Coronavirus tracker: Sinovac unveils midstage vaccine data; Daewoong OK'd to test tapeworm med against virus

China's Sinovac kicked off a coronavirus vaccine trial in Indonesia and revealed promising data on its candidate from a mid-stage study. 

South Korea's Daewoong Pharmaceutical got a thumbs up to test a tapeworm drug against COVID-19 in India. Meanwhile, researchers at a U.S. university will test whether the antidepressant Luvox could curb cytokine storm in coronavirus patients. 

Plus, Switzerland called dibs on 200,000 doses of an experimental COVID-19 treatment from Molecular Partners, and the Serum Institute of India thinks it could have a shot ready to go by year-end, CEO Adar Poonawalla said.

The worldwide case count had climbed past 20.1 million Tuesday morning, with more than 737,000 reported deaths, according to Johns Hopkins University's COVID-19 dashboard.

Please read below for updates. We'll chronicle the latest here. Daily COVID-19 tracker entries from Jan. 30 through April 20 can be found here.

UPDATED: Tuesday, August 11 at 9:30 a.m. ET

China's Sinovac launched a late-stage COVID-19 vaccine trial in Indonesia Tuesday with local drugmaker Bio Farma, aiming to enroll about 1,620 subjects to test its candidate, CoronaVac. A day earlier, Sinovac turned out positive data from a 600-patient phase 2 study conducted in China, showing the shot was safe and triggered a neutralizing antibody response.

South Korea-based Daewoong got the OK to run an early-stage trial of its anti-parasitic drug niclosamide in coronvirus patients in India. Run in partnership with India's Mankind Pharma, the phase 1 will enroll about 30 participants and kick off later this month. If the phase 1 goes well, Mankind will take charge of mid- and late-stage testing in mild and severe coronavirus patients. The tapeworm med completely neutralized the virus in animals' lungs during preclinical tests, Daewoong said. 

The antidepressant Luvox (fluvoxamine) could thwart dangerous overreactions of the immune system in COVID-19 patients, researchers at Washington University School of Medicine in St. Louis figure. The team plans a clinical trial to test whether the common SSRI can prevent "cytokine storm," a potentially fatal reaction to the virus, in 152 patients with confirmed COVID-19 cases. 

Zurich, Switzerland-based Molecular Partners is advancing an experimental drug to fight COVID-19, and the Swiss government has anted up a payment in the "high single digit millions" of Swiss francs to lock down 200,000 initial doses, the company said. The Swiss government has the option to order another 3 million doses of the drug, which Molecular Partners aims to push into the clinic later this year. 

The Serum Institute of India should have an approved COVID-19 shot by the end of the year, with the final price tag set for reveal in about two months, CEO Adar Poonawalla said. On Friday, the Serum Institute, the world's largest shot maker by volume, allied with Gavi, the Vaccine Alliance and the Gates Foundation to crank out 100 million doses at $3 per shot for India and lower-income countries. Meanwhile, the Serum Institute is gearing up to run Indian trials on AstraZeneca and the University of Oxford's candidate later this month. 

UPDATED: Monday, August 10 at 3:25 p.m. ET

Moderna says it's on track to recruit a full 30,000 subjects for its vaccine trial by September, but slow enrollment so far has vaccine experts doubting the shot's chances at a green light before U.S. elections in November. As of Friday, only 54 of the trial's 89 sites were online, Moderna said; even if recruitment picks up, as NIAD director Anthony Fauci and NIH chief Francis Collins expect, the trial design means results won't come until the first quarter of 2021 at the earliest, vaccinologists Peter Hotez and Paul Offit figure. 

Inovio's stock has soared on positive news about its DNA-based COVID-19 vaccine, but the biotech has never before brought a vaccine to market, nor has a DNA-based shot ever been approved. And those aren't the only two reasons why investment analysts and medical experts are giving Inovio's vaccine the side-eye. They also cite misleading claims about its Warp Speed backing, plus a spree of insider share sales and sparse phase 1 data. 

Russia's plan to inoculate the public with a yet-to-be-approved COVID-19 vaccine from Moscow's Gamaleya institute—possibly starting this week—drew ire from the multinational Association of Clinical Trials Organizations (ACTO), which equated the move to opening Pandora's Box. "[W]e don’t know what will happen to people injected with an unproven vaccine," ACTO executive director Svetlana Zavidova said. As of early August, less than 100 people had officially received the vaccine, ACTO said. 

Drugmakers toiling away at COVID-19 vaccines and treatments won favor with the public, early August data from the Harris Poll show. Pfizer, boasting a recent vaccine supply pact with the U.S., led the pack with a 52% increase in positive opinion from respondents aware of the deal. Among those in the know about Moderna's phase 3 launch, 51% reported an improved opinion of the company, and 42% of those polled about Gilead said they'd warmed to the remdesivir-maker. Story

COVID-19 may not have spared contract research organization PPD completely in the second quarter, but the CRO managed to dial up revenue by 1.4% to $1.01 billion, thanks to its testing and vaccine trial efforts. While the coronavirus slowdown sunk revenues from clinical development services by 2.2%, COVID-19 testing saw the company's laboratory services sales rocket 19.9% to $195.7 million. Plus, PPD is currently in league with Moderna and the NIH on their late-stage mRNA vaccine trial. Story

Kodak's $765 million drug manufacturing loan from the U.S. government turned heads from the get-go. Now, the U.S. International Development Finance Corporation has put that cash on hold, citing "allegations of wrongdoing." Last week, a group of House Democrats challenged Kodak's pharmaceutical qualifications, requesting documentation about the loan days after the Securities and Exchange Commission launched a probe into the deal over suspicious trading and stock maneuvering ahead of the announcement. Story 

San Francisco startup GigaGen used plasma from 50 subjects with known infections or COVID-19 symptoms to source hundreds of thousands of virus-fighting antibodies. Then, it whittled those prospects down to 12,500 of the most potent antibodies, and combined them into a candidate now dubbed GIGA-2050. After lab studies found the candidate 100 times more potent than convalescent plasma, GigaGen expects to launch human trials next year. Story

UPDATED: Monday, August 10 at 9:22 a.m. ET

Gilead submitted Veklury, better known as remdesivir, for an official FDA approval. The drug started its COVID-19 regulatory journey with a rolling new drug application in early April. It landed an FDA emergency use authorization in May, shortly followed by its global-first nod in Japan, as well as a conditional EU go-ahead last month. The filing is based on data from phase 3 clinical studies: One by the National Institute of Allergy and Infectious Diseases showed the med could cut recovery time by 31%, and the other found that a 5-day or 10-day treatment duration led to a similar clinical improvement.

