is turning to its rare disease drug Ultomiris for COVID-19 after investigators expressed interest in exploring the potential of C5 inhibition. The company plans to start a global clinical trial in about 270 patients with severe respiratory syndromes, and enrollment is expected to begin in May. Story
A congressman is calling on the SEC to investigate last week’s leak of remdesivir data, along with its impact on the stock market and a 15% boost in Gilead’s share price. Though the antiviral is not supposed to be a moneymaker for the Big Pharma, news following its development has added billions to Gilead’s market cap. Story
An easier oral fluid test for COVID-19, which has been used by the City of Los Angeles to screen for cases, has received a nationwide emergency use authorization from the FDA. Story
UPDATED: Monday, April 20 at 9:12 a.m. ET
The FDA has granted emergency use authorizations to four antibody diagnostics—also known as serology tests—that promise to help identify individuals who have been exposed to the novel coronavirus. Now, the agency is working with the CDC and the NIH's National Cancer Institute and National Institute of Allergy and Infectious Diseases to make sure these blood tests work as they should. Story
The pan-European STOXX 600 index ended Friday with its biggest two-week percentage increase since 2015, helped by strong gains from the health sector, including Roche and Novartis, as both contribute their expertise in the pandemic.
Russia’s Health Ministry has been recommending AbbVie's HIV combo therapy Kaletra as a possible treatment for COVID-19 since reports of potential use emerged from China. Now, even before there's any concrete clinical evidence that the drug indeed works, a black market for the drug has developed in Russia, Reuters reported.
Even as the number of infections continues to climb in the U.S., the discussion has turned to reopening the economy. Protests demanding the rescission of lockdown policies have erupted in several states. Trump seemed to back the protests by tweeting “LIBERATE MICHIGAN,” “LIBERATE MINNESOTA,” and more on Friday. Story
Anixa Biosciences is working with Germany-based artificial intelligence life science company OntoChem to find new antiviral meds for COVID-19. Story
Lab operators and health officials still face supply shortages, test backlogs and unreliable results from coronavirus diagnosticsm, The Wall Street Journal reported. Adm. Brett Giroir, the administration’s testing coordinator, said the current testing capacity can only handle about half the demand through April.
Meanwhile, in the U.S., the FDA has stepped up seizures of prescription drugs being sent to American customers from Canada and other countries, where they are sold at cheaper prices, according to Kaiser Health News.
After President Trump again raised the theory that the novel coronavirus came from a bio lab in Wuhan, the lab struck back. "There is no way this virus came from us," Yuan Zhiming, vice director of the Wuhan Institute of Virology, told China's state-run CGTN.
UPDATED: Friday, April 17 at 2:50 p.m. ET
Global analytics firm Clarivate, in a sobering take on the hunt for a COVID-19 vaccine, said two vaccines from Moderna and Inovio will take at least five years to complete the development process through full regulatory approval. And neither company has a high probability of success, Clarivate said. Story
Sanofi has begun working with California startup Luminostics to build an at-home test for COVID-19 that would use a sample reader powered by a user’s personal smartphone. Using an adapter that clips over the phone’s camera and flashbulb, Luminostics’ low-cost, reusable device contains chemicals that faintly glow in the dark when certain targets are present. Story
The Biomedical Advanced Research and Development Authority (BARDA) is committing up to $483 million to bankroll late-stage clinical trials and scale up manufacturing for Moderna's COVID-19 vaccine candidate. Story
General Motors has shipped out its first batch of in-house developed ventilators to U.S. hospitals with severe COVID-19 patients, Reuters reported. GM said the Franciscan Health Olympia Fields hospital in Olympia Fields, Illinois, and Chicago’s Weiss Memorial Hospitals will receive shipments of 10 ventilators each Friday.
The World Health Organization (WHO) is casting doubt on whether recovered COVID-19 patients are developing antibodies to help build up so-called "herd immunity" to the novel coronavirus, according to a Friday briefing. A WHO expert said there was little evidence recovered patients had developed enough antibodies to help prevent reinfection.
UPDATED: Friday, April 17 at 9:25 a.m. ET
Biogen employees are among the first in the U.S. to have contracted the novel coronavirus after an ill-fated leadership meeting in Boston. Now, those who have recovered and their close contacts can volunteer blood samples and other medical data to a biobank the company is building with the Broad Institute of MIT and Harvard and Partners HealthCare to advance research into potential vaccines and treatments.
Roche has developed the Elecsys Anti-SARS-CoV-2 serology test to detect antibodies against SARS-CoV-2. It aims to have this test available by early May in countries accepting the CE mark and is working with the U.S. FDA for an emergency use authorization.
About 40 COVID-19-related clinical trials have been terminated in China, including two closely-watched studies of Gilead Sciences' antiviral drug remdesivir, after a slowdown of the outbreak made it hard to recruit patients.
Meanwhile, leaked early results from the University of Chicago Medical Center suggest remdesivir can swiftly control fever and respiratory symptoms. But as analysts were quick to note, the evidence is anecdotal, with the results coming from a non-controlled study at just one site. Story
Following the lead of AstraZeneca, which recently unveiled plans to test its blood cancer drug Calquence in COVID-19, rival BeiGene is also aiming to test its BTK inhibitor, Brukinsa, against the disease. The Chinese biotech has submitted a phase 2 trial design to the FDA and plans to enroll 42 U.S. patients, Forbes reported.
President Donald Trump recently touted anti-malaria drug chloroquine alongside antibiotic azithromycin as a regimen for COVID-19. As a result, nine drug manufacturers are reporting shortages of the antibiotic to the FDA.
In a statement on Thursday, FDA Commissioner Stephen Hahn cautioned that while the agency can now keep up with key drug review programs, "it is possible that we will not be able to sustain our current level of performance indefinitely," as many staffers have been allocated to work on COVID-19 activities.
AstraZeneca is donating three million surgical masks for U.S. healthcare workers combating COVID-19.
UPDATED: Thursday, April 16 at 3 p.m. ET
Millions of doses of hydroxychloroquine donated to the U.S. by Bayer have come under scrutiny after the quality of the drug's Indian and Pakistani active pharmaceutical ingredients and finished doses may have never passed FDA inspections, sources told Reuters. Bayer has donated 3 million tablets of the drug, called Resochin, to the U.S. national stockpile for treatment of COVID-19. Story
Dynavax and Sinovac are teaming up on a vaccine for COVID-19, combining the former’s vaccine adjuvant with the latter’s chemically inactivated coronavirus vaccine candidate. Story
Africa's confirmed cases of COVID-19 may shoot from the thousands up to around 10 million within the next three to six months, according to a regional WHO official. The projection was described as "tentative" and represented a worst-case scenario.
UPDATED: Thursday, April 16 at 8:56 a.m. ET
Baxter International is hiring 2,000 people to help the company handle higher global demand for medical devices. Of them, 800 are expected to be in the U.S. It's also increasing its air freight capacity to keep supplies of its equipment coming.
It's annual meeting season, and Gilead Sciences is the latest pharma company to transition to a virtual format.
Despite the fact that Fujifilm's Avigan hasn't been proven as an effective COVID-19 treatment, Japan and China are providing the drug to other countries, the Wall Street Journal reports, and politicians in each country are touting its use.
After a Rutgers saliva test won an FDA emergency use authorization, President Donald Trump touted it Wednesday.
If experts can't develop a vaccine in a timely fashion, the U.S. may have to do intermittent social distancing until 2022, Harvard researchers concluded.
The IHME model from the University of Washington has gained nationwide attention, including from the White House, but experts urged caution about relying too much on the model in the Annals of Internal Medicine. The model doesn't use "transmission dynamics," but instead is based on statistics with "no epidemiologic basis," they wrote.
Amid concerns the U.S. official death toll understates the actual number of fatalities, New York officials plan to contact nursing homes to identify victims who haven't been included in the state's tracking.
Inato has launched a platform to search for COVID-19 clinical trials.
UPDATED: Wednesday, April 15 at 3 p.m. ET
After the British drugmaker unveiled its COVID-19 vaccine tie-up with Sanofi, GlaxoSmithKline CEO Emma Walmsley said that multiple COVID-19 shots would likely cross the finish line. In all, there are 71 preclinical vaccine programs underway, while six projects have reached phase 1 and one is in phase 2, according to a tracker from the Vaccine Centre at the London School of Hygiene & Tropical Medicine. Story
The U.S. Department of Health and Human Services will ship out $1.4 billion to secure new ventilators from seven big medtechs. Five of the seven contracts—issued to Medtronic, GE Healthcare, Hill-Rom, ResMed and Vyaire Medical—were delivered under the Defense Production Act, which requires those devicemakers to prioritize the government’s requests before filling other orders. The other two were delivered to Zoll and Hamilton Medical. Story
India is hoping to rapidly expand its production of global active pharmaceutical ingredients to compete with China's dominance in the market amid COVID-19 lockdowns, Bloomberg reported. The country is one of the largest providers of generic drugs to the U.S. Story
In a commentary published recently in the journal Diabetes Research and Clinical Practice, a University of Miami researcher argued that DPP-4 enzyme-inhibiting diabetes meds could help fight COVID-19. Several DPP-4 inhibitors are already on the market, including Boehringer Ingelheim and Eli Lilly’s Tradjenta and Merck & Co.’s Januvia. Story
The World Health Organization has tasked ex-GlaxoSmithKline CEO Andrew Witty with helping accelerate development of a COVID-19 vaccine. Witty, currently the CEO of UnitedHealth Group's Optum unit, is taking a leave of absence from his job until around the end of the year to co-lead the WHO initiative. Story
UPDATED: Wednesday, April 15 at 8:47 a.m. ET
Gilead Sciences is among the companies with promising COVID-19 drugs and the company has now applied for a trademark for potential remdesivir packaging. But at press time, the company's shares were down on word that a second China trial had been stopped for lack of enrollment.
Helping bolster the nationwide testing push, Abbott has shipped more than 500,000 of its rapid COVID-19 tests throughout the U.S.
Amid the race for a COVID-19 vaccine, Pfizer's chief digital officer Lidia Fonseca told Fast Company that technology can help speed the process.
Eli Lilly and Bristol Myers Squibb have unveiled new patient access programs, and now Novo Nordisk has started a free 90-day insulin program for people who've lost insurance due to changes in job status. Story
After previously lowering antibody testing standards, the FDA has changed course and will now require data proving they work, CNN reports.
A new poll shows that almost half of voters favor using hydroxychloroquine to treat COVID-19 before U.S. researchers complete their study, but only 17% said they'd seek it out for themselves.
As the White House's Tuesday press briefing, President Donald Trump said the U.S. is halting funding to the World Health Organization. Bill Gates and others blasted the move.
Halting funding for the World Health Organization during a world health crisis is as dangerous as it sounds. Their work is slowing the spread of COVID-19 and if that work is stopped no other organization can replace them. The world needs @WHO now more than ever.— Bill Gates (@BillGates) April 15, 2020
While many look to next steps for various lockdowns, WHO's director-general Tedros Adhanom Ghebreyesus discussed recommended criteria for reopening.
As routine activity in much of the world is halted, millions of children could miss their measles vaccines.
Ivermectin, a topical head lice treatment, showed early promise in cell culture.
UPDATED: Tuesday, April 14 at 2:52 p.m. ET
Amid growing pressure to reopen the country, NIAID director Anthony Fauci told Associated Press that as it stands, a May 1 target is "a bit overly optimistic."
In a detailed discussion with Vox editor-at-large Ezra Klein, former FDA commissioner Scott Gottlieb outlined the process needed as he sees it for the U.S. economy to get going again.
Johnson & Johnson kicked off pharma's first-quarter earnings season on Tuesday, and execs offered a range of clues about how the pandemic is affecting its pharmaceuticals, consumer healthcare and medical devices businesses. Story
Aside from updating on how COVID-19 is affecting its business, J&J also launched a virtual series about its ongoing vaccine project. Story
Amid growing concerns about drug supply, Lupin Pharmaceuticals, Dr. Reddy's Laboratories and Biocon scored FDA endorsements for plants in India and Malaysia. Story
UPDATED: Tuesday, April 14 at 9:45 a.m. ET
China's health authorities have been recommending off-label use of drugs to tackle COVID-19. Now, the country's drug regulators have taken a step further by officially approving two herbal remedies for the disease.
Yiling Pharmaceutical's Lianhua Qingwen is now allowed to treat cough, fever and fatigue in mild-to-moderate patients, the company said in a disclosure (Chinese) to the Shenzhen Stock Exchange on Tuesday. Chase Sun's XueBiJing injection has added to its label an indication to treat inflammatory response and organ failure in severe patients, according to a company disclosure (Chinese).
Separately, China's National Medical Products Administration has greenlit two inactivated COVID-19 vaccines to start human testings. The two experimental shots are made by Sinovac and state-owned Sinopharm's Wuhan Institute of Biological Products.
AstraZeneca will start a global trial, dubbed Calavi, to examine whether its BTK inhibitor Calquence—already approved to treat certain blood cancers—can control potentially life-threatening cytokine storm in critically ill patients. Story
Sanofi and GSK, two of the world’s biggest vaccine makers, are joining forces to develop a recombinant DNA vaccine, aiming to enter clinical testing in the second half of 2020. Story
The pandemic pushed up sales of Johnson & Johnson's over-the-counter pain reliever and fever reducer Tylenol in the first quarter. But the company is dialing down its full-year sales and earnings forecasts due to the global crisis. Story
Meanwhile, Swedish rare disease specialist Sobi also reported better-than-expected first-quarter numbers. The company cited strong growth for hemophilia products partly due to "advance purchases to secure access to treatment for a longer period than normal" amid the pandemic.
A phase 2b trial in Brazil suggests that high, 600 mg-twice-daily dose of chloroquine might cause serious heart problems. The investigators halted patient recruitment to that arm after observing an abnormally high rate of heart arrhythmias and suggested that particular dosing strength "should not be recommended for COVID-19 treatment because of its potential safety hazards," according to results published in the preprint site medRxiv.
At the same time, some lawmakers in Brazil has introduced a bill that would allow the government to temporarily suspend patents for medical products that could be used to fight COVID-19 or any future public health emergency, Stat reported.
CDC Director Robert Redfield told NBC News that antibody tests should be in place before the coronavirus hits again. "It may help hospitals, if they look at the next wave, which I believe we will have in late fall or winter, they may be able to identify a group of health care professionals that are no longer likely to be susceptible," he said. And former FDA commissioner Scott Gottlieb also warned of possible return of the virus.
South Dakota launched a clinical trial to test hydroxychloroquine in treating and potentially preventing COVID-19. The study plans to include 2,000 individuals exposed to COVID-19, including front-line healthcare workers and other high-risk patients, The Hill reported.
UPDATED: Monday, April 13 at 3:57 p.m. ET
Rutgers University has received the FDA’s first emergency authorization for a COVID-19 diagnostic that uses easy-to-collect saliva samples instead of the more difficult deep nose swabs. This testing method could allow broader population screening; however, the agency’s green light only covers its use at the university’s New Jersey lab, for the time being. Story
Eli Lilly is enlisting its JAK inhibitor Olumiant in an adaptive, master trial run by the NIH's National Institute of Allergy and Infectious Diseases. The Olumiant arm will start this month in the U.S. and will potentially expand to include Europe and Asia, with data expected in two months. Story
The South Korean drug developer Celltrion aims to begin human testing of its antibody treatment for COVID-19 in July. The company is also advancing a ‘super antibody’ candidate designed to eliminate all related coronavirus strains. Story
As patients refrain from visiting physicians, retail prescriptions of certain drugs are suffering, while others appear to be holding steady, according to analysts. Overall, prescriptions of drugs for acute conditions have dropped 28% since February. Story
As the U.K. teeters toward Europe’s worst COVID-19 death toll—it hit more than 10,000 deaths over the weekend—researchers are decrying the country’s delay in getting plasma therapy into trials to help patients with COVID-19. Story
The FDA authorized CytoSorbents’ “plug and play” blood filtering device to help ICUs strip out the dangerous immune proteins behind cytokine storms. The cartridges are designed to work with various dialysis and ECMO machines. Story
UPDATED: Monday, April 13 at 9:18 a.m. ET
Gilead provided results from 53 severe COVID-19 patients treated with remdesivir on a compassionate use basis in a paper published in The New England Journal of Medicine. During a median follow-up of 18 days, 36 patients (68%) had a clinical improvement, and the mortality rate was 18% among patients receiving invasive ventilation. Jefferies analysts argue the data "suggest remdesivir may work and is generally safe." Story
In hindsight, many people have criticized Biogen’s decision to continue with an exec meeting in Boston in late February. The event is an example of what epidemiologists call “superspreading events” of COVID-19. Besides the 99 cases in Massachusetts, some of the earliest cases in Indiana, Tennessee and North Carolina were also linked to the conference.
Bausch Health has started a clinical trial in Canada evaluating the use of RSV drug Virazole to treat hospitalized patients with respiratory distress due to COVID-19.
Generic giant Amneal Pharmaceuticals has committed to producing about 20 million hydroxychloroquine tablets by mid-April, but it will be difficult to make more after that as the company faces API supply constraints, co-CEOs Chirag and Chintu Patel told Reuters.
As hospitals experience a surge of coronavirus patients, supplies of some antibiotics, antivirals and sedatives required for patients on ventilators have also been exhausted, according to the Washington Post.
"I think going forward, the WHO needs to commit to an after-action report that specifically examines what China did or didn't tell the world, and how that stymied the global response to this," former FDA commissioner Scott Gottlieb said on CBS News' "Face the Nation."
The U.S. still needs to "further ramp up testing, both diagnostic as well as the antibody tests," FDA Commissioner Stephen Hahn said on ABC. While increasing testing capabilities is urgent, "these tests have to be valid and accurate and reliable," he said on NBC.