Brazil will set aside 1.9 billion reais ($356 million) to buy and eventually produce AstraZeneca and the University of Oxford's COVID-19 vaccine candidate. Through the expansion to an earlier deal for 30 million finished shot doses, the country hopes to receive its first 100 million vaccines around January, Brazil's health minister said. Those shots would cover roughly half the country's population, after which Brazil would begin turning out its own vaccine supplies via the AZ partnership with the Oswaldo Cruz Foundation inked in June. 

Doctors and government staffers in Moscow received an offer for early COVID-19 inoculation with the Gamaleya Research Institute's vaccine hopeful, and at least one hospital is already signing up employees, according to a doctor who received the pitch. The shot is expected to score a conditional OK from Russian health authorities this month. Production could kick off by September, Deputy Prime Minister Tatyana Golikova said. 

Meanwhile, as November's election looms, medical experts worry that FDA chief Stephen Hahn may not be able to withstand the political pressure of the U.S. pandemic response. Some common critiques? Hahn (and his agency's) emergency authorization for the now-discredited COVID-19 treatment hyrdroxychloroquine, touted by President Donald Trump, and the FDA's slow switch to state and commercial labs for coronavirus testing. Now, experts fear Hahn's oversight may not hold up against political meddling in the rush to get a vaccine approved by November. 

And as COVID-19 dominates the focus—and funding—of pharmas across the U.S., drugmakers have still found time and money to donate to more than two-thirds of the sitting members of Congress, Stat reported. So how does the industry's political spending break down? Pharmas and their trade groups contributed roughly $11 million to campaigns this year, favoring Republican legislators and lawmakers viewed as industry allies. Pfizer has cut the most checks of any drugmaker, but other COVID-19 players such as AstraZeneca and Gilead Sciences have also anted up. 

Meanwhile, Microsoft co-founder Bill Gates slammed the U.S.' coronavirus "testing insanity," bashing long lines, delayed results and unequal access to quicker-but-costlier tests. Another concern? The federal government's inaction, even as public officials cite testing delays as a major hurdle to the nation's pandemic response. 

Plus, "vaccine nationalism," wherein wealthy nations lock down vaccine supplies ahead of other countries, could hamstring the global fight against COVID-19, health and economic experts warned. To curb global infection rates, people at the highest risk, including healthcare workers, need to get vaccinated first, regardless of where they live. Meanwhile, countries placing bets on a single candidate could face a nasty surprise if those shots sputter in the clinic, and price bidding between wealthy nations could jack up shot prices worldwide, experts said. 

UPDATED: Friday, August 7 at 3:22 p.m. ET

Moderna's late-stage vaccine trial attracted 1,290 participants over its first five days, but the enrollment pace for the 30,000-person trial should pick up as the study continues, NIAID director Anthony Fauci told CNN. While testing results could come as early as October, Fauci thinks a November or December readout looks more likely. Last week, Fauci said he had hoped for higher enrollment numbers at the trial's start, but has since called the statement "tongue-in-cheek."

The Bill & Melinda Gates Foundation teamed up with the Serum Institute of India to crank out 100 million coronavirus vaccines for low- and middle-income nations at $3 a pop. Gavi, The Vaccine Alliance will also back efforts by the Serum Institute—the world's biggest vaccine maker by volume—to help organize and finance the inoculation goal. Meanwhile, the Serum Institute has signed on to produce 1 billion doses of Oxford and AstraZeneca's COVID hopeful. 

The National Institutes of Health launched a new research program to better diagnose a severe COVID-19 complication in children, with plans to dispense $20 million in grants over the next four years. The PreVAIL kIds initiative aims to boost development of new tests for the genetic, immune, viral and environmental factors that can cause COVID-19 to progress to Multisystem Inflammatory Syndrome in Children, a rare but potentially lethal reaction that attacks several organs at once. Story 

A variant of the body's naturally occurring ACE2 receptors could treat COVID-19 by luring the virus away from healthy cells, according to researchers at the University of Illinois, Urbana-Champaign. The team's three-way ACE2 combo bound to the virus at levels on par with COVID-fighting antibodies and effectively neutralized it, too, a study published in Science showed. Another boon? To escape the team's ACE2 treatment, the virus would need to mutate in a way that makes it less infectious, the researchers said. Story

With election season looming, the FDA has vowed to avoid political pressure in the quest to rapidly approve a COVID-19 vaccine. Earlier this week, President Donald Trump said a vaccine green light by November "wouldn't hurt" his chances at reelection; meanwhile, Fauci maintained that White House interests aside, he has yet to see "any indication of pressure at this point to do anything different than what we're doing." Story

Only three U.S. states—Maine, New Hampshire and Vermont—have enough contact tracers to meet their coronavirus investigation needs, NPR reported, citing the Contact Tracing Workforce Estimator. In June, the CDC told Congress that the U.S. would need 100,000 contact tracers to combat COVID-19. That workforce stood 41,122-strong by July's end, a survey by NPR and the Johns Hopkins Center for Health Security found.