Singapore's ASLAN Pharmaceuticals paused enrollment of a clinical trial testing its anti-IL-13Rα1 antibody, ASLAN004, a potential challenger to Regeneron and Sanofi’s blockbuster Dupixent, in severe atopic dermatitis. Story
The FDA allowed emergency use of Steris' V-PRO systems for decontaminating N95 masks. The agency estimates the tech will allow 750,000 masks to be processed and reused per day nationwide. Story
U.K. Prime Minister Boris Johnson has been discharged from the hospital. He thanked healthcare workers for saving his life, acknowledging that his situation "could have gone either way."
UPDATED: Friday, April 10 at 2:20 p.m. ET
Amneal Pharmaceuticals could soon run out of the raw ingredients to supply generic hydroxychloroquine after its Finnish supplier was forced to turn over product to the Finnish government, Reuters reported. Amneal was due to produce 20 million doses of the antimalarial in April but may now to have delay those plans, the company's co-CEOs said.
The World Health Organization (WHO) is warning against lifting coronavirus restrictions, arguing the moves could lead to a "deadly resurgence" of COVID-19 in countries where infection rates have flattened. The WHO has also warned that infection rates in Africa have taken off precipitously, Reuters reported.
Amazon has begun outfitting an in-house COVID-19 testing lab for front-line warehouse and delivery workers. According to the Financial Times, more than 50 Amazon-owned facilities have seen confirmed cases of the novel coronavirus. The retailing giant has already instituted daily temperature checks as more than 100,000 people arrive for work each day, while also distributing masks to its shipping sites and its Whole Foods grocery stores. Story
The FDA has granted an emergency authorization to a COVID-19-fighting blood purification system to treat patients with cytokine storms, the harmful, cascading activation and release of white blood cells as the body overreacts to the infection. Story
UPDATED: Friday, April 10 at 10:09 a.m. ET
Following similar moves by Bayer, Novartis and Mylan, Sanofi is donating 100 million doses of Plaquenil, an off-patent branded version of hydroxychloroquine, to 50 countries around the world. The company said it had already increased its production capacity by 50% and could further increase production over the coming month.
Gilead's promising COVID-19 drug candidate remdesivir could be made at $9 per treatment, while the estimated manufacturing cost for generic hydroxychloroquine stands as little as $1 per course, a study published in the Journal of Virus Eradication found.
Twin brothers Thomas and Andreas Struengmann own nearly half of German biotech BioNTech. Now, thanks to the firm's COVID-19 vaccine agreements with Pfizer and Fosun Pharma, the two are worth $9.7 billion each, versus $4.4 billion last year. They are now among the richest in the healthcare industry, according to Forbes.
China's CanSino Bio has become the first in the world to advance a COVID-19 vaccine into phase 2 testing. The company decided its recombinant COVID-19 vaccine, Ad5-nCoV, could move forward based on "the preliminary safety data of the phase 1 clinical trial," it said. Story
Vir Biotechnology has picked South Korean CDMO Samsung Biologics as its third partner in the manufacturing of its antibody as a potential COVID-19 treatment. The $362 million deal follows Vir's agreements with WuXi Biologics and Biogen. Story
BioCryst Pharmaceuticals has started enrolling COVID-19 patients in a clinical trial of its antiviral drug galidesivir. The company received government funding to test the drug for yellow fever, but it's now shifting the focus to SARS-CoV-2. Story
Some doctors are trying to reduce their reliance on ventilators for COVID-19 patients when they can due to reports of abnormally high death rates for patients using the breathing machines, the Associated Press reported.
UPDATED: Thursday, April 9 at 2:50 p.m. ET
Pfizer and BioNTech are planning to ramp production of a potential COVID-19 vaccine to put millions of doses on the market by year's end, assuming a candidate goes to human trials by April. The partners reached a deal in March to develop and co-market a possible vaccine. Story
Gilead Sciences has made major changes to multiple trials of investigational COVID-19 candidate remdesivir, quadrupling the enrollment target and switching the primary endpoint. The trial of patients with severe COVID-19 has swelled in size from 400 subjects to 2,400 participants, and Gilead has changed the primary endpoint to focus on the odds of improvement on a seven-point scale that runs from death to not hospitalized. Story
Initial data from COVID-19 clinical trials of Sanofi and Regeneron's IL-6 inhibitor Kevzara could be released as early as next week, Regeneron CSO George Yancopoulos told Reuters. The drug is one of a group of IL-6 inhibitors being evaluated to treat the disease.
Takeda and CSL Behring have signed a deal to co-develop a plasma-based therapy for COVID-19. Takeda had been working on TAK-888, a polyclonal hyperimmune globulin against SARS-CoV-2, the virus that causes COVID-19, but the partners will now focus their efforts on a single, unbranded medicine. Story
The U.S. federal government has tapped Philips to manufacture hospital ventilators for critical COVID-19 care, with the company planning to double its production by May—while the automaker General Motors has been contracted to deliver 30,000 by the end of August. Story
Pfizer is planning to launch a trial in early summer for a newly discovered candidate to treat severe COVID-19, the drugmaker said. Pfizer said the candidate blocks the new virus, which causes COVID-19, from replicating, with hopes it could slow or stop the spread of the virus in patients with mild to moderate symptoms. Story
Xerox is partnering with the ventilator manufacturer Vortran to help mass produce its portable, disposable hardware for COVID-19. Vortran’s FDA-approved GO2Vent and its monitoring devices are not designed as full replacements for the heavy, durable ventilators found in intensive care units—instead, they are used in emergency situations and ambulances, or while transporting patients through the hospital and during procedures such as an MRI. Story
President Donald J. Trump has denied having any financial interest in antimalarial COVID-19 hopeful hydroxychloroquine after his administration has touted the drug's chances as a therapeutic, The Independent reports.
Chinese doctors at the front line of the novel coronavirus pandemic are casting doubt on hydroxychloroquine's efficacy to treat COVID-19, citing a lack of clear evidence. One doctor, The Wall Street Journal reported, has touted AbbVie's HIV drug Kaletra as a possible option.
UPDATED: Thursday, April 9 at 8:15 a.m. ET
Pfizer is exploring whether rheumatoid arthritis drug Xeljanz might be able to help COVID-19 patients, along with a host of other research programs.
Fujifim is starting a phase 2 test of its flu drug Avigan in the U.S. The drug isn't approved in the U.S. and is undergoing phase 3 testing in Japan in COVID-19.
Former FDA commissioner Scott Gottlieb told Time he regrets leaving the FDA last year, and that it pains him to not be part of the government's response. Still, Gottlieb has been a vocal expert discussing the pandemic on news shows and on Twitter, and he was involved in publishing a roadmap for reopening the U.S.
While some may be hoping warmer weather slows the pandemic, the virus is unlikely to be seasonal, researchers wrote in a paper published by National Academy of Sciences, Engineering, and Medicine.
Inovio is pushing its novel coronavirus vaccine candidate into human testing on the heels of similar study starts by Moderna and China's CanSino Bio. Story
Some experts are calling on President Donald Trump to restrict patents for COVID-19 drugs or diagnostics, Bloomberg reports. Germany and Israel have already decided to do so.
The CDC has backed away from language endorsing the use of hydroxychloroquine in patients with COVID-19, USA Today reports.
Aside from its move to boost patient access amid the pandemic, Bristol Myers Squibb is also donating $345,000 of personal protective equipment, NJ.com reports.
The pandemic is hitting some industries harder than others, and analysts with Morningstar wrote that the pharmaceutical and biotech industries seem well positioned despite challenges.
Bayer is making face shields in St. Louis as part of its COVID-19 response, Fox 2 reports.
While some may be clamoring for easing of lockdowns, some ongoing social distancing measures will be needed until there's an available vaccine, a study says.
Fake drugs have been reported in Africa as counterfeiters aim to take advantage of supply chain disruptions, BBC reports.
UPDATED: Wednesday, April 8 at 3:30 p.m. ET
With Sanofi and Regeneron's IL-6 inhibitor Kevzara running through clinical trials to treat COVID-19, the partners have agreed to pump the brakes on reworking their partnership on the drug as originally intended. Both drugmakers announced in June they would restructure their deal for Kevzara and sales laggard PCSK9 med Praluent. Story
U.S. Customs and Border Enforcement will seize exports of respiratory, surgical masks and surgical gloves to determine whether some of that equipment should be kept stateside to combat the novel coronavirus, Reuters reported. The ban follows an order from President Donald J. Trump on Friday to halt export of key medical supplies. Story
Gilead Sciences has launched a $20 million fund to support relief organizations including $1 million each to nearby Gilead and Kite headquarter communities in San Mateo and Los Angeles counties affected by the novel coronavirus pandemic. A Gilead spokesperson said the funding will go to organizations it has existing donor relationships with including cancer groups and HIV-community groups. Gilead also started a campaign to match employee donations to three global relief organizations. Story
GlaxoSmithKline and AstraZeneca are launching a joint COVID-19 testing lab at the University of Cambridge that will process 30,000 tests per day, the drugmaker said. It will also explore the use of alternative chemical reagents for high-throughput testing to stretch the U.K.’s overall diagnostic supply, as previously reported by Bloomberg. Story
An antimalarial compound developed at St. Jude's Children's Research Hospital, SJ733, has shown some promise in early study findings. Story
As well as evaluating antibodies from COVID-19 patients, as is happening in AbCellera’s partnership with Eli Lilly, AstraZeneca is working with prospects from humanized mice and laboratory approaches such as phage display to develop a therapy for the disease. The timeline suggests AstraZeneca is trailing the front-runners—Regeneron is targeting an “early summer” study start—but is still advanced enough to come to market before the pandemic is resolved. Story
A new breakdown from Medidata (PDF) is showing a major hit on global clinical trials due to the novel coronavirus pandemic, particularly for endocrine and cardiovascular studies. The firm’s analysis showed trial enrollment was down around 65% in March compared with the year before. The U.K. was the hardest hit, with trial enrollment down 80.1% year over year. Story
COVID-19 conversations around disease states have increased 1,000% among healthcare professionals and 2,500% among consumers, with both sharing the same types of content, according to a social listening study that ran from Jan. 1 through March 19. Story
In a new study, researchers showed that a vaccine based on the parainfluenza virus 5 that’s believed to cause the canine respiratory disease could also be employed for COVID-19 after the drug protected all trial mice from the lethal Middle East respiratory syndrome (MERS) virus. Story
PPD’s site solution unit Accelerated Enrollment Solutions has penned a pact with California-based virtual trial specialist Science 37 to help it run trials remotely. The pact allows patients using AES to go through Science 37’s Metasite, a hybrid clinical trial platform that combines traditional site visits with remote trial capabilities, “allowing patients located virtually anywhere to participate in a clinical trial." Story
UPDATED: Wednesday, April 8 at 8:45 a.m. ET
In an interview with CBS, Regeneron Chief Scientific Officer George Yancopoulos described some of the company's COVID-19 drug programs in the works and said that within a month or two, scientists will know which drugs are "really working in a controlled fashion."
Boehringer Ingelheim is offering employees paid leave to volunteer, plus donating millions of euros to local response and committing thousands of lab hours for COVID-19 research.
Former biotech executive Martin Shkreli says he wants to be freed from prison so he can help find treatments for COVID-19, The Associated Press reports, citing his attorney.
Officials in the U.S. and elsewhere are working on serology testing to learn how many people who've had infections and might be immune going forward, former FDA Commissioner Scott Gottlieb tweeted.
In U.S., experts suggest to me rate is lower. My informal survey of thought leaders in this area puts estimate anywhere from 1-5%. Ultimately we must confirm this with serology studies (which are underway). But it falls short of the 50-70% needed to achieve “herd” immunity 8/n— Scott Gottlieb, MD (@ScottGottliebMD) April 8, 2020
Former FDA commissioners say the agency's recent Emergency Use Authorization for malaria drugs to treat COVID-19 threatens further research on the meds and undermines the agency's authority, Science reports.
While the pandemic has hit many industries hard, The Associated Press reports Washington, D.C., lobbying is up significantly in recent months.
In Foreign Policy, 12 experts laid out predictions for how the pandemic will change the world.
UPDATED: Tuesday, April 7 2:29 p.m. ET
A 199-patient trial of AbbVie's HIV drug Kaletra showed preliminary positive results in COVID-19, Lancaster University reports. The team studied the drug in early stages of the pandemic and found that patients who were given Kaletra plus standard of care seemed to improve faster than those who received only standard of care.
Like several other drugmakers, Eli Lilly is moving to a virtual annual shareholder meeting. The meeting is set for May 4.
As the U.S. works to move past the pandemic, the country will have to hire thousands of public health workers and implement a vast surveillance system, former FDA Commissioner Scott Gottlieb predicts.
The Interfaith Center on Corporate Responsibility wrote to 14 drugmakers urging a collaborative approach to developing drugs, vaccines and diagnostics.
Boehringer Ingelheim has made a $500,000 contribution to the American Thoracic Society's COVID-19 Crisis Fund.
UPDATED: Tuesday, April 7 9:16 a.m. ET
President Donald Trump said he asked U.S. pharmas to offer their experimental COVID-19 drugs to help U.K. Prime Minister Boris Johnson, who's in the ICU because of the disease. He didn't name the companies or the drugs, but he just held a meeting with CEOs of Amgen, Roche's Genentech, Gilead Sciences and Regeneron.
In response to the pandemic, Eli Lilly is introducing the Lilly Insulin Value Program, which allows patients to fill their prescription of Lilly insulin for $35.
Meanwhile, Bristol Myers Squibb is expanding its existing patient support programs, offering access to any of its branded drugs for free to eligible unemployed patients in the U.S. who have lost their health insurance due to the COVID-19 pandemic.
Alexion Pharmaceuticals, the rare disease drugmaker, is planning to test its pricey Soliris drug in COVID-19 patients. The phase 2 trial is launching shortly, GlobalData says. Soliris is approved to treat several rare diseases, including paroxysmal nocturnal hemoglobinuria.
Karyopharm is rolling its own product into a coronavirus test—and this time, it's a cancer drug. Xpovio, a XPO1 inhibitor approved to treat multiple myeloma, has shown preclinical activity against coronaviruses, the company said.
Trump has a small personal financial interest in Sanofi, which makes Plaquenil, an off-patent branded version the malaria drug he's touting as a COVID-19 treatment, The New York Times reported.
Critics also pointed out Novartis, which manufactures a generic version of the drug, previously paid Trump's then-personal lawyer Michael Cohen $1.2 million for consulting on healthcare policy. Multiple generics makers turn out their own versions of hydroxychloroquine and a related drug, chloroquine, and Novartis' Sandoz unit has pledged to donate 130 million doses.
India has lifted the export bans of 13 APIs and finished drugs, Business Standard reported. These include vitamins, antivirals and some common antibiotics; curbs on hydroxychloroquine are also said to be removed.
Karyopharm said it plans to test its multiple myeloma drug Xpovio in hospitalized patients with severe COVID-19. The company argues the drug's target, XPO1, also facilitates the transport of several viral proteins from the nucleus of the host cell to the cytoplasm, and that it boosts pro-inflammatory transcription factors.
Cancer Research UK said it has been forced by the COVID-19 crisis to make funding cuts to its “existing grants and institutes by up to 10% and its national network of Centers by around 20%.” Story
Following its donation of 500,000 face masks to the New York City, Merck & Co. is donating 300,000 masks to its home state New Jersey in response to requests for protective gear for frontline workers.
A survey by Medisafe showed 56% of patients and caregivers are concerned that the pandemic will disrupt their access to medication.
IQVIA has launched the COVID-19 Trial Matching Tool at c19trials.com, an online platform that matches individuals with specific COVID-19 studies. Story
Peter Navarro, President Trump’s trade adviser, warned the administration in late January that the coronavirus crisis could cost the U.S. trillions of dollars and put millions at risk of illness or death, according to The New York Times. At that time, the President was playing down the risks of the virus.
After rolling out a road map to navigating through the pandemic to reopening businesses, former FDA commissioners Mark McClellan and Scott Gottlieb are now working with lawmakers on a framework. In a report obtained by Politico, the two caution that antibody testing may not be enough to determine if individuals are immune and can therefore return to the workplace.
UPDATED: Monday, April 6 at 3:25 p.m. ET
The FDA hasn't yet seen a broad lack of active pharmaceutical ingredients shipped from China due to the outbreak, Commissioner Stephen Hahn said this weekend, but the agency is closely monitoring the situation and has seen spot shortages of certain drugs due to increased demand—including the malaria drugs chloroquine and hydroxychloroquine. Story
GlaxoSmithKline and AstraZeneca are considering forming a joint lab in the U.K. to test different reagents and chemical mixtures to expand the country’s supply of COVID-19 diagnostic tests, according to a report from Bloomberg. Story
Meanwhile, GSK partnered up with Vir Biotechnology to develop vaccines and treatments for the novel coronavirus and snagged a $250 million investment. Story
Developing and producing vaccines can be expensive, but Bill Gates said he has the cash to spare—even if some don’t work out. The billionaire told Trevor Noah on The Daily Show that he plans to bankroll factories for seven promising vaccines, even though he only expects two to succeed, at the most. Story
Gilead is also ramping up its manufacturing capabilities to increase access to its candidate remdesivir. The Big Biotech said process improvements have cut the antiviral’s production timeline from one year to six months. Story
Still, treatments need to get to market quicker, according to former FDA Commissioner Scott Gottlieb, who says the country needs a fast-tracked therapy available by the end of the summer. Story
In the meantime, biotech researchers are forming partnerships around everything from cloud computing to high-throughput screening in an effort to speed COVID-19 vaccines to market. Story
And in testing, Ortho Clinical Diagnostics and Eurofins—with its Viracor and Boston Heart Diagnostics subsidiaries—outlined their plans to provide high-throughput COVID-19 antibody screening to gauge whether a person had a previous infection. Story
UPDATED: Monday, April 6 at 9:05 a.m. ET
Pfizer is committing $40 million to support global anti-COVID-19 efforts. The New York pharma has also adapted its U.S. patient assistance program to ensure supply, and it's accepting telehealth prescriptions where possible.