UPDATED: Friday, August 7 at 9:13 a.m. ET

With reports of remdesivir scarcity rolling in from U.S. hospitals, Pfizer has stepped up to provide contract manufacturing for Gilead Sciences. Pfizer said the multiyear pact, centered on its plant in at McPherson, Kansas, aligns with its stated goal to spur collaboration in the fight against COVID-19. Pfizer is one of several external manufacturers aiding in the remdesivir scale-up, the company said. Story

For its part, Gilead says it has shortened manufacturing time on remdesivir to six months and enlisted more than 40 companies in the U.S., Europe and Asia to help shore up supplies of the antiviral. Gilead says it now expects to meet real-time demand starting in October, and it aims to deliver more than 200 million treatment courses by 2020's close.

Novavax tapped Takeda Pharmaceutical to develop, produce and sell its vaccine in Japan. The Tokyo-based drugmaker signed up to crank out more than 250 million doses of Novavax's recombinant protein shot per year, plus head up development and marketing in the country. Novavax will supply its Matrix-M adjuvant. And Japan's Ministry of Health will offer up funding for technology transfer and manufacturing scaleup. Story

Meanwhile, Novavax enlisted the Serum Institute of India to make and sell its vaccine hopeful in low- and middle-income countries, including India. Novavax will initially provide the vaccine antigen and adjuvant, but the two are in talks to have Serum Institute churn out antigen on its home turf. The deal builds on Novavax's prior pact with the Coalition for Epidemic Preparedness Innovations to fairly deploy vaccines around the globe.

Japan called dibs on 120 million doses of AstraZeneca's Oxford-partnered vaccine, the country's health minister said Friday, and a cadre of Japanese drugmakers will help. AstraZeneca will produce vaccine substance in-country with Japan's JCR Pharmaceuticals, importing other ingredients from overseas. Locally based drugmakers Daiichi Sankyo, Meiji Seika Pharma and KM Biologics will help build out the Japanese supply, too. Story

Enrollment in Pfizer's late-stage mRNA vaccine trial is set to wrap by the end of August, with results expected in October, CEO Albert Bourla told the Washinton Post. The Big Pharma and partner BioNTech started enrolling in July, aiming to recruit a total of 30,000 subjects. 

A team from the University of Minessota is pitting natural killer (NK) cells—designed to fight cancers like lymphoma—against COVID-19. The team snagged FDA approval to run tests on the immune cells in patients with moderate illness, starting with low doses to determine whether they spur an overreaction in patients' immune systems.

UPDATED: Thursday, August 6 at 2:30 p.m. ET

The NIH launched a phase 3 trial of Gilead Sciences' antiviral remdesivir and Merck KGaA's interferon-based multiple sclerosis drug Rebif. The ACTT 3 trial aims to enroll more than 1,000 adults hospitalized with COVID-19 and test a combination of the two drugs against remdesivir alone. The idea is that Rebif—which dampens MS flares by modulating the immune system—may work alongside remdesivir to help patients recover more quickly. 

Speaking of Merck KGaA, CFO Marcus Kuhbert ballparked a vaccine timeline for Bloomberg TV, saying it will be at least 9-12 months, and as many as 15, "before we might have a vaccine that also works." The German drugmaker's manufacturing services business is working with some 200 coronavirus players—including Oxford's AstraZeneca-partnered Jenner Institute—helping develop processes and scale-up plans for vaccines and therapeutics.

Meanwhile, the NIH is turning to artificial intelligence and imaging scans to not only detect COVID-19 cases earlier, but potentially to personalize treatments for individual patients. A collaboration funded by the agency—led by a radiology researcher at the University of Chicago—aims to develop diagnostics and machine-learning algorithms to quickly assess the severity of an infection and predict response to various treatments. Story

Anyone worried the pandemic might stall funding in the cell and gene therapy field was wrong—in fact, just the opposite. During the first half of 2020, the regenerative medicine sector raised $10.7 billion, more than twice as much as in the same period of 2019. Meanwhile, some companies in the space have joined the hunt for COVID treatments, leaning mostly on potential cell therapies for the acute respiratory distress syndrome (ARDS) associated with severe cases. Story

Researchers in South Korea showed that even people without symptoms carry as much coronavirus in the nose, throat and lungs as symptomatic patients, The New York Times reports. Though medical experts thought as much, it's the first study to confirm the fact. "[I]t does confirm what we’ve suspected for a long time — that asymptomatic cases can transmit infection," an epidemiologist not involved in the study told the newspaper.

UPDATED: Thursday, August 6 at 9:15 a.m. ET

AstraZeneca rounded out its vaccine strategy by shoring up supplies in one of its key markets, China. The British drugmaker tapped BioKangtai to reserve capacity for at least 100 million Chinese doses by 2020's close and expand to 200 million doses per year by the end of 2021. BioKangtai may also produce doses for other markets, AstraZeneca said. Financial terms are still under wraps. Story 

Last month, HHS secretary Alex Azar said the U.S. would be swimming in hundreds of millions of COVID-19 vaccine doses by early next year. NIAID director Anthony Fauci walked back that estimate Wednesday, but it wasn't all bad news; drugmakers will likely have tens of millions of shots available in the first half of 2021, Fauci told Reuters, adding that there could be a billion vaccine doses available by the end of the second half. 

The FDA eased its rules on "in-use time" for 10 drugs used to treat seriously ill COVID-19 patients, including antacids, epinephrine, muscle relaxers and more. The new guidance aims to ensure hospitals have enough of those drugs, many of which are in short supply, to treat their coronavirus patients.

Responding to global drug shortages of IV sedatives used in ventilated COVID-19 patients, a team from Canada's Lawson Health Research Institute nabbed funding to study whether inhaled sedatives could replace injections in coronavirus patients. The researchers aim to recruit around 800 subjects in Canada and the U.S. for a test of the inhaled versions, in hopes of easing the burden on critical drug supplies. Early research has shown inhaled sedatives may reduce time on ventilators and potentially slash death rates, too.