Tesla has built a prototype ventilator with in-house automotive parts, rather than with traditional components desperately needed by medical device makers to ramp up ventilator production, according to Forbes. It's not clear when the automaker will be able to produce the devices in high volume.
During a press briefing on Sunday, President Donald Trump again backed hydroxychloroquine to treat COVID-19 patients. “We don’t have time to say, ‘Gee, let’s take a couple of years and test it out, and let’s go and test with the test tubes and the laboratories,’” he said. Meanwhile, Trump called India Prime Minister Narendra Modi on Saturday to request the country release the anti-malaria drug, which has been banned from export by New Delhi.
Former FDA commissioner Scott Gottlieb said, "There's no room for sluggish political leadership" when it comes to the urgent need of developing an effective treatment.
We should put everything we have into developing an effective medicine. It should be a coordinated, deliberate, urgent industrial policy. There's no room for sluggish political leadership when it comes to this urgent priority. Everything depends on our rapid success.— Scott Gottlieb, MD (@ScottGottliebMD) April 5, 2020
Patients are rushing to join clinical trials to get Gilead Sciences' experimental remdesivir. The torrent of interest has prompted the NIH to expand a study, the Associated Press reported.
The FDA is facilitating development and access to convalescent plasma and hyperimmune globulin for COVID-19. These products are made from blood donated by people who have recovered from the disease.
Facing a slowdown from the pandemic, Bayer has exercised a right to terminate a draft Roundup settlement agreement it had reached with a group of firms and extended the negotiations through April, according to The Wall Street Journal.
3M came out Sunday with a statement refuting media reports that a shipment of 3M personal protective equipment (PPE) bound for Germany was allegedly seized and diverted by U.S. authorities.
U.K. Prime Minister Boris Johnson has been hospitalized after showing "persistent symptoms" of COVID-19.
SGS Digicomply has launched COVID-19 INTEL, which uses AI to help scientists keep up with the large and growing volume of research related to the novel coronavirus.
UPDATED: Friday, April 3 at 3 p.m. ET
The U.K. government is planning to launch the world's largest clinical trial to treat COVID-19, repurposing drugs approved to treat malaria and HIV. The problem is, it might take a while. Almost 1,000 patients from 132 hospitals have already been recruited in 15 days and thousands more are expected to join in the coming weeks, the U.K. health department said. Story
Health care workers on the front line of COVID-19 fight will be the first to receive Johnson & Johnson's investigational vaccine, CSO Paul Stoffels told Nikkei. The drugmaker will work with all governments around the globe to offer access to the vaccine once it's ready for dosing, Stoffels said. Story
The University of Pennsylvania is launching a clinical trial for the much-hyped malaria med hydroxychloroquine to evaluate its effect on COVID-19. The trial is set to start next week and will study 400 people in three different substudies. Story
UPDATED: Friday, April 3 at 8:42 a.m. ET
Under normal circumstances, a vaccine wouldn't reach the market until years of tests proved its safety and efficacy. But Germany's CureVac and BioNTech, which are set to start testing their mRNA shots on humans within the coming weeks, are calling for global drug regulators to "abbreviate" the regulatory path amid the pandemic. Story
The FDA's rushing to allow emergency use of chloroquine for COVID-19 despite solid efficacy evidence may have a side effect: Other therapies in clinical testing with potential for the disease may find it hard to recruit patients, Politico reported.
GlaxoSmithKline is offering its vaccine adjuvant to Innovax Biotech in China to develop a recombinant protein-based vaccine. The two companies have an ongoing partnership to design a new HPV vaccine. Story
FluGen, Bharat Biotech and the University of Wisconsin-Madison have teamed up for the latest vaccine collaboration between industry and academia.
The U.S. CDC is set to reverse its previous guidelines and start recommending face masks for all people in public, even if they show no symptoms, Stat reported. The World Health Organization, which has been opposing the idea of face masks for the general public, is also assessing whether it should change its advice, according to the BBC.
Meanwhile, the FDA will no longer block the import of KN95 masks from China amid a shortage. KN95 is considered the Chinese equivalent to the U.S. N95 standard, which is used in products for healthcare workers to protect against airborne pathogens.
Google is using the location data it collects from smartphones to show whether people are following lockdown advice. "We have heard from public health officials that this same type of aggregated, anonymized data could be helpful as they make critical decisions to combat COVID-19," two Google executives wrote in a blog post Friday.
Although Houston has not reported a huge increase of confirmed coronavirus cases, a jump in hospital admissions suggests many coronavirus cases may still remain undetected as testing lags, NBC News said.
And the U.K. government plans to issue an “immunity passport” for people with antibodies—and presumably, immunity—against the novel coronavirus so that they can return to work. But the initiative is dependent on rolling out an efficient antibody test.
UPDATED: Thursday, April 2 at 2:29 p.m. ET
Novo Nordisk says it'll have enough medicine to supply during the pandemic, but demand spikes could cause pharmacies to run out intermittently. The company also has resources to help patients afford their needed drugs.
With COVID-19 testing still spotty around the country, BD will begin offering a point-of-care antibody assay, which operates like a combination of a blood glucose test and a home pregnancy test. Using just a fingerstick of blood, the small test strip provides results within 15 minutes. Story
A new and unproved COVID-19 cell therapy from New Jersey biotech Celularity has been given a quick trial approval by the FDA, just days after President Donald Trump’s personal attorney and former New York City Mayor Rudy Giuliani pushed for the med to be tested ASAP. Story
A public health expert told SVB Leerink analyst Geoffrey Porges he believes the New York City outbreak will peak in early May and that social distancing will be required in the U.S. for longer. The expert said the U.S. "missed the window for early prevention" and estimated the actual number of U.S. cases is five to 10 times higher than the confirmed count, Porges wrote.
After being asked numerous times about COVID-19 herd immunity, Evercore ISI analyst Josh Schimmer concluded it'd take about 90% of the population to achieve such a level of protection. That'd only be achievable through a vaccine, he wrote in a note to clients.
On that front, a team of University of Pittsburgh School of Medicine researchers developed a vaccine that can be delivered into the skin with a Band-Aid-like patch made of 400 tiny needles. When they tested it in mice, the vaccine produced antibodies to fend off the virus within two weeks. Story
With Thursday's update from the Labor Department, at least 10 million Americans have been put out of work so far due to the pandemic.
UPDATED: Thursday, April 2 at 8:59 a.m. ET
NIAID Director Anthony Fauci has taken a central role in the U.S. amid the pandemic, and, in a highly polarized country, his efforts to shine truth on the situation have brought the need for a security detail, The Wall Street Journal reports.
Amgen is joining the race for a COVID-19 drug through a partnership with Adaptive Biotechnologies. Story
Regeneron employees have been working long hours to make viral transport media, a key component of COVID-19 tests. The drugmaker plans to supply 500,000 units.
Medical professionals at Eli Lilly, Pfizer and Merck may leave their current posts to go help patients and others amid the COVID-19 fight while continuing to receive their salary. The companies employ thousands of doctors, nurses, pharmacists, medical laboratory technicians and more. Story
The European Medicines Agency limited use of chloroquine and hydroxychloroquine to clinical trials and emergency use programs for patients with COVID-19. The drugs have garnered a lot of attention and, on Wednesday, The New York Times reported a small study in China had generated a positive result. Story
The pandemic shows why pharma should move in a "more sustainable direction," Daiichi Sankyo U.K. manager Manuel Reiberg said at a digital conference.
Roche Diagnostics issued an apology (Chinese) in China on Wednesday for labeling the novel coronavirus as "Wuhan coronavirus" in three products on the unit's Argentina website. The company said it presented the names in January—before the official tags SARS-CoV-2 and COVID-19 came along—and forgot to update the website.
President Donald Trump is weighing grounding domestic flights from COVID-19 hot spots, The Wall Street Journal reports.
EUSA Pharma reported positive preliminary findings of its Sylvant, or siltuximab, in COVID-19 patients from a study at a hospital in Italy.
A consensus is taking shape around America that April and May will be tough months amid the COVID-19 fight, Axios reports. Life might return to normal slowly or geographically afterward.
AbbVie is donating $35 million to boost hospital capacity and help with food and essential supplies for vulnerable populations.
The mayor of Los Angeles, Eric Garcetti, encouraged the city's 4 million residents to wear masks or makeshift cloth to cover their faces when they leave home, The Associated Press reports.
UPDATED: Wednesday, April 1 at 3:16 p.m. ET
Smith+Nephew is preparing to mass produce a ventilator designed by University of Oxford and King’s College London. U.K. regulators are reviewing the design, and the company plans to start manufacturing upon approval. Story
Microsoft and NantWorks’ ImmunityBio are working together to map out the spike protein of the novel coronavirus to learn more about how the virus infects human cells. Story
Brii Biosciences is working with a Chinese hospital and university on COVID-19 antibodies, and the team plans to start human testing in the third quarter. Story
As COVID-19 patients recover, many are donating blood plasma to help newly sick patients fight the infection, The Wall Street Journal reports.
After initial resistance to the measure, Florida's Ron DeSantis became the latest governor to issue a statewide stay-at-home order.
CRISPR Therapeutics warned the pandemic could "severely impact" its business activities and R&D timelines. Story
Los Angeles Times columnist Michael Hiltzik outlined concerns over research touted by French professor Didier Raoult surrounding chloroquine and hydroxychloroquine in patients with COVID-19.
UPDATED: Wednesday, April 1 at 8:32 a.m. ET
With about 50 COVID-19 vaccines in development, it's possible we'll see some ready to use in 12 to 18 months. But there are several potential roadblocks to watch out for, a FiercePharma expert panel warned. Story
After the FDA granted emergency use authorizations for hydroxychloroquine and chloroquine, the Trump administration is pressuring the agency to support use of Fujifilm's Avigan for COVID-19 despite safety concerns, Politico reports.
Because of a "significant surge in demand" following the emergency approval, the FDA is reporting shortages for hydroxychloroquine and chloroquine. The agency also established the Coronavirus Treatment Acceleration Program to help bring treatments to patients as quickly as possible.
As the U.K. prime minister, afflicted by COVID-19, remains isolated in Downing Street, Gilead Sciences is starting two new phase 3 drugs of remdesivir, one of the most promising COVID-19 drugs, at 15 sites in the country. Story
Jazz Pharmaceuticals says that despite the pandemic, it sees "limited financial impact" so far. The company can't rule out a future impact. Its employees are working from home, and Jazz doesn't expect a supply disruption at this time.
Flexion is withdrawing its financial guidance for osteoarthritis-related knee pain drug Zilretta due to the pandemic. It's also outlicensed Zilretta in China, scoring $10 million upfront and up to $32.5 million in milestones.
Cigarette maker British American Tobacco is working with tobacco leaves to make a potential COVID-19 vaccine candidate, Reuters reports.
Roche's Canadian unit is starting an innovation challenge in the country with plans to award grants to promising ideas to help fight the pandemic.
Sen. Richard Blumenthal has put his support behind a Connecticut biotech with a drug candidate he believes could help in the fight, Fox61 reports.
UPDATED: Tuesday, March 31 at 3:41 p.m. ET
Amgen said it doesn’t expect to see any “significant delays” to the development of its highly anticipated KRAS cancer drug, AMG 510, due to the spreading pandemic. The Big Pharma said its potentially pivotal phase 2 study is already fully enrolled with lung cancer patients. Story
Genfit told its investors the same regarding the upcoming unblinding of its phase 3 elafibranor study in nonalcoholic steatohepatitis, or NASH. The company doesn’t “currently anticipate” that COVID-19 will delay its results; however, Genfit has already pushed back the release since its February database lock to gather feedback from the FDA. Story
Akero Therapeutics, however, may not be so lucky. It planned to report top-line phase 2a NASH data from its drug AKR-001 in the second quarter—but it is currently about halfway through collecting biopsies. “The extent to which the COVID-19 pandemic will interfere with collection of the remaining biopsies and data from other scheduled clinical visits, including the safety follow-up visit at week 20, is unclear,” the company said. Story
Qiagen received an FDA emergency authorization for a new SARS-CoV-2 panel, which it describes as the first syndromic test that can rule-out or rule-in the novel coronavirus from among 20 other serious respiratory infections. Qiagen began shipping the tests March 24 under an FDA policy allowing companies to distribute tests to labs as early as possible.
The genomic testing company Color launched a COVID-19 testing lab with the goal of processing 10,000 samples per day—funded initially by private and philanthropic donors.
The FDA and the FTC issued warning letters to two companies for unapproved products, including Corona-cure.com, for selling an infection prevention nasal spray; and Carahealth, for marketing herbal products claiming to prevent or treat COVID-19. The agencies said they are closely monitoring social media and the online marketplace for reports of fraudulent products.
UPDATED: Tuesday, March 31 at 9:25 a.m. ET
Johnson & Johnson CEO Alex Gorsky said he's confident in the COVID-19 vaccine candidate it's picked. "We have very good early indicators that not only can we depend on this to be a safe vaccine base, but also one that will ultimately be effective based on all the early testing and modeling that we’ve been doing," he said in an interview on CNBC. He also promised the vaccine will be affordable on a global level and will be offered on a not-for-profit basis.
A survey conducted by Clinical Research IO March 19-23 across 73 research sites in the U.S., found that 24% of investigators reported “they have stopped enrolling new patients due to patient safety concerns.” Of the 76% remaining, more than a third said they're considering halting recruitment. Story
China is amping up production of several thousands of ventilators, as demand surges across the world due to the COVID-19 pandemic. "China has 21 multifunction ventilator makers and eight of them have obtained the European Union's compulsory CE marking," a government official said during a press briefing. The companies have already signed contracts for 20,000 ventilators, and many more are pouring in every day, China Daily reported.
VBI Vaccines has teamed with the National Research Council of Canada, Canada’s largest federal R&D organization, to develop a pan-coronavirus vaccine candidate targeting COVID-19, SARS and MERS.
India and U.S. governments are in discussions on lifting restrictions on pharmaceutical ingredients exports from India.
South San Francisco startup GigaGen is working on recombinant anti-coronavirus 19 hyperimmune gammaglobulin, a potential treatment made from the plasma of recovered COVID-19 patients. Story
CRISPR pioneer Jennifer Doudna has turned a 2,500-square-foot lab into a facility for running medical tests to detect the novel coronavirus, Stat reported. The lab hopes to be certified by next week and will use Thermo Fisher’s diagnostic test.
Researchers are turning their existing platforms against novel coronavirus. For example, Rensselaer Polytechnic Institute scientists are using a "viral trap" technology; and biotech startup Pinpoint Therapeutics is developing drugs that inhibit PPT1, a pathway targeted by chloroquines. Story
FierceCRO talked to Jonathan Cotliar, chief medical officer for Science 37, a trendy Big Pharma and Big Tech-backed virtual clinical trial company, to assess its response to COVID-19’s challenges. Story
Brii Biosciences, Tsinghua University and 3rd People’s Hospital of Shenzhen are collaborating on developing fully human neutralizing monoclonal antibodies against COVID-19.
UPDATED: Monday, March 30 at 3 p.m. ET
Novartis' Sandoz unit donated 20,000 doses of hydroxychloroquine to the University of Washington for a new COVID-19 clinical trial, the drugmaker said. The study, funded in part by the Bill & Melinda Gates Foundation, will enroll around 2,000 patients with a 14-day post-exposure regimen. Story
The FDA has approved its first plasma therapy from a recovered COVID-19 patient into a critically ill patient at Houston Methodist Hospital. The hospital began recruiting plasma donors on Friday, and the FDA fast-tracked the approval in a matter of days to green-light the procedure. Story
The Allergan Foundation gave $2 million to community groups around the country on the front lines of the COVID-19 fight. The recipients included the New York Community Trust NYC COVID-19 Response & Impact Fund; the Community Food Bank of New Jersey; Orange County, California United Way; Central Texas Food Bank; and the Freestore Foodbank, Cincinnati, Ohio. Story
UPDATED: Monday, March 30 at 11:58 a.m. ET
Johnson & Johnson inked a $1 billion deal with BARDA to advance its leading COVID-19 vaccine prospect. The company is revving up to test the candidate in human clinical studies by September 2020 at the latest, and it's anticipating the first batches for emergency use authorization in early 2021. It's also scaling up manufacturing to eventually supply more than one billion doses. Story
After a U.S. clinical study, Sanofi and Regeneron has started testing their IL-6 inhibitor Kevzara in an ex-U.S. multi-center, double-blind trial. The hope is that the drug could ameliorate the potentially deadly inflammatory complications of COVID-19 in the lung. Story
In an open letter on Saturday, Gilead CEO Daniel O'Day promised that remdesivir will be affordable if it's approved to treat COVID-19. At the same time, it's transitioning the drug's compassionate use to a more streamlined, sustainable approach with “expanded access” programs. Story
The FDA has granted hydroxychloroquine emergency use in coronavirus patients. That means doctors can prescribe it to patients without other options, even though there is no concrete clinical evidence to prove its efficacy. Story
Abbott is launching a rapid coronavirus test able to deliver results in as little as five minutes. The FDA granted the molecular system an emergency authorization, and Abbott said it is ramping up production with plans to deliver 50,000 tests per day starting next week. Story
Novartis' Sandoz started shipping a consignment of 30 million doses of hydroxychloroquine to the HHS for immediate use in controlled clinical studies as part of a commitment to donate 130 million in total internationally.