Nursing home residents likely account for 40% of COVID-19-related deaths, Karin Huster of the healthcare non-profit Médecins Sans Frontières (MSF) told Bloomberg. While the facilities have implemented infection safeguards, their elderly residents remain at high risk. To help curb the spread, MSF has stepped in to teach clinical and non-clinical nursing home staff how to integrate coronavirus safety protocols into their day-to-day routines. 

New York has already locked down airports and tapped Port Authority police to screen passengers entering the state from COVID-19 hotspots. Now, New York City will set up checkpoints along bridges and tunnels into the five boroughs in an effort to curb outbreaks triggered by visitors arriving by car. Four dozen states are on New York's mandatory quarantine list, including Rhode Island, Maryland and Virginia. 

UPDATED: Wednesday, August 5 at 3:34 p.m. ET

Moderna's experimental vaccine protected mice who were exposed to the novel coronavirus, the National Institutes of Health reports. The vaccine is already in phase 3 testing, and the drugmaker today said it'll charge $32 to $37 per dose for small orders.

As leading COVID-19 vaccine players advance their programs, pricing is becoming clearer, the Wall Street Journal reports. AstraZeneca has a deal with the U.S. for $4 per dose, while J&J's Wednesday agreement is for $10 per dose. Pfizer's U.S. agreement is for $19.50 per dose, while Moderna said it'd charge a much higher price.

Health officials in more than a dozen states have been subjected to personal attacks and harassed amid the pandemic, authors wrote in the Journal of the American Medical Association. They said the harassment "must stop" and that "all efforts and attacks should be directed against the virus."

After Sen. Elizabeth Warren asked the Securities and Exchange Commission to probe trades in Kodak shares, Democrats have started their own investigation, the Wall Street Journal reports. The company last week scored a $765 million loan to produce active pharmaceutical ingredients. 

UPDATED: Wednesday, August 5 at 9:30 a.m. ET

Johnson & Johnson pledged to deliver up to 300 million doses of its shot to the U.S., with 100 million upfront and an option for 200 million more. The deal, worth more than $1 billion, will be funded by the HHS' Biomedical Advanced Research and Development Authority (BARDA) and the Defense Department. And J&J will turn out those doses in the U.S., thanks to government support for its R&D and manufacturing scale-up.

Novavax unveiled early data on its vaccine prospect, NVX-CoV2373, and so far, so good. The phase 1 data from a phase 1/2 trial showed two regimens featuring an adjuvanted version of the shot delivered a solid number of neutralizing antibodies. The lower dose—5 micrograms—yielded similar levels to the higher, 25 microgram dose. No serious safety issues cropped up, though a false media report of participant hospitalizations did send the company's shares into a tailspin in after-hours trading Tuesday afternoon. Story

Canada called dibs on vaccine doses from Pfizer and BioNTech, provided their candidate proves itself in clinical trials. Under their supply deal, the vaccine partners will supply doses of their mRNA-based shot, now known as BN162, beginning in 2021. The financial terms of the deal weren't released—and nor was information about the number of doses involved—but the announcement emphasized that the Pfizer-BioNTech team is on track to deliver 1.3 billion doses worldwide by the end of next year.

BioNTech and another vaccine partner, Fosun Pharma, launched their promised phase 1 trial in China. The first 72 recipients have already been dosed with BioNTech's BN162b1—one of the German company's two leading candidates—with 72 more to come. The first stage of the test focuses on healthy adults up to 55 years old, while the second phase will enroll the elderly.

Zydus Cadila wrapped up a phase 1 test of its vaccine, ZyCoV-D, and now it plans to move the candidate directly into a 1,000-subject phase 2. It's been a speedy trip so far for the DNA-based shot, which won approval for clinical trials in early July and moved into the adaptive phase 1/2 less than two weeks later. Info on the performance is limited, though; the company only said the vaccine was well tolerated. Story

India's Sun Pharmaceutical challenged its domestic rival Glenmark with a less costly version of the antiviral favipiravir, a flu-fighter better known as Avigan. Dubbed FluGuard—despite its approval to treat mild to moderate COVID-19—Sun's version is priced at 35 rupees per tablet, compared with Glenmark's FabiFlu at 75 rupees.

It's no surprise that the pandemic sussed out weaknesses in the global drug supply chain. But FDA Commissioner Stephen Hahn says U.S. drugmakers could help ensure the flow of APIs and finished meds by moving their manufacturing into the 21st century—and in a blog post, he outlines some agency programs that could help.

UPDATED: Tuesday, August 4 at 4:00 p.m. ET

The NIH plans a series of trials testing monoclonal antibodies against COVID-19, beginning with two phase 2/3 studies. An Eli Lilly antibody, LY-CoV555, will be the first in line, and it'll start by entering a 220-patient trial in unhospitalized patients to see if it can prevent hospitalization or death. If proven safe, the antibody will move into a 2,000-patient phase 3—and meanwhile, other antibodies could join the mix. The second set of studies will test the Lilly antibody—along with other prospects—in patients already in the hospital.

Four former FDA commissioners—Mark McClellan, Margaret Hamburg, Robert Califf and Scott Gottlieb—want the U.S. to put convalescent plasma through clinical trials. Officials should urge recovered COVID patients to donate their plasma, not just for use in treating patients, but for randomized clinical testing to determine how well such treatment works, the ex-FDA chiefs wrote in a Washington Post op-ed.

A bipartisan coalition of 30 state AGs demanded that U.S. health agencies crack open the market for Gilead Sciences' remdesivir, the only antiviral proven to work against Sars-CoV-2. The government should exercise its "march-in rights" under the Bayh-Dole Act to allow generic versions of the Gilead drug, which is priced at $250 per vial, the letter argued.

Honeywell had planned to launch a new line of tough drug vials and bottles in June, but the pandemic delayed that rollout—while offering a new opportunity. Hearing that glass vials could run scarce in the race to distribute hundreds of millions of vaccine doses, the company added a new, smaller vial to its Aclar Edge line.

UPDATED: Tuesday, August 4 at 9:00 a.m. ET

Regeneron's antibody cocktail, which recently moved into phase 2/3 human testing, has proven effective at treating and preventing COVID-19 disease in rhesus macaques and hamsters. The two-drug combo, known as REGN-COV2, showed it could "almost completely block establishment of virus infection," the company said, as quoted by Reuters. The study hasn't been peer-reviewed yet, and the positive results don't guarantee the cocktail will succeed in humans.

In Gilead Sciences' portfolio is a drug, GS-441524, that some cat owners buy on the black market to treat feline infectious peritonitis, or FIP. It's also related to the coronavirus drug remdesivir—and its patent expires first. In a letter to the company and four U.S. agencies, Public Citizen urged Gilead to study GS-441524 in humans for COVID-19, saying the treatment, if effective, could be a lower-cost alternative to remdesivir. And it might actually be easier to convert to inhaled or oral form, the organization argued.

The multibillion-dollar Warp Speed vaccine project's chief adviser, ex-GSK exec Moncef Slaoui, argues that continued digging into his ties to the biopharma industry could delay a vaccine. Interviewed on an HHS podcast, Slaoui railed at the media, BuzzFeed recounted, saying the ongoing scrutiny saps the energy of "all the teams" working to deliver a vaccine. Slaoui signed on at a $1 salary; soon after he was appointed, he resigned from Moderna's board and sold his shares amid allegations of a "huge conflict of interest." HHS ethics officers say he's since bowed out of advisory boards "with even an appearance of conflict," The New York Times reported.

Russia claims it's prepping a mass COVID-19 vaccination campaign in October, using a shot developed at Moscow-based Gamaleya Institute. Early clinical tests of the shot have wrapped up, CNBC reported, and the government says it spurred an immune response in all participants, with no side effects. Large phase 3 trials are set to begin this month, and the lab is already seeking regulatory approval. Critics worry that Russia will hustle its shot into use before it's proven safe and effective.

Physician researchers at Henry Ford Health System defended their real-world data study that backed hydroxychloroquine as a coronavirus treatment, even as follow-up trials found no benefits. It wasn't a gold-standard controlled trial, the doctors acknowledged in an open letter, but in a pandemic, that time-consuming standard may be a luxury. President Trump continues to tout the drug, while other administration officials say it's time to give up the idea. "Unfortunately, the political climate ... has made any objective discussion about this drug impossible," the researchers stated, adding that they won't offer any more public comments about it.

UPDATED: Monday, August 3 at 3:22 p.m. ET

Merck & Co. aims to push a COVID-19 vaccine into human testing by 2020's third quarter, the U.S. pharma said. The shot leverages a measles virus vector platform acquired via Merck's recent Themis buyout. Meanwhile, the drugmaker has also teamed up with IAVI to develop another shot that taps the same recombinant virus platform used in Merck's approved Ebola vaccine, expected to enter human studies later this year.  Story

With a number of high-profile vaccine candidates in late-stage trials and an election right around the corner, public health experts again warned that political pressure could push a shot toward approval before it's ready. The recent back-and-forth over discredited COVID-19 treatment hydroxychloroquine, coupled with reports that the Trump Administration may have pressured the CDC to change its school opening guidance, has created "a legitimate problem in public perception," former FDA chief scientific officer Jesse Goodman said.

The NIH’s Rapid Acceleration of Diagnostics initiative settled on seven COVID-19 tests to move into a new phase of evaluation and scale-up. Three of the finalist diagnostics—from Mesa Biotech, Quidel and Talis Biomedical—focus on rapid, in-person testing; the remaining four from Ginko Bioworks, Helix OpCo, Fluidigm and Mammoth Biosciences are made with lab-based testing in mind. Under phase 2 of the NIH program, the finalists will benefit from additional clinical testing, speedier review and $248.7 million in new funding. Story

The FDA approved its first serology tests that estimate the amount of COVID-19 antibodies in a person's bloodstream. Developed by Siemens Healthineers under the company's Atellica and ADVIA Centaur labels, the two recently-approved diagnostics build on assays greenlit in May as total antibody tests, which yield a positive or negative result based on the presence of antibodies rather than the "semi-quantitative" readout the new tests offer. Story

Meanwhile, the U.K. plans to roll out a free, nationwide COVID-19 screening effort, and the country's Rapid Test Consortium last Friday scored approval for a finger-prick blood test that it thinks is up to the task. Tens of thousands of the Abingdon Health-made devices were produced ahead of the green light, with a full launch slated for August's end. The company said it aims to produce 500,000 of the speedy antibody tests per month starting in October, while the larger consortium hopes to turn out 10 million tests over a six-month timeframe. Story 

The Trump Administration may have overpaid Philips by up to $500 million for ventilators during the early days of the COVID-19 outbreak, Democratic members of the House Oversight Committee say. What's more, the Department of Health and Human Services failed to capitalize on an earlier contract with Philips to provide 10,000 ventilators—priced at $3,280 per unit—to the national stockpile by 2019. Instead, the White House pushed those deadlines out to 2022 and inked a new $646.7 million order with the medtech giant in March. Story 

UPDATED: Monday, August 3 at 9:30 a.m. ET

A trio of rival drugmakers kicked off a joint study of three drugs that could combat the extreme immune response seen in severe coronavirus patients. The trial will test Amgen's psoriasis drug Otezla, Takeda's anti-inflammatory Firazyr and AbbVie's HIV hopeful cenicriviroc, each in combination with Gilead Sciences' remdesivir and the low-cost steroid dexamethasone. Early results could be ready in six weeks, the research alliance said. Story

Eli Lilly kicked off a phase 3 study of its experimental COVID-19 antibody to curb the virus' spread in U.S. nursing homes. The test aims to enroll up to 2,400 people employed or living at nursing homes where coronavirus cases have cropped up. The AbCellera-partnered antibody, dubbed LY-CoV555, is already being studied in hospitals as a treatment for the disease. Story

India's Wockhardt committed manufacturing space to help AstraZeneca build up British supplies of its Oxford University-partnered COVID-19 vaccine. The U.K. government has reserved one fill-finish line to produce vaccine supplies over the next 18 months, the company said. The financial terms and volume of the fill-finish pact are still under wraps. 