While the anti-malaria drug could be the Swiss drugmaker's biggest hope against the coronavirus, Novartis CEO Vas Narasimhan said the company is also examining three other drugs—Jakavi for cancer, multiple sclerosis drug Gilenya and anti-inflammatory drug Ilaris—for their potential on complications related to COVID-19, Swiss newspaper SonntagsZeitung reported, according to Reuters.
Fujifilm said it's preparing to increase production of its flu drug Avigan, after Japanese Prime Minister Shinzo Abe expressed support for it as a potential treatment for the new coronavirus and after Chinese science and technology authorities said it's "clearly effective." Story
Thanks to a new legislation, Bayer now plans to hold its annual meeting entirely online for the first time in its history due to the coronavirus. The event will still be held on April 28.
UPDATED: Friday, March 27 at 2:45 p.m. ET
Eli Lilly CEO David Ricks said the drugmaker is working at "lightning speed" to develop a COVID-19 treatment with partner AbCellera. Ricks told Fox News the partners were working on developing an antibody therapy for COVID-19 that could go to clinical trials in early summer. Story
Bluebird Bio has delayed dosing its first German patient with gene therapy Zynteglo until the second half of 2020 due to the novel coronavirus spread. Bluebird has already faced multiple delays on Zynteglo in both territories. After winning its first-ever nod for beta-thalassemia in Europe in March 2019, the actual launch was then pushed back to early 2020 after the EMA demanded changes to commercial drug specification and related manufacturing processes. Story
The National Institute for Health and Care Excellence has drafted three "rapid-response" guidelines for drug delivery amid the novel coronavirus pandemic. The guidelines provide direction on delivering dialysis, anticancer treatments and critical care. Story
UC Davis Health has launched two clinical trials to study treatments for COVID-19, including Gilead Sciences' investigational candidate remdesivir and Sanofi and Regeneron's IL-6 inhibitor Kevzara. Story
UPDATED: Friday, March 27 at 11:24 a.m. ET
Sanofi and Translate Bio are expanding their infectious disease collaboration to include work on a new mRNA vaccine for COVID-19, joining similar efforts by Moderna, CureVac and a partnership between Pfizer and BioNTech. Story
In a response to Mark Senak, a lawyer who works at FleishmanHillard, the FDA said, "Where possible the agency will leverage technology to host meetings allowing for remote participation." But before that, meetings to discuss submissions by GlaxoSmithKline and Intercept Pharmaceuticals have been postponed. Story
HHS Secretary Alex Azar, FDA Commissioner Stephen Hahn and CDER head Janet Woodcock weren't aware ahead of time that remdesivir was receiving orphan status, according to multiple sources familiar with the situation, Axios reported. Gilead has since asked the FDA to rescind the designation, which comes with market exclusivity and other incentives.
A research team from the Massachusetts of Institute of Technology and the University of Colorado Denver suggests that widely used clot-busting stroke drug tissue plasminogen activator (tPA) could help COVID-19 patients with respiratory failure. The therapy was originally developed by Roche's Genentech unit and sells under the brand name Activase.
In an interview with CNBC, Novartis CEO Vas Narashimhan cautioned about hydroxychloroquine and chloroquine as anti-COVID-19 treatments before they're proven to be effective.
The pandemic continues to affect clinical studies. Vertex is pausing enrollment in certain studies and weighing virtual trials where possible. Story
Despite President Donald Trump's claim that testing is going "very well," NPR reports that U.S. testing capacity still trails demand. Trump also said he had a "feeling" that ventilator pleas from New York are exaggerated. New York City mayor Bill de Blasio responded that the president is "not looking at the facts of the astronomical growth of this crisis," according to the New York Times.
U.K. Prime Minister Boris Johnson has tested positive for coronavirus, according to the BBC. He said he will self-isolate in 10 Downing Street, but will "continue to lead the government's response via video-conference as we fight this virus".
Amid a shortage of protective gear, Duke Health has developed a way to clean N95 masks by aerosolizing hydrogen peroxide, which permeates the layers of the mask to kill pathogens.
As officials seek to predict future hot spots, some suggest Miami, Chicago and San Francisco could be vulnerable, MarketWatch reports.
UPDATED: Thursday, March 26 at 3:30 p.m. ET
Merck will donate 300,000 medical masks to frontline healthcare workers in New Jersey. The donation will be directed to New Jersey's Office of Homeland Security and Preparedness, according to NJ.com, to help combat the 4,402 confirmed cases and 62 deaths reported in the state.
The White House under President Donald J. Trump is preparing county-level guidelines for COVID-19 based on low-, medium- and high-risk categories. In a letter to state governors, the administration said the guidelines could be used to institute social distancing measures and other mitigation steps.
In a new survey from GlobalData, 95% of healthcare workers expressed concern about the impact of the novel coronavirus on the future of their companies. The plurality of those respondents called themselves "mildly concerned" about the virus' impact.
A piece of COVID-19 emergency legislation in Canada would allow the government to suspend patents for drugs and devices used to combat the coronavirus. According to Reuters, lobby group Innovative Medicines Canada warned that legislation could go too far in allowing the government to determine which products could be opened to competitors.
U.S. Immigration and Customs Enforcement (ICE) is helping ship stranded Americans back home on planes used to deport undocumented immigrants back to Central America, the department said. The department repartriated 64 U.S. citizens from Honduras on Tuesday.
Italian scientists are investigating a rash of presumed flu and pneumonia cases in late 2019 in Lombardy as possible signs of the spread of COVID-189 from China earlier than initially assumed. Researchers targeted a much higher rate of patients in the last quarter of 2019 as a possible clue to the virus' origins in the country.
Spain said it is locked in a "war" for medical supplies as COVID-19 saps the country's ability to treat a rising case load of patients. On Thursday, Spain's death toll rose to 4,089.
UPDATED: Thursday, March 26 at 9:01 a.m. ET
Fifteen pharma companies—including Gilead Sciences, Pfizer, Novartis and Eli Lilly—have agreed to share their libraries of proprietary molecular compounds with the COVID-19 Therapeutics Accelerator so the organization can look for potential treatments. It's the first step in a partnership between the life sciences industry and the Gates Foundation-backed accelerator program.
Johnson & Johnson is among large drugmakers working on a vaccine, and its chief scientific officer Paul Stoffels told Yahoo Finance the company is “close to selecting a candidate vaccine which we can bring forward for pre-clinical and clinical testing.”
The COVID-19 pandemic is pushing back the expected close for the merger between Mylan and Pfizer's Upjohn to the second half of the year. Previously, the companies expected the deal to close in mid-2020. Mylan is also moving its annual meeting to late June. Story
Meanwhile, Mylan has become the latest drugmaker to say the pandemic won't affect its manufacturing. Story
And Bristol Myers Squibb won approval for multiple sclerosis drug Zeposia, formerly known as Celgene's ozanimod, but the pandemic will delay the rollout. It's one of the launches key to the payoff of a contingent value right granted as part of the two companies' 2019 merger. Story
On the heels of its February approval for migraine med Nurtec ODT, Biohaven has had to embrace digital technologies to keep the launch on track. Story
In the years before the pandemic, the Trump administration reduced the number of CDC personnel in China by more than two-thirds, Reuters reports.
Bluebird bio announced the launch of Zynteglo in Germany back in January, but due to the pandemic, the company now expects the first commercial patient to receive the drug in the second half of the year.
Emergent BioSolutions is exploring using plasma from humans and plasma from horses as possible COVID-19 treatment options, Techcrunch reports.
President Donald Trump and others have praised hydroxychloroquine as a potential COVID-19 treatment, but a rush to secure supply of those drugs is threatening patients who've taken them for years. Nevada is looking to lock down supply by banning use for patients with COVID-19, CNN reports.
VIDEO: COVID-19 patients are to be transported by specially-equipped high-speed train in France's Alsace region, where hospitals are struggling to cope with the number of cases. The patients will be transferred by train to regions where hospitals have greater spare capacity pic.twitter.com/QJmim8hNsr— AFP news agency (@AFP) March 26, 2020
Some off-label medicines for COVID-19 might cause certain patients to die from drug-induced sudden cardiac death, experts warn. It's important to know which patients are vulnerable.
Following its nationwide lockdown earlier this week, India is gearing up for a massive testing effort, Business Today reports. At the same time, authorities are lifting restrictions to allow distilleries and other manufacturers to make hand sanitizer, according to the Economic Times.
UPDATED: Wednesday, March 25 at 3:37 p.m. ET
Following criticism, Gilead asked the FDA to rescind the seven years of marketing exclusivity that comes with the orphan designation for its hopeful COVID-19 treatment remdesivir. Gilead said it aimed to waive requirements for a pediatric study, speeding up its submission. Story
Meanwhile, Mylan is voluntarily giving up its 180-day exclusivity in the U.S. for the generic of AbbVie’s Kaletra antiretroviral, allowing other drugmakers to help meet the potential demand should the HIV treatment prove effective against the coronavirus. A recent NEJM study showed little benefit in severe patients, but others hope to explore the drug’s use in earlier interventions. AbbVie previously relinquished its patent rights.
ASCO is taking its large annual meeting virtual, but the American Diabetes Association—with its confab scheduled for just 10 days later, also at Chicago’s gargantuan McCormick Place—is still going forward. However, the ADA said it is currently considering online options “in an abundance of caution.” Story
According to the WHO and multiple drugmakers, at least 14 repurposed drugs are currently in clinical trials against COVID-19. Here’s our full list.
Biohaven has turned to digital measures—including telemedicine, webinars and social media—to help market its newly approved acute migraine treatment Nurtec ODT, and reach doctors and patients that may be under lockdown. Story
PRA Health launched a mobile app that tracks the symptoms of people who may be asymptomatic for COVID-19, or who have been exposed and are in quarantine. The CRO said it also offers in-depth monitoring and care coordination for those who have been diagnosed. Story
The medical device industry association AdvaMed sent a letter (PDF) to FEMA recommending that the federal government centrally coordinate the distribution of supplies to where they are needed most, including ventilators, diagnostic tests, protective gear and other hardware.
UPDATED: Wednesday, March 25 at 11:02 a.m. ET
Vir Biotechnology, helmed by former Biogen CEO George Scangos, says it has mapped out “multiple antibodies” that can “neutralize” SARS-CoV-2, the virus causing COVID-19. And the San Francisco biotech says it will kick-start a phase 1/2 clinical test as early as this summer, in “3 to 5 months.” Story
Although Moderna’s COVID-19 vaccine is at least a year away from a widespread rollout, the company may provide the vaccine to a few people, which could include healthcare workers, as early as this fall, CEO Stephane Bancel said. Story
Ford Motor Company has outlined "scrappy and creative" plans to re-task some of its manufacturing lines toward the production of much-needed medical equipment including protective face masks, personal air-filtering equipment and ventilator systems for intensive care units. Story
As President Donald Trump continues to tout hydroxychloroquine as a potential COVID-19 treatment—despite wait-and-see advice from health officials—the White House is preparing to roll out a platform to promote the drugs and track patients’ progress. The online platform will likely be used for physicians to upload patient data on how the drug performs in real life. Story
UPDATED: Wednesday, March 25 at 9:00 a.m. ET
Recognizing that a clinical trial might not be accessible to all, the FDA is allowing access to COVID-19 convalescent plasma for use in serious COVID-19 patients through the emergency investigational new drug applications (eINDs) for individual patients pathway. Story
After Gilead Sciences halted individual requests for compassionate use of its investigational remdesivir amid overwhelming demand, a New Jersey man had to travel to the Hospital of the University of Pennsylvania to enter a clinical trial to get the drug.
Remdesivir has won FDA orphan drug designation, which comes with seven years of market exclusivity. But that additional perk has drawn criticism, according to the Financial Times.
UPDATED: Tuesday, March 24 at 3:31 p.m. ET
National Institute of Allergy and Infectious Diseases director Anthony Fauci refused to overly promote anti-malaria drug chloroquine an interview with Fox News host Laura Ingraham. “So I might take one of those drugs, but I would do it within the auspices of a controlled clinical trial,” he said. “I’ve always felt that way.”
FDA's principal deputy commissioner, Amy Abernathy, also cautioned that more clinical data are needed for chloroquine before its approval or wider adoption.
AstraZeneca has pledged a donation of 9 million masks to healthcare workers around the globe. In addition to the gift, the company is advancing its testing capabilities.
President Donald Trump says he wants the U.S. "raring to go by Easter," CNN reports, but health officials say that's not enough time to get a handle on the epidemic.
Several of the leading candidates to treat COVID-19, including chloroquine and AbbVie's Kaletra, have disappointed in early Chinese studies. Story
Gilead Sciences has reassured doctors and patients that it doesn't expect pandemic-related shortages of its blockbuster HIV drugs. Story
Pharma companies have an important role to play during the pandemic, but they need to be thoughtful about the messaging they put out during the crisis, McCann Health global CEO John Cahill says. Story
UPDATED: Tuesday, March 24 at 9:00 a.m. ET
Pfizer CEO Albert Bourla said he was happy when the bickering between his wife and daughter began at home amid the coronavirus lockdown. But he also feels the responsibility to guide Pfizer through the current crisis. “After a couple of weeks there was a fatigue of working from home,” he told The New York Times. “It feels very strange.”
The FDA granted emergency approval to Mesa Biotech's point-of-care coronavirus diganostic, which can give results from throat and nasal swab samples in 30 minutes. Story
Bacillus Calmette-Guérin (BCG) has been used as a tuberculosis vaccine for a century. Now, scientists want to find out whether it could prime the human immune system against other pathogens, including the novel coronavirus. The first of the trials will start this week and will recruit 1,000 health care workers in eight Dutch hospitals.
Despite reports that pharmacies are out of insulin, Eli Lilly says there is no shortage. Instead, wholesalers should still have supply, the company says. Story
Roche's Actemra hasn't been proven to be an effective treatment for COVID-19, but the drugmaker is still bolstering production for potential demand. Story
India is locking down its entire population for three weeks, underscoring drastic measures taken by governments around the globe to fight the pandemic.
President Donald Trump and others have touted hydroxycholoroquine as a potential treatment, and that's creating drug shortages and reckless prescribing, according to reports. Story
Photographer Lara Woolfson talked to WBZ-TV about how what seemed like just another job at a Biogen conference in Boston at the end of February turned into a coronavirus diagnosis for her.
Three Oxford University COVID-19 research projects won financial support from the U.K. government. The three projects include work on an effective vaccine, supporting development of manufacturing processes to produce one at a large scale, plus another on repurposing existing treatments.
Banner Health said a patient had died and his wife was in critical condition after they apparently took chloroquine phosphate—which is also an additive commonly used at aquariums to clean fish tanks—as a possible treatment for coronavirus.
Amgen has committed up to $12.5 million to support U.S. and global COVID-19 relief efforts. The Amgen Foundation will also match donations made by Amgen staff around the globe.
NHS England plans to convert London’s ExCeL center into a makeshift 4,000-bed “field hospital” to prepare for potential peak of the coronavirus epidemic, The Guardian reported.
UPDATED: Monday, March 23 at 3:25 p.m. ET
The pandemic is further disrupting biopharma's R&D operations. Bristol Myers Squibb isn't starting up any new trials for at least three weeks, Reuters reports.
New York, the hardest-hit state in the U.S., is starting a new trial of a plasma therapy on Tuesday, Governor Andrew Cuomo said. The state didn't disclose its pharma partner. New York had recorded more than 20,000 cases as of Monday.
In a rare move, AbbVie is dropping patent enforcement for Kaletra, and HIV med being investigated for efficacy in COVID-19 patients, the Financial Times reports.
Despite frantic efforts to bolster testing capacity, Roche's CEO Severin Schwan said it could be weeks or months before there's broad testing in the U.S.
With all eyes set on the biopharmaceutical industry, industry groups PhRMA and BIO are highlighting the industry's efforts to come up with solutions to the crisis. Story
Researchers at the Feinstein Institutes are starting clinical trials for potential drugs from Gilead, Regeneron and Sanofi.
In its latest move to boost testing, Eli Lilly is offering drive-through testing for doctors and nurses near Indianapolis. Story
The FDA is relaxing inspection requirements for manufacturers making ventilators and other critically needed equipment. Story
UPDATED: Monday, March 23 at 11:21 a.m. ET
Roche's Genentech, in collaboration with the HHS' Biomedical Advanced Research and Development Authority, has won quick a FDA nod to test IL-6 inhibitor Actemra to treat potentially lethal immune overreaction in severe COVID-19 patients. The company will also supply 10,000 vials of Actemra to the U.S. Strategic National Stockpile for potential future use.
The FDA said it will not take action against sponsors and others during the outbreak for failing to adhere to Risk Evaluation and Mitigation Strategy requirements for certain laboratory testing or imaging studies. The agency said those procedures could put patients at risk.
The FDA has also lifted an import alert on India's Ipca Laboratories, a maker of chloroquine, an anti-malaria drug that could hold promise in managing and treating COVID-19, the company said in a disclosure (PDF). Stocks of Ipca, Cadillac Healthcare and Torrent Pharma, which all manufacture the drug, have surged.
Gilead Sciences has suspended emergency access to its experimental drug remdesivir under compassionate use due to "overwhelming demand," the company said Sunday. It's now working with authorities to transition to an expanded access program for a large population. Story
Bristol Myers Squibb has decided to reschedule its planned April 2, 2020 investor day event for a later date.
NICE has developed three COVID-19 guidelines for treating patients in critical care, on kidney dialysis and receiving systemic anticancer treatments. The agency is asking physicians to balance patients' risk of foregoing treatment and the risk of contracting the virus. For example, its guideline on dialysis says that patients with suspected COVID-19 should be assessed to see whether dialysis could be delayed until their COVID-19 status is known.
The FDA has approved its first rapid point-of-care diagnostic for the novel coronavirus, developed by Cepheid, that allows physicians to test a sample for results in about 45 minutes. Story
Just as it's moving full-speed to improve access to coronavirus diagnostics, the FDA is also clamping down on fake at-home tests. While the agency is working with companies to develop legitimate tests, it stressed that it has not yet authorized any COVID-19 product for home testing. Story
Amid supply constraints of ventilators, the FDA is making it easier for companies outside the healthcare industry—such as automakers—to make these critical devices. It's also guiding hospitals to repurpose existing hardwares to serve as makeshift ventilators. Story
Postponement of the Tokyo Olympic Games now looks more likely after Japanese Prime Minister Shinzo Abe admitted that the option is on the table, Reuters reported. Australia's and Canada's Olympic committees have said they will not send their athletes to the event unless it's rescheduled.
UPDATED: Friday, March 20 at 3:20 p.m. ET
The American Association for Cancer Research is rescheduling its annual meeting, originally set for April, to August. The group plans to have a virtual "preview" next month.
The FDA issued a new policy giving manufacturers some leeway in marketing their remote vital sign-measuring devices—such as connected electrocardiograms, electronic stethoscopes, thermometers, blood pressure monitors and other non-invasive hardware—to help keep patients unaffected by the coronavirus out of hospitals and clinics.
Illinois governor J.B. Pritzker plans to issue a "shelter-in-place" order for the entire state starting Saturday, the Chicago Tribune reports.
Following moves by Mylan and Teva to boost supplies for chloroquine, Novartis pledged a global donation of up to 130 million tablets, pending regulatory approvals. The drug isn't approved for COVID-19 and experts are split over its potential. Story
UPDATED: Friday, March 20 at 9:20 a.m. ET
After Bayer donated 3 million chloroquine tablets on Thursday, Mylan and Teva unveiled their own initiatives to make the malaria drug more readily available. Mylan is ramping up production of hydroxychloroquine and Teva announced a donation of 16 million tablets. Mylan believes it can produce 50 million tablets in the coming month. The drug isn't approved to treat COVID-19 but has shown promise, and the FDA is opening up access to it.
Meanwhile, share prices for Indian drugmakers Cadila, Torrent and Ipca jumped, the Economic Times reports. Each of those companies manufactures chloroquine. But the share-price love won't extend to biotech IPOs. Market players figure that window is closed for the foreseeable future. Story
Israel is allowing generics to AbbVie's patent-protected Kaletra to be imported into the country to treat COVID-19 patients, according to reports. The move comes amid calls to limit prices on eventual coronavirus vaccines and treatments—and after the drug stumbled in a trial in COVID-19 patients, though one analyst saw rays of hope in those data.
The FDA on Friday granted Bellerophon an emergency expanded access for its proprietary inhaled nitric oxide, INOpulse, to treat COVID-19 patients. The company's shares were trading sharply up Friday morning before the markets opened.
Johnson & Johnson is seeing two to four times its normal demand for Tylenol due to the pandemic, an executive told Reuters. The company has boosted production globally.
Most FDA workers are working from home, and the agency has stopped routine inspections in the U.S., Stat reports. The agency plans to continue certain "critical" inspections triggered by manufacturing problems.
Meanwhile, the agency is working with industry and others to help advance COVID-19 treatments while also assisting in vaccine R&D.
The pandemic has exposed the U.S.' dependence on the Chinese pharmaceutical supply chain, but Congress could incentivize manufacturing in Puerto Rico through tax changes, an expert wrote in Forbes.
In an interview with USA Today, NIH Director Francis Collins said the U.S. has a "very rough road in the weeks and months ahead" but that all efforts to mitigate the spread of the virus are crucial.
UPDATED: Thursday, March 19 at 3:21 p.m. ET
At a Thursday press conference, President Donald Trump said the government is working to advance therapeutics and that malaria med chloroquine would be available "almost immediately." FDA chief Stephen Hahn said it'll be important to learn more about all potential treatments. Story
Merck KGaA has donated supplies of its multiple sclerosis drug Rebif to researchers in France who aim to conduct a study in patients with COVID-19. Story
Medtronic and GE Healthcare both said they are ramping up production of ventilators to address shortages as the coronavirus continues to spread. Medtronic, maker of the Puritan Bennett brands, said that it has increased its global production by more than 40% to date and plans to more than double its total capacity.
Meanwhile, GE Healthcare said that it was boosting its output of CT scanners, ultrasound devices, mobile X-rays and patient monitors as well, in addition to setting up more ventilator manufacturing lines, increasing shifts and hiring new employees.
Confirming a Wednesday report, German pharma giant Bayer has pledged a donation of 3 million tablets of chloroquine. Story
Italy's death toll from the novel coronavirus pandemic has passed China's fatality count, ABC News reports. Italy has reported 4,205 deaths.
The State Department is set to issue a Level 4 travel advisory, telling Americans abroad to either come home or plan to remain where they are during the pandemic, Politico reports.
At a private lunch three weeks ago, Senate Intelligence Committee chair Richard Burr told a crowd that the pandemic threat was much more serious than government officials warned at the time, a secret recording shows. NPR obtained the clip from an attendee.
UPDATED: Thursday, March 19 at 9:01 a.m. ET
Merck CEO Ken Frazier issued a call to Americans to take social distancing measures seriously so the U.S. can prevent a situation like in Italy, where the outbreak has caused tens of thousands of illnesses and thousands of deaths.
After previously suspending foreign drug facility inspections, the FDA said it would scale back domestic inspections as well.
And how can clinical trial sponsors help keep their research going amid the spreading coronavirus outbreak? Use virtual visits, phone interviews, self-administration and remote monitoring, the FDA says. Story
Biogen will have to delay some Spinraza shipments so it can prioritize patients with COVID-19, Reuters reports. A patient advocacy group said while the shipments are important, a "few weeks delay should not have a huge impact."
The White House previously proposed a $430 million cut to the National Institute of Allergy and Infectious Diseases's 2021 budget, and now it proposes adding that money back into the agency's budget.
Abbott's diagnostic has scored an FDA nod, and the company is planning to ship out 150,000 tests, Reuters reports.
After confusion spread on social media, regulators in Europe and England plan to investigate whether ibuprofen and other over-the-counter anti-inflammatory medicines worsen COVID-19 illnesses, Pharmafile reports.
Following a positive readout for Fujifilm's favipiravir, analysts with Piper Sandler believe Gilead has a strong chance of approval for remdesivir to treat COVID-19.
Piper email just now: "After publishing our note yesterday afternoon, we caught up with Gilead and came away emboldened in our call that the remdesivir clinical data (readout mid-April) will be positive and if that occurs, it should get approved ASAP."— Brad Loncar (@bradloncar) March 19, 2020
UPDATED: Wednesday, March 18 at 3:31 p.m. ET
President Donald Trump sought to allow more testing of investigational drugs in patients with COVID-19 through an executive order, The Wall Street Journal reports. He ran into concerns from the FDA over patient safety. The White House denied the report.
In a bid to expand testing capacity locally, Eli Lilly is offering scientists and equipment to help the Indiana State Department of Health analyze samples. The company isn't accepting payment for the services.
Billionaire Bill Ackman, who has taken up high-profile activist positions in pharma companies in the past, urged the president to shut down the U.S. for 30 days, CNBC reports.
No one defaults, no one forecloses. A 30-day rent, interest and tax holiday for all. The shutdown is inevitable as it is already happening, but not in a controlled fashion which is extending the economic pain and amplifying the spread of the virus.— Bill Ackman (@BillAckman) March 18, 2020
The National Institutes of Health is looking for patients who have recovered from COVID-19 to donate blood for studies on the immune system, according to OneZero staff writer Emily Mullin.
The FDA published new guidance for biopharma companies attempting to conduct clinical trials amid the pandemic.
In a roundup of development efforts, NBC News lined up Sanofi, Regeneron, Roche, AbbVie and Gilead among the major drugmakers exploring using existing medicines across drug classes against COVID-19. Those drug classes include rheumatoid arthritis treatments, an Ebola drug, and HIV meds.
Meanwhile, researchers in Japan are exploring the blood thinner nafamostat as a potential therapy, according to Bloomberg. And EUSA Pharma is now testing whether its IL-6 inhibitor Sylvant can help patients with serious respiratory complications.
Bayer is preparing to donate supplies of old malaria drug chloroquine to the U.S. to help with the fight, Axios reports. Story
President Donald Trump sought to expand testing of investigative therapies in an executive order, but ran into FDA objections over patient safety, The Wall Street Journal reports.
After Chinese officials said Fujifilm's flu-fighting drug favipiravir is effective in COVID-19 patients, the company's shares jumped by 15%, France 24 reports.
Amid global efforts to curb the spread, an analysis from researchers in London found that the U.S. might have to implement "social distancing" measures for months, NPR reports. The analysis seems to be influencing U.S. recommendations on limiting person-to-person contact.
U.S. and Chinese leadership have been in escalating tensions over the pandemic, and now China is threatening to block pharmaceutical exports to the U.S., the Washington Times reports. China is a key producer of many drugs and antibiotics.
Despite the urgent need for a vaccine, a usable shot is at least a year away, most GlobalData readers said in a poll.
Drug cost watchdog ICER has indefinitely postponed meetings for reviews of sickle cell disease and cystic fibrosis drugs. It's also adding three months to its assessment timelines for other medicines.
UPDATED: Tuesday, March 17 at 3:13 p.m. ET
The AbbVie and Allergan megamerger may face a delay if U.S. antitrust regulators request an extension for their review due to the pandemic, Bloomberg reports. Story
Google's Verily released an early version of its COVID-19 testing website, but its capacity was quickly overwhelmed, the New York Times reports. Story
The first recipient of Moderna's vaccine candidate told MSNBC she signed up for the clinical trial because she was eager to help scientists with the response.
CanSino Bio, which previously won approval in China for an Ebola vaccine, is working with Chinese military researchers to start a clinical trial of a COVID-19 vaccine. Filing
As the U.S. government seeks to expand testing capabilities nationwide, an unexpected hiccup has impeded the work, Politico reports. There's a shortage of cotton swabs and other basic supplies needed for the process.
France is warning that it's not just the elderly at risk, The Hill reports. More than 50% of the country's severe cases are in those under 60, according to an official.
New York City mayor Bill de Blasio is considering a shelter-in-place order, but the final decision has not been made, according to the Associated Press.
UPDATED: Tuesday, March 17 at 12:07 p.m. ET
Pfizer is requiring "customer-facing" employees, including its sales team, to work remotely to minimize spread of the virus, CNBC reports. The policy went into effect on Monday.
Novartis has started a response fund with $20 million that will award grants to local communities affected by the pandemic. The drugmaker has also entered the COVID-19 Therapeutics Accelerator and a separate partnership established by the Innovative Medicines Initiative.
Roche has started shipping test kits, and CEO Severin Schwan told Bloomberg that better infection control measures and more testing are needed to control the pandemic. Story
Bayer has fired an employee in China who did not follow quarantine requirements for anyone arriving from abroad, according to a statement on social media app Weibo. Story
Amid the race for treatments, Takeda sees promise in its plasma-based therapy, Bloomberg reports. The treatment uses antibodies from recovered patients, and Takeda believes its medicine could be among the first to win an approval.
Regeneron is zooming ahead with its COVID-19 antibody program. The company has already identified hundreds of virus-neutralizing antibodies and plans to start manufacturing preparations in April. Testing could start in the summer.
The American Enterprise Institute, where former FDA Commissioner Scott Gottlieb is a partner, has started a Twitter account tracking local and state social distancing measures.
Tennessee's self-described "patient zero," a Biogen employee, shared his experience on Facebook. He discussed the stigma of the diagnosis and acts of kindness his family has received. Story
Spectrum Pharmaceuticals has canceled a planned data presentation at the Congress on Pulmonary & Respiratory Medicine. The presentation was scheduled for this week, but the drugmaker will reschedule.
UPDATED: Monday, March 16 at 4:26 p.m. ET
Across the globe, officials implemented more social distancing measures. New York, New Jersey and Connecticut are banning gatherings of more than 50 people. Pennsylvania's governor is ordering a two-week statewide shutdown of non-essential businesses. The European Union is closing borders to non-essential travel. Canada is also closing its borders to non-citizens, with an exception for Americans for now. San Francisco ordered residents to stay inside other than for essential needs.
In a Monday afternoon press conference, President Donald Trump recommended that Americans do not congregate in groups of more than 10.
Meanwhile, the first patient has been dosed in a phase 1 trial of Moderna's vaccine candidate that's being conducted by the National Institutes of Health.
Moderna's stock jumped on the news amid a larger market rout. Major indices in the U.S. closed down 12% to 13%.
Also trading up was BioNTech, whose shares jumped on news of its Fosun Pharma licensing deal covering China rights. The biotech's shares were up about 50% Monday afternoon.
Worried about side effects, South Korea has decided not to use Avigan, an influenza medicine developed by Japan-based Fujifilm Holdings, in its own fight against COVID-19. Japan started testing the med as a COVID-19 treatment earlier this month. Instead, South Korea is using Gilead’s remdesivir, AbbVie’s HIV med Kaletra and a virus suppressing factor known as HzVSFv13, Yonhap News Agency reports.
Bristol Myers Squibb’s much anticipated decision date for multiple sclerosis drug ozanimod is coming up next week, and a Mizuho Securities analyst said he expects it to win approval on time even if the FDA sends its staff to work at home. But shares were down more than 5% Monday afternoon on those worries, Investor’s Business Daily said. BMS said it was looking forward to the March 25 PDUFA date.
Israel’s health ministry fast-tracked approval for several novel coronavirus treatments in hopes of easing the severity of COVID-19 cases in absence of a fully tested therapy, The Jerusalem Post reports. The the three meds—Gilead’s antiviral remdesivir, AbbVie’s Kaletra, and the malaria treatment chloroquine—are all in use in other pandemic-hit countries.
Shortly after quickly authorizing the emergency use of Roche’s COVID-19 diagnostic, the FDA did the same for Thermo Fisher’s real-time PCR test, greenlighting both within 24 hours of receiving the companies’ applications. Thermo Fisher said its high-throughput test can provide results within four hours, including the time needed to prepare the sample and perform the analysis. Meanwhile, the U.S. government financially backed the development of a separate coronavirus test by Qiagen, which Thermo Fisher is pursuing through a $11.5 billion deal.
The co-founder of the Chinese conglomerate Alibaba, billionaire Jack Ma, recently joined Twitter to say that he is donating 500,000 coronavirus test kits and 1 million face masks to help the U.S. effort. The donation comes as the CDC says that reagents and other testing supplies are heading into short supply, and while the rate of new confirmed cases in China has begun to taper off.
UPDATED: Monday, March 16 at 10:17 a.m. ET
Arie Belldegrun, chair of Allogene and former CEO of Kite Pharma, has been diagnosed with COVID-19. In a tweet, he said he felt it was important to share his diagnosis and that "we have to look out for each other and be each other's champion." Story
Pfizer rolled out a five-pronged plan to battle the pandemic, including sharing research tools with the rest of the world via an open-source platform and creating a "SWAT team" of internal experts to accelerate its COVID-19 R&D.
In a remarkable story that broke over the weekend, a German newspaper reported that President Donald Trump attempted to pay German biotech CureVac to make a vaccine exclusively for Americans. FierceBiotech story
Novartis asked its workforce in Europe, the U.S. and Canada to work from home for three weeks, beginning Monday, except for R&D lab staffers, manufacturing workers and field employees. All international travel needs executive approval.
Bristol Myers Squibb stepped up its precautions by asking all employees and contractors who can work at home to do so. It's also restricting visitors to its sites and limiting in-person meetings.
Johnson & Johnson said reports that its HIV drug Prezista could treat the virus are "anecdotal" and "unsubstantiated." The drugmaker has seen no evidence the medicine could treat COVID-19.
Amarin is pulling its sales team off the road for two weeks. The company, which is launching CV med Vascepa, said it's making the move to reduce face-to-face interactions. It'll still provide "digital and internet-based educational materials," plus copay cards and samples.
BioNTech's vaccine candidate, which is set to enter the clinic in late April, has attracted licensing attention from Pfizer. Meanwhile, the biotech landed $135 million from Fosun Pharma in a deal that focuses on China rights. Story
Sanofi and Regeneron kicked off their global clinical trial program for Kevzara in patients with severe COVID-19. Regeneron has initiated a phase 2/3 trial in the U.S., while Sanofi is leading efforts elsewhere. Story
Hong Kong started a trial of Gilead's remdesivir. Studies are underway in China, with results expected next month.
At Sunday night's debate for Democratic presidential candidates, former Vice President Joe Biden and Senator Bernie Sanders presented their ideas for fighting the crisis. Biden said he'd make sure states have drive-through testing capabilities and plan for additional hospital beds, while Sanders wants to ensure that patients wouldn't have to worry about paying for their care.
Amid the chaos, Sanofi's production and supply chain has been uninterrupted. The company doesn't expect shortages at this time, a spokesman told Reuters.
In Sunday guidance, the CDC said it recommends against gatherings of more than 50 people for the next eight weeks.
UPDATED: Friday, March 13 at 9:07 a.m. ET
AstraZeneca has implemented employee travel restrictions and many of its staffers are working from home. The company is restricting visitors, and on the scientific side, it's "taken appropriate measures to ensure continuity and mitigate any impact to our research and development programs."