Meanwhile, the Serum Institute of India (SII) snagged a thumbs up from the country's drug regulator to run late-stage trials on the AstraZeneca-Oxford coronavirus vaccine candidate in healthy adults. SII aims to administer two doses to each subject four weeks apart. The candidate is also in testing in the U.K., Brazil and South Africa.

Plus, SII has one advantage in its quest to churn out hundreds of millions of COVID-19 vaccine hopefuls: As a business run by a billionaire family, it can take big financial risks, CEO Adar Poonawalla told the New York Times. Poonawalla is confident that the Oxford-AstraZeneca shot will pan out, and his company aim to have 300 million doses stockpiled for commercial use by the time trials finish around November. 

Oxford may be up against a cadre of well-funded pharma companies in the quest for an effective COVID-19 shot, but the school has its own web of investors who stand to profit if the candidate proves out.

U.S. coronavirus testing czar Dr. Brett Giroir said it was time to put the kibosh on hydroxychloroquine as a COVID-19 treatment. Giroir pointed to five separate trials disproving the drug's benefit in the disease. Giroir did not directly reference President Donald Trump, who in recent weeks has continued to tout the fallen treatment's use. 

UPDATED: Friday, July 31 at 9:25 a.m. ET

Sanofi and GlaxoSmithKline scored a whopping $2.1 billion under the U.S.' Operation Warp Speed vaccine program to hustle along clinical trials, scale up manufacturing and deliver an initial 100 million doses of their recombinant shot hopeful to the country. The partners' vaccine has yet to enter human studies, but its proven platform, already used in Sanofi's approved flu shot Flublok, could make it a more reliable option over the suite of vaccines relying on novel approaches like mRNA. Story 

Pfizer and BioNTech will deliver 120 million doses of their leading mRNA-based COVID-19 vaccine to Japan, starting in 2021. The financials are still under wraps, the companies said in a release. Recently, the vaccine partners signed a hefty $1.95 billion deal to deliver 100 million shots to the U.S., as well as a supply pact for 30 million doses in the U.K. Pfizer and BioNtech's shot entered late-stage testing this week. 

Last week, the U.S. accused two hackers with links to Chinese intelligence of targeting coronavirus research across the U.S. Now, Reuters has confirmed that Moderna was among the hackers' targets. For its part, China has denied the claims—both the initial hacking accusation and the new report that frontrunner vaccine maker Moderna was caught up in the cyber reconnaissance scheme.  

An approved COVID-19 vaccine could boast 90% efficacy, Operation Warp Speed head Moncef Slaoui said, adding that patients would likely need a booster dose after the first inoculation. Slaoui thinks there could be enough vaccines for the entire U.S. by mid-2021, or by the end of that year at the latest. Meanwhile, NIAID director Anthony Fauci previously said he was pinning his hopes on a vaccine that is 70% to 75% effective, while the FDA has set its efficacy guidance even lower at 50%.

Breaking with tradition, the CDC, which has long allocated vaccines during major outbreaks, will oversee nationwide COVID-19 vaccine distribution through a joint venture with the Department of Defense (DOD). The DOD will handle the actual shipments and allocation duties, while the CDC tracks vaccination side effects, plus "some of the communications" with state authorities and public health organizations, a senior administration official said. The move has drawn ire from state and local officials, who think military involvement could further undermine vaccine confidence. 

On average, the U.S. is currently performing more than 800,000 coronavirus tests per day, Axios reported, and turnaround times for results have stretched to a week or more, rendering those tests useless for many. The best way to ease the testing burden? Lower the U.S. case count, for starters. In the meantime, a push for smarter testing, focused on people who show symptoms or have come into contact with an infected person, could ease the massive diagnostic demand, health experts said. 

U.S. COVID-19 infections continue to rise, and without a unified national response to the outbreak, it's impossible to tell how long the pandemic will last in the U.S., NIAID director Anthony Fauci told CNN. Meanwhile, Dr. Michael Osterholm, an epidemiologist at the University of Minnesota, said he expects to deal with the virus for at least the rest of his lifetime, and warned against the expectation that an approved vaccine would signal the pandemic's end. 

And NIAID director Anthony Fauci, CDC director Robert Redfield and assistant secretary for health Adm. Brett Giroir are set to testify before a House special committee investigating the Trump Administration's pandemic response this morning. The top health experts are expected to discuss vaccines, coronavirus testing and the recent fracas over whether to send children back to school in the fall. 