President Donald Trump's European travel restrictions have forced Novartis to adjust a supply chain. The company had been using passenger aircraft to ship immune cells from European cancer patients to labs in New Jersey, but that'll be affected by the clampdown. Instead, the company found "alternate options to mitigate potential interruption of supply," Reuters reports.
More broadly, despite the president's claim the restrictions won't affect trade, expert Ken Roberts writes in Forbes the measure could result in supply chain bottlenecks for products like vaccines. A lot of freight travels in the bellies of passenger planes, he wrote, and schedules for those flights will have to change.
The FDA granted its first emergency approval to a commercially developed coronavirus test, for use on Roche’s fully automated, high-throughput cobas systems, which are widely available in hospitals and laboratories. The diagnostic is expected to increase the nation’s testing capacity by tens of thousands of tests per day—and the FDA said it authorized the test within 24 hours of receiving Roche’s application.
The Marriott Long Wharf, where Biogen held a meeting that resulted in dozens of sicknesses, is closing for an undisclosed amount of time, NBC Boston reports. In Massachusetts alone, the meeting has spawned 82 confirmed or presumptive cases out of 108 total.
Former FDA commissioner Scott Gottlieb has been vocal about what's needed to respond to the virus for weeks, and on Thursday he called for even small gatherings to be postponed.
2. Business is leading the way on mitigation and social distancing, filling a void left by policy makers. But shutting down NBA games is not enough. This must be practiced in places large and small. Small gatherings, parties, all should be postponed for the next month or two 7/10— Scott Gottlieb, MD (@ScottGottliebMD) March 12, 2020
Roche's diagnostic approval could ease some major bottlenecks still interfering in the U.S. pandemic response. Despite the Trump administration's claims that novel coronavirus tests are widely available, that's not the case in practice, the New York Times reports.
In another move to widen testing, the FDA gave the New York State Department of Health the authority to allow certain labs to proceed with validated COVID-19 testing without any federal approval or regulatory submissions. Instead, those labs would interact solely with the state health department.
Meanwhile, the Trump administration named a “testing czar” to coordinate diagnostics efforts between HHS, FDA and the CDC. According to a report by Politico, Admiral Brett Giroir, head of the U.S. Public Health Service and HHS assistant secretary for health, will also work with state and local authorities to speed up testing.
China is now restricting some incoming flights, Time reports. The country was the center of the novel coronavirus outbreak early, but now that the pandemic has spread beyond its borders, China is hoping to limit new cases.
UPDATED: Thursday, March 12 at 9:01 a.m. ET
Genentech reports that two people who were at its offices in South San Francisco earlier this month have since tested positive. The company is encouraging employees to work from home if they can, plus it has canceled large meetings and is restricting travel and visitor access.
ASCO, the massive cancer meeting set for May 29 to June 2, is considering changing to a digital format if needed. No final decisions have been made.
The Massachusetts case count tied to Biogen's late-February meeting in Boston has climbed to 77 on Wednesday. The number was only 7 higher than on Tuesday, compared with a climb of more than 30 new cases the day before. That total excludes cases that have been recorded elsewhere, such as those in Indiana and North Carolina.
Meanwhile, Biogen has entered a COVID-19 development and manufacturing pact. It's signed on to develop and manufacture clinical supplies of Vir Biotechnology's antibodies against the novel coronavirus. Story
After a Bayer employee in Creve Coeur underwent testing, the tests came back negative, the St. Louis Post-Dispatch reports. The company has reopened the site near St. Louis.
Amid the rising case count, experts are hoping to #FlattenTheCurve to reduce peak demand on healthcare resources. Social distancing and proper handwashing are two key components.
Our #FlattenTheCurve graphic is now up on @Wikipedia with proper attribution & a CC-BY-SA licence. Please share far & wide and translate it into any language you can! Details in the thread below. #Covid_19 #COVID2019 #COVID19 #coronavirus Thanks to @XTOTL & @TheSpinoffTV pic.twitter.com/BQop7yWu1Q— Dr Siouxsie Wiles (@SiouxsieW) March 10, 2020
The U.S. Army has reached a deal with Gilead Sciences to provide remdesivir to service personnel who have confirmed COVID-19 infections, Military Times reports. Gilead is providing the antiviral drug at no cost. Separate from the military's deal, two cruise ship passengers were among the first to receive the drug as part of an NIH trial, People reports.
Contract developer and manufacturer WuXi AppTec has resumed operations in Wuhan, meaning all of its facilities in China are operational once again. The company will ramp up activities at the Wuhan site in the "coming days and weeks."
South Korea's Celltrion is among those racing to develop a treatment. The company aims to enter human testing in 6 months, chairman Seo Jung-jin said Thursday, according to the Korea Herald.
Amazon is in discussions with the Gates Foundation about how it could help with the COVID-19 testing effort in Seattle, CNBC reports.
UPDATED: Wednesday, March 11 at 1:09 p.m. ET
As cases continue to climb, and due to "alarming levels of inaction," the World Health Organization on Wednesday said COVID-19 can be declared a pandemic.
The outbreak has made its way to Eli Lilly's headquarters. A day after the drugmaker told certain staffers to work from home, an employee for the drugmaker in Indianapolis has tested positive, Indianapolis' RTV6 reports. Lilly employs about 11,000 people in the city, according to the report.
Bayer is shutting two sites in New Jersey and two sites in Missouri, NJBiz reports. Earlier this week, an employee for the company was being tested for the novel coronavirus.
The list of conference cancellations or postponements continues to grow, with large oncology confab AACR joining those ranks. Cancellations include infectious diseases meeting CROI, asthma, allergy and immunology meeting AAAAI, plus AAD in dermatology and ACC in cardiology. AACR said it's canceling its annual event to reschedule, but it didn't immediately provide new dates. Story
It's not just industry and academia affected by the outbreak. Regulators are also grappling with how to respond, and the FDA has decided to stop inspections of foreign drugmakers. That could delay approvals for products made in plants outside of the U.S. Story
A high-profile opioid trial in New York won't proceed as scheduled, either. The trial was set to start on March 20 but has been indefinitely postponed. Defendants include Johnson & Johnson, Allergan, Teva, Purdue, Endo and Mallinckrodt. Story
Gilead's remdesivir, which authorities have said is one of the most promising potential treatments, has already been deployed in Washington state, CDC director Robert Redfield said Tuesday. The state has been battling a cluster of cases and has reported 23 deaths.
Biogen's late-February meeting in Boston is now associated with about 80 cases, and the Boston Globe published some new details. After the meeting, Biogen notified the Massachusetts Department of Health that about 50 attendees were showing flu-like symptoms. The department refused to test those employees because of strict federal testing guidelines at the time, according to the report.
Sanofi and Regeneron are gearing up to study arthritis med Kevzara in certain patients. The news comes after a rival immunology med, Roche's Actemra, has attracted attention for its ability to possibly help patients with lung inflammation. Story
As the case count climbs in the U.S., federal authorities are planning to provide guidance to help stop the virus' spread in Washington state, California, New York and Florida, Reuters reports.
Novartis is the latest drugmaker to publicly state it doesn't anticipate supply chain disruptions.
A visitor to the Washington, D.C. offices of pharma trade group PhRMA tested positive, prompting the group to close the office for the rest of the week for a deep cleaning. Story
Analysts with RBC Capital Markets are warning that the outbreak could hurt enrollment for clinical trials. They highlighted the partnership of Gilead and Galapagos, plus Intercept and Corbus among companies whose trials may be affected. Story
HHS is throwing its support behind a novel coronavirus diagnostic from Hologic that can process up to 1,000 samples per hour and deliver results within three hours. Story
UPDATED: Tuesday, March 10 at 10:16 a.m. ET
Merck & Co. and Roche are the latest drugmakers to roll out work-from-home policies, joining many others in the industry that have taken steps to prevent spread of the virus.
Merck is instructing certain employees in Montgomery County, Pennsylvania, to telework "until further notice" to reduce daily staff at the site and cut transmission potential, according to the Philadelphia Business Journal. Merck employs about 10,000 people at the site, but it wasn't immediately clear how many would be working from home.
In Spain, Roche is telling its 1,200 employees there to work from home, Reuters reports. The company says it'll maintain normal operations and keep delivering medicines.
A Bayer employee at the company's site in Creve Coeur, near St. Louis, is being tested for COVID-19, KMOV reports. In response, the company is closing the site until further notice.
South Korea has been among the hardest-hit countries, and the outbreak has ground the local biopharma industry to a halt. Companies have put off planned IPOs, stopped marketing activities, Pulse News reports. They're also struggling to recruit for clinical trials, too, as patients are wary about traveling to hospitals.
The number of cases in Massachusetts tied to Biogen's meeting in late February increased again to 32.
Despite the urgent need for vaccines and therapies, a vaccine is at least 18 months away, MIT Technology Review reports. There's a lot of hype over Moderna's mRNA candidate, which is the farthest along, but the technology is still unproven, the publication points out.
Novavax scored an initial $4 million contribution from the Coalition for Epidemic Preparedness Innovations for early work on a vaccine candidate. The biotech is currently reviewing several recombinant nanoparticle vaccines in animal models.
Meanwhile, the global race for treatments got a funding infusion from the Bill & Melinda Gates Foundation, Reuters reports. The foundation pledged $125 million to the COVID-19 Therapeutics Accelerator, which will fund promising new or repurposed drugs to combat the virus.
After complaints that the CDC is not being transparent with testing data, the American Enterprise Institute is stepping in. Former FDA commissioner Scott Gottlieb, who is now a resident fellow at AEI, tweeted that their testing tracker is just getting underway.
At @AEI we started a twitter handle @COVID2019Tests to track lab testing capacity on a per patient, per day basis. While our initial list is incomplete, we’ll update daily as more labs report about their screening capacity. If you have updates, please email [email protected] pic.twitter.com/HkHjyQrPTd— Scott Gottlieb, MD (@ScottGottliebMD) March 9, 2020
Complicating companies' usual clinical data releases, the American Academy of Allergy, Asthma & Immunology has canceled its annual meeting scheduled for this weekend in Philadelphia. Blueprint Medicines is holding an investor call to discuss new data on Ayvakit on Monday morning. Stay tuned for more to follow.
The American Academy of Dermatology has canceled its upcoming annual meeting, as well. The event had been scheduled for March 20 to March 24 in Denver. The two cancellations followed the American College of Cardiology's decision Monday to fold its annual meeting scheduled for late this month.
The National Association of Manufacturers, which includes some biopharma companies, released a set of policy recommendations to deal with the outbreak in the U.S. They include tax credits for employers of quarantined workers, and tax credits for companies who pay workers during temporary business closures.
UPDATED: Monday, March 9 at 10:33 a.m. ET
Biogen's late-February management meeting has spawned at least 23 cases so far, and attendees later moved on to the Cowen & Co. investment conference across town and the ACTRIMS medical meeting in Palm Beach. The company has told all its employees to work from home.
Takeda, Eli Lilly and Amgen each rolled out strict new policies calling for little to no travel and widespread WFH.
Lilly is asking U.S. employees to work at home if possible, and it's restricting U.S. travel, too. "We have a unique responsibility to ensure continuity in our manufacturing facilities and R&D labs. By minimizing staff in our offices, we are reducing risk of inadvertent transmission to workers who don’t have the option of continuing to do their important work from home," the Big Pharma said in a statement. The company hasn't put a timeline on its restrictions and says its policies will change as the situation on the ground shifts.
Takeda employees will be working from home where possible, "starting immediately," the company said Sunday. The Japan-based drugmaker is also canceling all international and domestic travel "by any means of transport other than a private vehicle" through May 31. As for meetings, the company is "strongly discouraging organizing or attending any internal or external large gatherings" through the end of May, too.
Amgen suspended international travel and all travel to medical congresses and other large events through April 17. The company doesn't appear to have ordered employees to telecommute, but it's "supporting our staff, including those working from home" and "leveraging virtual meeting technology." It's also stepped up cleaning at its company facilities and visitor screening, too.
With all the travel restrictions across the industry—and at top research hospitals—it's little surprise that the American College of Cardiology would cancel its annual meeting later this month. It issued an FAQ for would-be attendees with need-to-know info about refunds and the like, but also noted that parts of the program will go virtual.
Riding a wave of "unconfirmed media reports" that HIV medicine Kaletra is effective in treating COVID-19, AbbVie is working with global authorities to determine whether the drug could be used in the outbreak. AbbVie said it could not confirm Chinese reports that Kaletra is effective given its inability to access clinical information in that country.
Meanwhile, Amgen struck a reassuring note on the supply chain side, saying that it doesn't expect shortages of its products and that it's taking steps to "mitigate" any potential problems with raw material supplies. Story
Likewise, Vertex said it's "highly confident" that it will be able to continue supplying its range of CF meds and that COVID-19 hasn't affected its launch of Trikafta, its latest debut. "We are well-prepared from a business continuity perspective, with ample supply to meet commercial needs well into the future,” the company said. It also elected to forego the Cowen conference where some industry execs and market watchers may have been exposed.
With diagnostic testing proving a major hurdle in fighting COVID-19's spread, the Bill & Melinda Gates Foundation has made new commitments to respond in its hometown of Seattle, including new public health funding and a project to provide at-home testing kits. As FierceMedTech reports, the test packages will include nose swabs that can be mailed to the University of Washington (UW) for analysis, with the goal of processing thousands of tests per day.
Congress has passed an emergency coronavirus spending bill, but not without a battle over drug pricing for potential therapeutics and vaccines that benefited from public research. Story
Looking to stymie opportunistic drugmakers looking to turn a profit on the crisis, the FDA warned seven companies to stop selling fraudulent COVID-19 treatments. "We’re prepared to take enforcement actions against companies that continue to market this type of scam," FTC Chairman Joe Simons said in a release.
And researchers continue to attack the virus from various angles. At least one antiviral is new to the testing scene; AIM ImmunoTech said the National Institute of Infectious Diseases in Japan will begin testing the company's antiviral drug Ampligen. The drug previously showed activity against the original SARS coronavirus in animal models, AIM said.
Other scientists are digging deeper into the virus itself for clues that might aid drug developers. One team of researchers from China, for instance, is providing a map of the human receptor angiotensin-converting enzyme 2 (ACE2) and the entry point it provides to COVID-19. The virus hijacks that protein to enter cells, the scientists found. It's one of two virus maps released in last week that could help those searching for treatments. Story
UPDATED: Friday, March 6 at 9:49 a.m. ET
As Congress debates an $8.3 billion emergency spending bill on COVID-19 response, industry lobbyists have successfully nixed language in the legislation that would potentially infringe on the intellectual property rights of vaccines deemed too expensive, Politico reported. Pharma lobbyists helped kill language targeting potential vaccines that politicians find too expensive and allowing the government to delay development of those vaccines. President Donald Trump signed that bill into law Friday morning.
Materia Medica, a Chinese medical research institute, is partnering with Canadian biotech Cyclica to attempt to repurpose antiviral drug candidates as targeted treatments for COVID-19. The partners said they planned to use artificial intelligence to help identify possible repurposing candidates, forgoing the time and expense needed to develop novel treatments.
Pfizer is hoping to get its hands on a vaccine for COVID-19, partnering with mRNA biotech BioNTech, U.S. Chief Scientific Officer Mikael Dolsten told Reuters. Dolsten, who met with Trump this week with other Big Pharma heads to talk about industry response to the virus, told the news wire: “We will share some of our thoughts with BioNTech also on what they do on COVID-19 and evaluate whether there are things that could merit to do together.” Link
After a management meeting in Boston, Biogen reported three confirmed cases of COVID-19, potentially providing a preview of new crackdowns on travel across global pharma. Drugmakers had previously limited travel only to established affected areas, but those rules could change now that employees are getting hit closer to home. Link
Biogen has started restricting employee travel, but it isn't alone. GlaxoSmithKline, Bristol Myers Squibb, Roche, Mylan and other companies have updated travel policies and are limiting where employees may travel. Story
Looking to get ahead of a U.S. testing shortage, two of the nation’s largest clinical testing providers are launching their own assays for the novel coronavirus with the FDA's blessing. LabCorp began making its internally developed PCR test available Thursday, for use with respiratory samples such as saliva, washes, and nasal or oral swabs. Link
With the fears of coronavirus spreading, dozens of U.S. blood drives nationwide have been called off, threatening a shortage of available blood nationwide, according to Kaiser Health News. “It’s definitely a threat to the blood supply,” said Dr. Louis Katz, who is leading the response to the outbreak for AABB, a nonprofit transfusion medicine association. “We’ll lose donors that are afraid to come out in public.” Link
UPDATED: Thursday, March 5 at 10:39 a.m. E.T.
Investigators in the Seattle area have started recruiting trial participants for an early study of Moderna's vaccine candidate, The Wall Street Journal reports. The trial will enroll 45 adults aged 18 to 55 who don't have certain health conditions. To reach a clinical trial in just two months is "unprecedented," senior investigator Lisa Jackson told the newspaper.
Meanwhile, Moderna CEO Stephane Bancel told Business Insider his company will take a "thoughtful" approach to pricing the vaccine if it gains approval. Moderna wouldn't price the shot higher than other respiratory virus vaccines, he added.
Former FDA commissioner and current Pfizer board member Scott Gottlieb said big lab companies such as LabCorp and Quest Diagnostics need to join the diagnostics fray as the virus spreads in the U.S.
1/n On #coronavirus testing: The nations big clinical labs meet in Washington today for a convention and their CEOs are in town meeting with federal elected leaders. This is their moment. They ought to step up. They may be judged by what they now do.— Scott Gottlieb, MD (@ScottGottliebMD) March 4, 2020
By Thursday morning, Quest Diagnostics was saying it would roll out a COVID-19 test "to supplement public health response" in the U.S. The company will be able to receive specimens and start testing on Monday, it said, pending review under the FDA"s emergency authorization program.