UPDATED: Thursday, July 30 at 3:16 p.m. ET

AstraZeneca is one of many pharmas battling pandemic headwinds this year, but a stellar performance from its oncology division helped overall sales climb 9% in the second quarter. Lung cancer drug Tagrisso, Merck-partnered PARP inhibitor Lynparza, PD-L1 blocker Imfinzi and blood cancer therapy Calquence all surpassed analysts' expectations, with AZ's overall cancer sales soaring 24%. Meanwhile, respiratory sales fell 8%, largely due to the COVID-19 slowdown in one of the drugmaker's biggest markets, China. Story

Meanwhile, delayed patient starts due to COVID-19, plus a $250 million stockpiling reversal, led Eli Lilly to report a 2% sales decline in the second quarter, but the company could be entering a "period of earnings growth" thanks to the strength of its new medicines—which made up 42% of sales in the second quarter—and a lack of patent challenges on the horizon, one analyst figures. Lilly has also doubled down on its digital marketing platform amid the pandemic, CEO David Ricks said during an earnings call. Story

Sorrento Therapeutics snagged a rapid, saliva-based COVID-19 test from researchers at Columbia University that changes color when a positive sample is added. The COVI-TRACE test turns out results in under 30 minutes, changing from red to yellow if viral RNA is detected. If the test scores a green light, it could help screen people before they board planes, visit nursing homes and more, the Columbia research team said. Story

ExeVir Bio picked up €23 million ($27 million) to advance its llama-derived, single-domain antibodies (VHHs) against COVID-19. The VHHs, created by immunizing llamas with coronavirus spikes, are smaller than typical antibodies and can bind to otherwise unreachable parts of the virus. Plus, those single-domain antibodies can be nebulized and administered with an inhaler—a potential boon for treatment of respiratory diseases like COVID-19. ExeVir hopes to push its llama-generated antibodies into the clinic by year-end. Story

Most leading COVID-19 vaccine candidates rely on the virus' spike protein to trigger an antibody response, but as more research emerges showing that antibody levels could drop in recovered patients, researchers are turning to another immune indicator: T cells. By studying memory CD8+ T cells in recovered COVID-19 patients, researchers from TScan Therapeutics pinpointed the most common viral targets of those cells, the majority of which were not located on the virus' spike proteins. Spotlighting those new targets "could form the basis of a next-generation vaccine," the research team said. Story

UPDATED: Thursday, July 30 at 11:15 a.m. ET

A single dose of Johnson & Johnson's adenovirus-based COVID-19 shot spurred a "robust immune response" in a preclinical study published in Nature. On the strength of that data in non-human primates, J&J pushed its candidate into its first stage of human testing in the U.S. and Belgium, with an expected phase 3 start in September, chief scientific officer Paul Stoffels, M.D., said in a release. The company aims to enroll about 1,000 patients aged 18 to 55 in the current phase 1/2a, and also plans to test its shot in patients over 65. Both the current trial and future late-stage studies will test single-dose and two-dose regimens. 

Companies in the private sector—which have led the charge on COVID-19 vaccine, drug and testing work during the pandemic—ought to make a return on their efforts, Pfizer CEO Albert Bourla told Barron's. With both Moderna and Pfizer and BioNTech's mRNA-based vaccine candidates in late-stage testing, a fresh round of debates has kicked off between politicians and health experts over vaccine pricing and the greater public good once a shot passes the finish line. Story

AstraZeneca is eyeing potential booster doses for its COVID-19 vaccine candidate, possibly every 12 to 18 months if the shot ends up working, CEO Pascal Soriot told CNBC. Soriot was quick to qualify those claims: "But the truth is we don't know, this virus is very unpredictable." Currently, Moderna and Pfizer are also anticipating the need for at least two doses of their frontrunner vaccine candidates to confer immunity. 

A powdered formulation of Gilead Sciences' remdesivir could prove more potent and easier to administer, thanks to researchers at the University of Texas at Austin who have used their novel thin-film-freezing technology to create an inhaled form of the antiviral COVID-19 treatment. Remdesivir is currently given to patients via IV; by developing an inhaled version, the antiviral might reach more patients, prevent contact between infected individuals and health care workers, and lessen symptoms before they become potentially fatal, the research team said.

Hydroxychloroquine will no longer be available to treat COVID-19 in Ohio, the state's pharmacy board ruled. Despite the FDA's retracted emergency authorization for the drug in COVID-19 in June, patients in Ohio could still technically take the antimalarial off-label to treat the disease. The pharmacy board insisted that the move wasn't tied to recent attempts by President Donald Trump—as recently as this week—to push the fallen treatment despite widely published data on its ineffectiveness in COVID-19. 

UPDATED: Wednesday, July 29 at 3:01 p.m. ET

A group of scientists in Boston formed a group to create a do-it-yourself experimental vaccine that's administered through the nose, raising legal and ethical questions, MIT Technology Review reports. At least 20 people have given themselves the unproven vaccine.

Sanofi's Dupixent was among a group of specialty care medicines that posted sales increases during the first half of the year despite the pandemic. The company is in "very late" stage negotiations with Europe and the U.S. on COVID-19 vaccines, and expects a "record" flu season, its CEO said.

Shortly after reporting that Shingrix supply has recovered, GlaxoSmithKline says sales for the shingles vaccine fell sharply in the second quarter. Sales dropped 19% at constant exchange rates to  £323 million ($419 million) as lockdowns delayed vaccinations. Other vaccines in the company's portfolio also posted sales declines, while respiratory sales jumped.

Amgen's newly acquired Otezla helped boost the company amid challenges from COVID-19. During the second quarter, sales for the drug grew 14% year-over-year due to the oral psoriais med's convenience edge over injectable rivals. Elsewhere, the pandemic hurt Prolia, Nplate and Xgeva, execs said, but white blood cell booster Neulasta Onpro benefited. 

UPDATED: Wednesday, July 29 at 9:25 a.m. ET

Developed nations making advance purchase deals for Pfizer's mRNA-based coronavirus vaccine should expect to pay no less than the $19.50-per-dose price tag set under the drugmaker's recent U.S. supply pact, CEO Albert Bourla said. The full two-dose course will run for $39 in the U.S. 

The U.K. inked a deal to secure 60 million doses of Sanofi and GlaxoSmithKline's COVID-19 vaccine candidate, set to enter human trials in September. The country has also forged vaccine supply pacts with AstraZeneca, Valneva and Pfizer and BioNTech, rounding up 250 million potential doses so far. The financial terms of the Sanofi-GSK deal have not been made public. Story

Vaccine experts raised alarm bells—again—over the threat of political pressure to hastily approve a COVID-19 shot before the year is out. Experts' biggest fear? "Truncated" late stage trials that could see a shot cross the regulatory finish line without a full understanding of its safety and efficacy, said Paul Offit, M.D., president of the Vaccine Education Center at Children’s Hospital of Philadelphia. 