Joining the likes of Pfizer and Merck, Germany's Merck KGaA said it's following the situation closely and can't yet predict how the global outbreak will affect its business—though it does expect a 1% bite out of 2020 net sales, with most of the pain in Q1.
Meanwhile, the House of Representatives passed an $8.3 billion spending bill to fight the outbreak, WSJ reports. The bill includes more than $3 billion in funding for R&D to work on new drugs, and $2.2 billion for the CDC to help combat the spread of COVID-19. It also features $300 million in funding for the government to buy potential vaccines and drugs. The legislation now goes to the Senate.
The U.S. death toll has grown to 11 as California reported its first fatality from the novel coronavirus and Washington state recorded its tenth, The Hill reports. California now has 53 confirmed cases, and Governor Gavin Newsome declared a state of emergency.
After export pharmaceutical restrictions from India raised fears of shortages, an official says those restrictions are only temporary. Story
UPDATED: Wednesday, March 4 at 4:43 p.m. E.T.
Takeda is joining its large pharma peers in the hunt for a therapeutic or vaccine. The company says it's working on a new plasma-derived therapy, and it's scanning its existing portfolio of medicines to see if any might hold promise against the novel coronavirus.
Arcturus Therapeutics has teamed up with the Duke-NUS Medical School to work on a novel vaccine for Singapore. If successful, the vaccine could be deployed quickly to millions of people at a price lower than other mRNA vaccines, CEO Joseph Payne said.
Meanwhile, China is recommending doctors use Roche's Actemra to treat patients with lung damage. The drug won U.S. approval back in 2010 as a rheumatoid arthritis treatment. Roche donated $2 million worth of the drug to help the fight against the virus. Story
In the U.S., 9 patients have died from COVID-19, all in Washington state, CBS News reports. New York City confirmed a second case Tuesday, and soon after, his family and neighbor tested positive, taking the case count there to 6. It had been the first case of community spread in the state, and health officials were working to identify anyone who might have come in contact with the patient or his family members.
San Francisco has only been provided 250 test kits, Bloomberg reports, and the city's mayor London Breed wrote to Vice President Mike Pence the lack of kits is a "national disgrace."
With the case count set to grow in the U.S., "mitigation" strategies will be needed to fight the outbreak, two experts wrote in The Wall Street Journal. Former FDA commissioner Scott Gottlieb and former director of medical and biodefense preparedness at the National Security Council Luciana Borio say "social distancing" measures will need to be put into place.
There were 2,223 new cases in the last day worldwide, WHO reported Wednesday, and 2,103 came from outside of China. While the new cases have slowed significantly in China, the outbreak is gaining steam elsewhere, the numbers show. Four countries reported their first cases, the agency says.
Italy has been among the hardest hit countries, and Prime Minister Giuseppe Conte is moving to close all schools and universities for two weeks, according to reports.
UPDATED: Tuesday, March 3 at 10:58 a.m. E.T.
Drugmakers continue to review their supplies and supply chain, and Eli Lilly says it doesn't expect shortages. The company doesn't source active pharmaceutical ingredients from China, and the company's insulin manufacturing facilities in the U.S. and Europe have not been affected. Story
India is restricting exports of dozens of drugs and APIs. In an official notice, the government didn't give its reasoning, but an official told Reuters the products might still face shortages. Shortages could become "acute" if the outbreak persists. Story
Global finance officials are preparing their response to minimize economic fallout, Reuters reports. Group of Seven officials are meeting Tuesday to discuss their approach, but the effort isn't likely to include new spending or rate cuts. Meanwhile, President Donald Trump early Tuesday called for a rate cut from the Federal Reserve, and the Fed announced the cut late Tuesday morning.
There are now more than 10,000 cases of COVID-19 outside of China, with South Korea, Italy and Iran hardest hit in that group. In the U.S., the outbreak has made its way to at least 13 states as Georgia reported its first cases, The Wall Street Journal reports.
But reports of new cases have slowed in China, as that country on Tuesday said it saw the lowest number of new cases in a day—125—since it started daily updates.
UPDATED: Monday, March 2 at 4:21 p.m. E.T.
Drugmakers are meeting with President Donald Trump Monday to discuss ongoing R&D efforts, according to a tweet from the president. CEOs of Gilead, GlaxoSmithKline, Moderna, Novavax and CureVac will attend, CNBC's Meg Tirrell reports, plus R&D chiefs of Sanofi Pasteur, Johnson & Johnson and Pfizer.
The Biotechnology Industry Organization has selected George Scangos, former Biogen CEO who is now chief exec at Vir Biotechnology, to lead its COVID-19 response. Story
The FDA will allow certain academic institutions and other institutions to develop and operate their own tests for the virus. The decision follows limited testing in recent weeks that has generated significant criticism of the U.S. government's initial response. Story
Another drugmaker has warned of the risk of the outbreak to financial results. After Pfizer said the outbreak could hurt its operations, Merck said it expects the outbreak in China to have an adverse effect on first-quarter sales. It doesn't expect the impact to be material.
Following reports of new cases around the world, former FDA commissioner Scott Gottlieb tweeted that we'll soon see "mitigation steps" that could disrupt daily life in places such as northern California and Washington state.
People shouldn’t be alarmed as mitigation steps start to unfold (school closings, cancellations, transportation restrictions, other measures). The tools of public health have been long rehearsed for these threats. Our public health officials will deploy them with care and effect.— Scott Gottlieb, MD (@ScottGottliebMD) March 2, 2020
The outbreak in the U.S. has gained steam. Officials in Washington, Rhode Island, California, Oregon, Florida and New York reported new cases. And two patients in Washington died, becoming the first U.S. victims. Update
There are now confirmed or presumptive cases in 10 states, according to the CDC. The death toll in Washington climbed to 6 on Monday, the Wall Street Journal reported.After a steep decline for stock markets last week, U.S. stocks partially recovered Monday. The Dow Jones Industrial Average was closed up nearly 1,300 points.
UPDATED: Friday, Feb. 28 at 11:22 a.m. E.T.
Pharma companies such as Sanofi, AstraZeneca, Novartis and more are limiting travel, representatives told FiercePharma. GSK is also restricting non-essential travel to Italy and South Korea. Story
In its new annual report, Pfizer said it's difficult to predict how the outbreak will play out, but a "continued spread ... could adversely impact our operations" including manufacturing, market and clinical trials. The outbreak could affect financial results, the drugmaker said.
Stocks across the world continued their slide Friday, and this week is set to be the worst since 2008, The Wall Street Journal reports. Economists are increasingly worried about the outbreak triggering a recession, according to Axios.
Several countries reported their first cases with ties to Italy, WHO officials said at a press conference Friday. Still, many of the cases are linked to a known source, suggesting the virus is not yet "spreading freely" in those communities.
The FDA reported a shortage of one medication tied to the outbreak, but didn't identify the product or manufacturer. Story
UPDATED: Thursday, Feb. 27 at 11:20 a.m. E.T.
President Donald Trump has selected Vice President Mike Pence to lead the U.S. coronavirus response. The move followed a report that he might tap a "coronavirus czar," but Trump said Pence is not a czar because he's a member of the administration. Trump said Pence's experience during a HIV outbreak in Indiana qualified him for the job. Former FDA commissioner Scott Gottlieb had been under consideration, Politico reported Wednesday.
On Wednesday, the U.S. confirmed its first coronavirus case from an unknown origin, Bloomberg reports, suggesting the virus is already circulating in some American communities. The case was detected in California.
As the threat grows outside of China, the world is at a "decisive point," WHO's Tedros Adhanom Ghebreyesus said at a Thursday news conference. In the last 24 hours, 7 countries have reported their first cases. He urged that this is the "window of opportunity" for those countries to contain the outbreak.
Despite not being selected as coronavirus czar, Gottlieb is still involved. He tweeted that urgent action is needed to prevent an epidemic in the U.S.
A therapeutic is possible and can be a brake on this virus. The summer may limit its spread. An epidemic in U.S. is far from inevitable. We can confront and conquer this virus. We can limit its impact on American lives. But we need to face it aggressively now. The moment is now.— Scott Gottlieb, MD (@ScottGottliebMD) February 27, 2020
Meanwhile, Gilead has started two large phase 3 studies of its remdesivir in countries with a high number of cases. A WHO expert has said the drug is the most promising to date.
Amid fears of supply chain disruption, Novartis' Sandoz pledged "stable" pricing for certain generics and antibiotics. Story
South Korea confirmed more than 500 new cases Thursday, CNBC reports, passing China as the country with the most new cases.
As the situation escalates, Japan's Prime Minister Shinzo Abe is moving to close all schools in the country for most of the month of March.
UPDATED: Wednesday, Feb. 26 at 8:14 a.m. E.T.
The Centers for Disease Control expects the virus to circulate around communities in the U.S., The Wall Street Journal reports. So far, health systems have been able to handle the limited number of cases, but if the outbreak spreads through the States, "the disruption to everyday life might be severe,” an agency official said.
President Donald Trump, who has defended his administration's response to the outbreak, plans to have a 6 p.m. press conference at the White House.
Others aren't as fond of the Trump administration's response. At Tuesday's debate, Democratic presidential candidates blasted the administration's preparation efforts and Trump's earlier prediction the virus would "go away" in April, MarketWatch reports.
Meanwhile, the National Institutes of Health has launched the first trial of Gilead's remdesivir in the United States. Investigators at the University of Nebraska Medical Center plan to study the medicine in adults who've been hospitalized with the novel coronavirus, Pharmafile reports.
Another biopharma player is getting involved in the R&D effort. Tonix Biopharmaceuticals has teamed up with Southern Research on its vaccine candidate TNX-1800.
UPDATED: Tuesday, Feb. 25 at 9:07 a.m. E.T.
While drugmakers around the world work on potential treatments and vaccines, the World Health Organization sees the most promise in Gilead's remdesivir. An assistant director-general, Bruce Aylward, said there's "only one drug right now that we think may have real efficacy and that's remdesivir," as quoted by CNN. China plans to release results from a 761-patient study of the drug candidate on April 27, Bloomberg reports.
Despite the high recorded number of cases, the world is "just seeing the tip of the iceberg," former FDA commissioner Scott Gottlieb said in a CNBC interview. Officials are only "detecting a small fraction" of the total cases in countries such as Italy, South Korea, Iran and Japan, he added, while testing in the U.S. is limited so far.
Moderna has become the first company to ship clinical supplies for a completely new drug or vaccine candidate. The company shipped its mRNA-1273 vaccine candidate to the National Institute of Allergy and Infectious Diseases for a phase 1 trial that could start by April. Story
New research efforts are popping up seemingly on a daily basis. With a $115 million contribution from the China Evergrande Group, Harvard University scientists have teamed up with the Guangzhou Institute of Respiratory Disease on novel coronavirus work. Story
WuXi Biologics and Vir Biotechnology entered a fresh pact on Tuesday, as well. Under their deal, WuXi will be responsible for cell-line development, process and formulation development and manufacturing early clinical supplies of Vir's drug candidates. If any drugs win approvals, WuXi gets China marketing rights while Vir retains rights to sell the meds elsewhere.
UPDATED: Monday, Feb. 24 at 9:36 a.m. E.T.
As the COVID-19 case count climbs outside of China, the outbreak is nearing pandemic status, the Washington Post reports. New cases are cropping up in South Korea and Singapore, while Italy has become the most affected country in Europe. The WHO hasn't yet declared a pandemic, but it has started issuing more "ominous" language around the outbreak, according to the Washington Post.
GlaxoSmithKline is entering a new coronavirus collaboration. China's Clover Biopharmaceuticals is testing a protein-based vaccine candidate along with GSK's pandemic adjuvant system. Clover has a large manufacturing presence and could scale up production if the work succeeds, GSK said. Story
The Dow Jones Industrial Average plummeted more than 800 points on Monday morning on reports of new cases outside of China, the Wall Street Journal reports. Airlines and other travel stocks suffered the most.
HIV patients in China might soon run out of their medicines and don't know where to refill their prescriptions due to quarantines and lockdowns, the United Nations warned. Officials pledged a "close partnership" to ensure patients can access medicines.
UPDATED: Friday, Feb. 21 at 10:37 a.m. E.T.
Fourteen passengers of the Diamond Princess cruise ship infected with COVID-19 were flown back to the U.S. this week against recommendations from the Centers for Disease Control and Prevention, according to the Washington Post. Earlier this week, Japan ended its quarantine of the ship, which reported 621 confirmed infected passengers.
Of 13 Diamond Princess evacuees taken to Nebraska, 11 have been confirmed positive for COVID-19 and are being held in quarantine at the University of Nebraska Medical Center, according to USA Today.
The coronavirus outbreak is now hitting Chinese jails, where about 500 cases have been reported so far, Reuters reported. Of those, 234 cases were reported outside of Hubei Province––the epicenter of the COVID-19 outbreak––ending a 16-day decline of new cases outside that province.
With the FDA suspending inspections in China due to coronavirus, GlobalData warned the move could lead to global drug shortages. "China is highly integrated within the global economy and has impressive transportation networks, which means that supply chain disruptions go far beyond regional concerns, GlobalData's infectious diseases analyst Angad Lotay said. "With the coronavirus epidemic still on the rise, global supply chains are being disrupted with many industries having to draw up contingency plans."
UPDATED: Thursday, Feb. 20 at 8:52 a.m. E.T.
Besides big-name drugmakers like J&J, Sanofi, Gilead Sciences and Regeneron, a number of small biotechs are taking on the novel coronavirus challenge. AbCellera is trying to identify antibodies in patients who recovered from COVID-2019 illness, a first step toward making a biologic treatment, NPR reports. And RNAi-focused biotech Sirnaomics is hoping to use the gene-silencing technique to turn off key genes in the virus. It's testing 150 of them to determine which are the best targets.
Meanwhile, BioCryst Pharmaceuticals is looking to repurpose its galidesivir, which works by interfering with viral replication. It's shown activity against a variety of viruses, Reuters reports, and the company has teamed up with BARDA on the work. And an antiviral from Japan's Toyama Chemical that's designed to target RNA viruses like the newly emerged SARS-CoV-2, favipiravir, showed early signs of efficacy in a 70-patient test.
U.S. lawmakers are taking an interest in the hunt for a treatment, writing to President Donald Trump that the HHS should not issue monopolies, Stat reports. That's because a monopoly could result in a high price and reduced access, the lawmakers wrote.
Officials in New Delhi may cut the duties on active pharmaceutical ingredients to boost supplies for Indian drugmakers. The country imported $2.5 billion worth of APIs from China last year, and alternative sources "are costly," an official told the New Indian Express. Duty cuts could keep the country's drugmakers competitive, the official said.
Case counts are mushrooming in South Korea, and the country reported its first COVID-2019 death. Two more passengers on the Diamond Princess died of the virus as disease control measures on the ship drew fire from a Japanese doctor. More than 600 cases emerged among the cruise's passengers. But the number of new cases dropped in China.
UPDATED: Wednensday, Feb. 19 at 10:39 a.m. E.T.
The Serum Institute of India has teamed up with Codagenix, a U.S. biotech, to start work on a vaccine, the Indian Express reports. Serum Institute used an algorithm to design several vaccine candidates and will test four in mice.
Analysts with Evercore ISI ran an investor sentiment survey and found that many investors don't believe the U.S. will experience a "self-sustaining" outbreak. Most will sell stocks if there are more than 1,000 cases in the U.S., the analysts wrote.
On the Diamond Princess cruise ship off of Japan, the number of people sick onboard has grown to 621, CNBC reports.
UPDATED: Tuesday, Feb. 18 at 9:15 a.m. ET
More than 80 clinical trials testing potential treatments and cures are in the works, and the World Health Organization is laying out clinical trial protocols to ensure the results actually mean something, Nature reports.
China's drug authority approved Zhejiang Hisun Pharmaceutial's favilavir to treat influenza. With some early efficacy stats showing activity against the novel coronavirus, the new med could garner off-label use. Company disclosure
The U.S. FDA is bracing for disruptions to the global supply chain for drugs and medical devices. The agency has reached out to hundreds of manufacturers, and so far, supplies are holding up. But the agency is ready should disruptions pop up. Story
Gilead's remdesivir, one promising treatment against the virus, has run into trial recruiting obstacles in China, the Wall Street Journal reports. Investigators hope to enroll 700 patients, but they have yet to identify even 200. One problem? To be eligible, patients must not have used any other treatments in the previous 30 days.
The outbreak may have caused "speculative buying" that's driving prices upward for certain pharmaceutical ingredients, Sun Pharma's managing director Dilip Shanghvi said on a recent conference call. "[T]here are many raw materials, which are dependent on China almost 100%," Shanghvi said, adding that the supply of ingredients for antibiotics such as penicillins and cephalosporins depend significantly on China. Azithromycin would have "maybe 80%, 90% dependence on China," he said.
Meanwhile, officials in India are considering export restrictions on several drugs to prevent local shortages, the Economic Times reports.
But Novartis CEO Vas Narasimhan told the same newspaper that the epidemic won't affect his company's drug supplies. The Swiss drugmaker is confident it can cover its production and distribution requirements for the “time being” from the existing stocks of raw material, he said.
Meanwhile, public health labs in several U.S. cities are testing people with flu-like symptoms, but who have tested negative for flu, for the coronavirus, the CDC says. Labs in Chicago, Los Angeles, New York City, San Francisco and Seattle are participating in the test.
And as the global case count climbs, a cruise ship outside of Japan still houses nearly 2,000 more people yet to be tested. The 454 cases found so far among that ship's passengers has surpassed the global case count outside of China. Perhaps more worrisome, a ship declared disease-free in Cambodia, the Westerdam, released its passengers to travel onward, but one of them has since fallen ill with the virus.
#DiamondPrincess What a disaster...— Andy Biotech (@AndyBiotech) February 17, 2020
Cumulative number of #COVID19 cases on ONE cruise ship just surpassed cumulative number of cases worldwide outside mainland China!
454 (26%) out of 1,723 samples tested positive, ~2000 more to be tested
h/t @jq1234t & @jodigraphics15 pic.twitter.com/RqOubhmAq7
UPDATED: Friday, Feb. 14 at 8:55 a.m. ET
One of the drug candidates with serious potential is Gilead's remdesivir, which has now shown it can reduce the severity of symptoms in monkeys infected with Middle East Respiratory Syndrome (MERS), an infection closely related to the novel coronavirus. Some reason for caution? Remdesivir also showed an effect on Ebola in monkeys that did not translate to humans.
China's state-owned medical products manufacturer is collecting plasma from recovered coronavirus patients as a basis for antibody treatment. China National Biotec Group Co. has used plasma to treat more than 10 seriously ill patients, the company said in a statement Thursday.
The outbreak has hit AstraZeneca's share price in the past few weeks, but CEO Pascal Soriot said on Friday the company has seen "limited disruption" due to the virus. Two Chinese AstraZeneca sites are running at nearly full speed after the drugmaker extended its Chinese New Year holiday period by an additional week due to the outbreak, he added. There has also been limited effect on ongoing trials, Soriot said.
The continued Chinese lockdown could also cause "breaks in supply chains" that could cause global drug shortages, EU health ministers warned on Thursday. So far, Europe hasn't seen any signs of shortages with Chinese manufacturers offline, but ministers said the bloc would institute a joint procurement plan to ensure medical supply shipments.
UPDATED: Thursday, Feb. 13 at 10:39 a.m. ET
Change in Hubei case reporting has made it next to impossible to track its coronavirus trend.— Simon Rabinovitch (@S_Rabinovitch) February 13, 2020
Here is what new confirmed cases would have looked like according to the old method (testing) vs new method (clinical diagnosis). On old basis it would have been another decline today. pic.twitter.com/4EIF4cCjC1
How might the crisis play out for pharma companies? Moody's published potential outcomes, and they're quite different for branded drugmakers and generics companies. If the outbreak persists, innovative drugmakers could see lower demand in China, but generics may see supply disruptions. Story
Gilead's remdesivir has shown early promise against the virus, and the company has responded by prioritizing development and building manufacturing capacity in the event the drug can effectively fight SARS-CoV-2, Wall Street Journal reports. It's working with contract producers and has also stopped production of an approved medicine at one of its own facilities to clear up capacity.
Vir Biotechnology, whose CEO is former Biogen chief George Scangos, has identified two monoclonal antibodies that bind to the virus, known as SARS-CoV-2. The company is further exploring whether the antibodies could fight the virus.
The U.S. needs more independence from pharmaceuticals from China and other countries, a top trade adviser for President Donald Trump told the Financial Times. The outbreak serves as a "wake-up call," he added.
UPDATED: Wednesday, Feb. 12 at 11:42 a.m. ET
The novel coronavirus outbreak continues to send shockwaves around the world, but the virus only now has a name: SARS-CoV-2. The sickness caused by the virus has been named COVID-19.
After setting up a "skunkworks" for its attack on the novel coronovirus, Johnson & Johnson is teaming with the U.S. Biomedical Advanced Research and Development Authority to develop a vaccine. J&J is pooling money and resources with BARDA in an attempt to accelerate its vaccine candidate into phase 1 development. The company's also gearing up manufacturing facilities for potential production.
By contrast, NIH and Moderna Therapeutics quickly kicked off their R&D program, but they don't have a manufacturer yet. Neither partner has the capacity to produce the shot if it's successful in clinical testing, an official said. But pharma companies might not want to sign up because they'd have to stop producing their own profit-making vaccines. Story
After Gilead's remdesivir emerged as a promising treatment for the virus, a Chinese company has successfully copied the medicine and mass-produced active ingredients, it said in a filing. The company stressed that final marketing will require permission from Gilead. Story
WuXi Biologics is getting back to work. The company resumed operations at its sites in Wuxi, Shanghai and Suzhou Tuesday after the Chinese New Year holiday. Only 6% of its staff traveled to or through Wuhan, or came in contact with people who were in Wuhan, the company said. It's continuing to monitor employee health and says enough employees are back to their hometowns to get operations underway.
Another vaccine player has jumped into the fray. German biotech CureVac AG and the Coalition for Epidemic Preparedness Innovations have expanded an existing partnership to research a potential coronavirus vaccine. The agreement adds $8.3 million in funding to their prior deal for accelerated vaccine development, manufacturing and clinical trials.
UPDATED: Tuesday, Feb. 11 at 10:36 a.m. ET
While the World Health Organization is seriously concerned about the situation in China, the outbreak still "holds a very grave threat for the rest of the world," Director-General Tedros Adhanom Ghebreyesus said in Geneva, as quoted by CBS News. Transmission in other countries could be a "spark" that would light a larger fire, he said. The agency has tracked 393 cases outside of China.
Meanwhile, the agency has sent a team to China to help investigate the outbreak, Reuters reports. The group, which could "range between 10 and 15" people, will be led by Canadian expert Dr. Bruce Aylward, the WHO chief said.
Zhong Nanshan, China's top adviser on the outbreak, told Reuters he hopes the crisis will be over in April. New case numbers are falling, he said, and he believes the outbreak will peak this month.
UPDATED: Monday, Feb. 10 at 11:42 a.m. ET
As drugmakers scramble together R&D projects, AI-focused firms have used that technology to formulate ideas about which molecules might work to fight the virus, Fast Company reports. Benevolent AI says Lilly’s rheumatoid arthritis med Olumiant carries promise, for instand. And Insilico Medicine, another AI-focused drug discovery company, identified 6 other molecules.
After the World Health Organization on Friday warned of drug shortages due to the outbreak, new FDA commissioner Stephen Hahn said there haven’t been any reported shortages in the U.S., Politico reports. Still, the situation is “fluid,” he noted. The agency has pulled its inspectors out of China.
Meanwhile, India is taking stock of critical drug supplies, the Indian Express reports. China is a major supplier to that country, and on-hand supplies will last two more months, multiple companies told the publication.
Aiming to help with the R&D effort against the virus, two U.K. research agencies have started a £20 million fund, PharmaTimes reports. They’re asking scientists to submit ideas for combatting the virus and awarding money for promising projects. In the U.K., the case count has doubled to 8 and officials have declared an “imminent threat,” Reuters reports.
French biotech Novacyt has applied for emergency approval from the FDA for its coronavirus diagnostic, sending shares up. The company’s share price has tripled so far in 2020.
Meanwhile, the outbreak has kept gaining steam, but some Chinese cities are getting back to work on Monday, the South China Morning Post reports. Companies in Beijing, Shanghai and Shenzhen have been allowed to reopen following an extended holiday for the Chinese New Year. Still, the government asked companies to continue to be flexible, for instance allowing employees to work from home when possible.
UPDATED: Friday, Feb. 7 at 10:57 a.m. ET
The first patient has been dosed in a China clinical trial testing Gilead drug remdesivir’s use against the novel coronavirus. According to investigators, the phase 3 study is divided into two parts—one among mild-to-moderate pneumonia patients and the other in serious cases—and aims to enroll a total of 761 subjects. Patients will be followed for 28 days and readouts are expected as early as April.
Fearing the coronavirus could affect drug supplies from China, U.S. Sens. Marco Rubio and Chris Murphy on Thursday called on FDA Commissioner Stephen Hahn to ensure the quality of the drugs from the country. “[W]e are concerned that the pandemic could impact the FDA’s ability to monitor compliance with good manufacturing standards and the ability for Chinese manufacturers to maintain supplies to meet demand in the United States and the growing demands in China,” they write in a letter (PDF).
After speaking by phone with China’s President Xi Jinping, President Donald Trump turned to Twitter to praise China of its “great discipline.” He said: “We are working closely with China to help.”
....he will be successful, especially as the weather starts to warm & the virus hopefully becomes weaker, and then gone. Great discipline is taking place in China, as President Xi strongly leads what will be a very successful operation. We are working closely with China to help!— Donald J. Trump (@realDonaldTrump) February 7, 2020
South China Agricultural University scientists said that the genome sequence of the novel coronavirus separated from pangolins, a scaly anteater, was 99% identical to that from people. They suggest the animal is “the most likely intermediate host.” But other scientists have doubts of the claim, Reuters reported.
UPDATED: Thursday, Feb. 6 at 11:20 a.m. ET
Gilead's remdesivir has been identified as one of the most promising treatments against the coronavirus. But a recent move by a Chinese research institute to try to patent the drug's specific use in 2019-nCoV has drawn controversy. Commenting on the case at an internal company event, Gilead CEO Daniel O'day said the company's responsibility is to carry out the right clinical programs to determine remdesivir's efficacy against the virus and to ramp up production if it does so that it can reach as many patients as possible. The "patent is not at the forefront of our mind," he said. While Gilead has patents on the drug for all of its uses, including coronavirus, the company "will not get into a patent dispute," he added.
Amid a flurry of commitment from different drugmakers to fight the coronavirus, Sanofi CEO Paul Hudson said the French pharma will unveil a coronavirus initiative of its own within the next two weeks. “We are one of the few companies that has the expertise to know when it is just a fantasy, or when it could be real. In the next week or two, you will see something more confirmatory about the approach we will take,” Hudson said at a news conference on Thursday, as quoted by Reuters.
Li Wenliang, the Chinese doctor who tried to sound an early alarm about the novel coronaivurs but was silenced by local authorities, has passed away.
Bristol-Myers Squibb has limited and restricted employee travel to and from China. At the same time, the New York company said it's "diligently monitoring manufacturing and supply facilities across the globe," and that it doesn't expect any disruptions to the supply of its medicines.
Novo Nordisk has extended the Chinese New Year holiday for its employees in China, following a recent recommendation by the Chinese government. That means Novo doesn’t have sales reps pushing innovative drugs in the field, which could lead to slower growth in the short term, CEO Lars Fruergaard Jørgensen said in an interview.
In other parts of the world, the U.K. has recorded its third coronavirus case. And the number of passengers on a Princess cruise ship in Japan who have tested positive for the coronavirus has grown to 20.
UPDATED: Wednesday, Feb. 5 at 10:02 ET
Looking to stop the spread of coronavirus in the U.S. before it starts, the FDA has granted an emergency authorization to the Centers for Disease Control and Prevention’s (CDC's) novel coronavirus diagnostic, allowing it to be used at qualified and designated laboratories across the country. Until now, the test could only be used to evaluate samples shipped to the CDC’s own labs, slowing the agency’s turnaround time in responding to the spread of the disease.
How does Regeneron plan to tackle the coronavirus? With the antibody expertise that has served it so well in developing meds such as the blockbuster immunology therapy Dupixent. Not to mention its previous antiviral work, against Ebola and MERS, the new 2019-nCoV's fellow coronavirus.
In the search for a coronavirus treatment, a Chinese research facility is taking the unusual step of attempting to patent one of Gilead Sciences' experimental antiviral candidates, remdesivir, that has shown clinical promise. One problem with that approach? Gilead owns the underlying patent and likely isn't interested in sharing it.
Speaking of remdesivir, the World Health Organization has designated Gilead's drug as the most promising candidate as a treatment for coronavirus given its strong clinical efficacy. The WHO is also putting a "master protocol" in place to test multiple investigational therapies at once in a move to expedite development.
With some of the major drugmakers stepping in to help develop a new coronavirus treatment, GlaxoSmithKline plans to leverage its pandemic vaccine adjuvant platform to help the cause.
UPDATED: Tuesday, Feb. 4 at 10:23 a.m. ET
Each day, more companies are jumping into the fray. On Tuesday, Regeneron unveiled an expanded partnership with the U.S. Department of Health and Human Services aimed at developing antibodies to fight the new coronavirus.
Swiss contract developer and manufacturer Lonza opted to keep four plants in China closed after its Chinese New Year holiday to help arrest the virus' spread. It's also imposing travel restrictions for employees and any who've traveled to China will face a two-week quarantine when they return. Story
Experts aren't sure when the outbreak will peak, Evercore ISI analyst Josh Schimmer wrote in a note following an expert webinar. From this point, possible outcomes include "containment," or a "massive global pandemic" he wrote in a note to clients. He tallied up 10 pharma companies in the hunt for drugs and vaccines to fight the virus.
Australia's CSL is exploring the ways it can help, the Sydney Morning Herald reports. The virus doesn't fall within CSL's core focus areas, the company said, but it's still looking at ways it can lend its expertise.
Meanwhile, Hong Kong has recorded its first death and the global case count climbed to more than 20,000, the Wall Street Journal reports.
UPDATED: Monday, Feb. 3 at 9:37 a.m. ET
Another player is jumping into the global vaccine hunt. GlaxoSmithKline and the Coalition for Epidemic Preparedness Innovations unveiled a new partnership that aims to make GSK's adjuvant technology available to others working on early-stage vaccines. So far, the University of Queensland in Australia has an agreement to use the adjuvant. Story
Aside from vaccine efforts, Gilead is among those working on a potential therapeutic. The company is exploring whether its failed Ebola drug remdesivir could work to treat the infection after the medicine seemed to help the first patient in the U.S. with their infection. The drug is set for further testing in China. Story
As the outbreak intensifies, questions about the global drug supply chain have swirled. If China shuts down its borders or is shunned from international trade, will there be enough supply of pharmaceuticals? Drugmakers say they are prepared. Story
U.S. regulators certainly aren't taking the threat lightly. New FDA commissioner Stephen Hahn told Politico that while there haven't yet been reports of supply chain interruptions, he's preparing for “what could potentially be the most serious of scenarios.” The HHS has declared the outbreak a public health emergency Friday, so the FDA's role in the emergency will be heightened going forward. Politico story
UPDATED: Friday, Jan. 31 at 8:43 a.m. ET
As of Friday, at least a dozen vaccines and several treatments are in development, BioCentury reports. Almost as soon as the publication published a chart detailing the ongoing work, though, the landscape had changed. Aside from the dozen vaccines listed there, Vaxart unveiled its own program Friday morning.
Meanwhile, Roche says it has developed the first commercial test for the outbreak, Bloomberg reports. The new diagnostic can detect the virus in a few hours, according to the company.
The Institut Pasteur said it had sequenced the entire genome of the virus, formally known as 2019-nCoV, and its scientists have made virus samples available for research. The institute's announcement follows The Lancet's publication Thursday of its own sequencing work.
Instead of wearing face masks, the CDC recommends Americans remain "vigilant" about symptoms of the virus, which include fever and cough, and follow typical techniques for combatting the spread of flu, such as washing hands regularly and using hand sanitizer. Still, mask suppliers tell us supplies are running short, and anecdotal reports say at least some retail outlets are out of stock.
In Singapore, it's a different story as members of the Singapore Armed Forces are packing millions of masks for distribution to the public.
Scientists at the Chinese Academy of Sciences' Wuhan Institute of Virology and military researchers found that remdesivir, chloroquine and Norvir (ritonavir) exhibit good inhibitory effects on 2019-nCoV at the cellular level. They are now under relevant procedures to gain official approval for clinical use.
UPDATED: Thursday, Jan. 30 at 2:41 p.m. ET
Johnson & Johnson on Wednesday unveiled its “multi-pronged” response that includes a vaccine R&D effort in a "skunkworks" in the Netherlands, according to Chief Scientific Officer Paul Stoffels. It's also testing whether existing medicines could tackle the novel virus and donating antiviral drugs to Chinese hospitals.
Meanwhile, AbbVie's HIV drug Kaletra was plucked out by Chinese authorities for use against the pneumonia triggered by the novel virus. AbbVie in turn announced a $1.5 million donation of the drug.
Moderna Therapeutics and Inovio are scrambling to develop vaccines of their own, and local outbreak preparedness group CEPI has pledged funding for their early-stage efforts. The group formed in response to prior outbreaks and has doled out hundreds of millions of dollars for outbreak prep efforts. Inovio and Moderna are only two of the early vaccine efforts that have been announced; Moderna believes its mRNA vaccine technology could "serve as a rapid and flexible platform" to respond to emerging pathogens, including the new coronavirus.
From afar, it can sound like the whole of China has been overtaken by the outbreak of the novel and deadly coronavirus, but Chinese CDMO WuXi Biologics offered some reassurance: It'll continue to supply the critical drugs it produces for markets around the world. The contractor said its workforce and operations are unaffected, and it's “working vigilantly to execute our Business Continuity Plan to mitigate any potential risk” and ensure its products are unaffected by the outbreak.
For its part, Roche is running into logistical trouble, thanks to the numerous Chinese cities in lockdown mode. The travel barriers have proven a complication for delivering diagnostic kits, the company said. Meanwhile, China just approved several new diagnostic kits from Sansure Biotech to help detect cases.
To keep its own workforce safe, Sanofi has asked employees to stop travel to and from Wuhan and the Hubei province, Reuters reports, as the case count climbs.
The outbreak continues to spread beyond China, too. As of Thursday, the World Health Organization reported 82 other cases have been confirmed in 18 countries. J&J says cases have been logged in Australia, Cambodia, Canada, France, Germany, Hong Kong, Japan, the U.S. and elsewhere.
The U.S. and Japan have evacuated hundreds of people from China, and other countries are planning similar evacuation flights, AP reports. Americans on the U.S. evacuation flight are undergoing testing at a military base in California.
And about 6,000 people are stuck on a cruise ship off of the coast of Italy as authorities suspect two cases on board.