Takeda's CoVIg-19 Plasma Alliance has supplies of an experimental blood plasma treatment for COVID-19 ready to go, but with approval to run clinical trials pending, the partners are unlikely to meet their planned July start date. Under the alliance, Takeda is working with Biotest AG, CSL Behring and Octapharma Plasma to develop a hyperimmune globulin therapy derived from convalescent plasma. If the treatment wins out in the clinic, the companies aim to file for regulatory approval before year's end, said Takeda's U.S. plasma therapies president Julie Kim.

The E.U. handed over €63 million ($74 million) to Gilead Sciences for enough doses of its antiviral remdesivir to treat 30,000 COVID-19 patients. The initial supply deal will satisfy "immediate needs," the European Commission said, adding that it hopes to secure more doses in October. 

Meanwhile, hospitals in U.S. regions hard-hit by COVID-19 reported widespread shortages of Gilead's remdesivir. While the U.S. government started sending out remdesivir shipments after trials confirmed its benefit in COVID-19, doctors have blasted its distribution model; overwhelmed hospitals have missed out on deliveries while clinics in regions with lower case counts received ample supply. 

And Kodak rolled out a new pharmaceutical division, backed by $765 million from the U.S. government, to create active ingredients for critical drugs in short supply. Among the medicines Kodak will reportedly produce? Discredited COVID-19 treatment hydroxychloroquine, which had its emergency approval in COVID-19 revoked in June. 

UPDATED: Tuesday, July 28 at 3:18 p.m. ET

Canada gave a conditional OK to Gilead Sciences' remdesivir to treat patients with severe COVID-19, now the first approved coronavirus treatment in the country. Singapore, Japan, the U.S. and other countries have also granted conditional approval for Gilead's drug in COVID-19. 

Pfizer stands to earn $15 billion—at least—under its recent $1.95 billion vaccine supply deal with the U.S., Bloomberg Intelligence analyst Sam Fazeli figures. A single dose regimen under the 100-million-dose supply pact would generate $19.50, netting the company $15 billion if the shot wins out in the clinic. And at the two-dose regimen Pfizer is eyeing, the $39 price per course would still run about 30% cheaper than an annual flu shot. Pfizer's supply deal also includes an option for an extra 500 million doses, which could drive sales even higher. Story

Meanwhile, Pfizer is the latest major pharma to report pandemic-related sales declines in the second quarter, but some successes in its branded drug business pushed the drugmaker to dial up revenue expectations for 2020. One thing Pfizer isn't counting on to boost full-year sales figures? Its BioNTech-partnered COVID-19 vaccine, which entered late-stage testing Monday. Story

COVAX, an equitable COVID-19 vaccine distribution initiative backed by Gavi, The Vaccine Alliance, the World Health Organization and the Coalition for Epidemic Preparedness Innovations (CEPI), has set its maximum vaccine price at $40 for high-income countries, and aims to negotiate tiered pricing to bring that cost down even further in both richer and poorer nations, GAVI chief and COVAX co-head Seth Berkley told Reuters.

A genetic mutation that boosts SARS-CoV-2's ability to infect human cells could also make it a better target for vaccines, according to early research uploaded to "eprint" distributor medRxiv. The mutation, dubbed D614G, increases the number of spike proteins on the virus, allowing it to infect cells more efficiently. The good news? That spike protein increase provides more neutralizing antibody targets for the COVID-19 vaccines currently in clinical studies.

U.S. President Donald Trump took to Twitter Monday night to gin up support—again—for fallen COVID-19 hopeful hydroxychloroquine, despite numerous studies confirming that drug's ineffectiveness against the virus. NIAID director Anthony Fauci bit back Tuesday morning with support for the FDA's decision to nix emergency approval of hydroxychloroquine in COVID-19 last month. 

UPDATED: Tuesday, July 28 at 9:13 a.m. ET

Pfizer and BioNTech launched their late-stage vaccine trial Monday, kicking things off in the U.S. with plans to expand the study to around 120 sites globally. The partners will administer their nucleoside-modified messenger RNA (modRNA) candidate in a two dose, 30 microgram regimen to an expected 30,000 patients aged 18 to 85 years. Moderna also pushed its mRNA-based shot into late-stage testing Monday, and like Moderna, Pfizer and BioNTech think their shot could win a speedy approval before year-end if it triumphs in the clinic. Story

Moderna's 2020 delivery of a safe and effective coronavirus vaccine is a "stretch goal," National Institutes of Health director Francis Collins said, "but it's the right goal for the American people." Meanwhile, NIAID director Anthony Fauci said trial results could arrive by November, December or possibly even earlier—plus, Fauci is confident in the shot's safety after reviewing early trial data. 

But Moderna would do well to keep quiet about its trial results timeline, CNBC's Jim Cramer said. By pinning down late-stage readouts to the early fall, the Massachusetts-based biotech could affect political decisions about stimulus packages and other measures, Cramer said. Meanwhile, Moderna execs' stock sales could portray the company in a negative light given its massive backing from the U.S. government. 

Indeed, executives from vaccine makers big and small are teeing up payouts—some quite large—even if their companies' shots fail to pan out. Moderna CEO Stéphane Bancel ginned up $21 million in stock sales during the first half of the year, while Chief Medical Officer Tal Zaks reaped $8 million in July alone. Novavax has set up options for several executives, together worth more than $100 million, to be awarded as soon as their shot enters phase 2. And small firm Vaxart doled out stock options worth millions to company insiders weeks before it announced its Warp Speed support.

Fujifilm Diosynth will pivot its College Station, Texas, plant to churn out COVID-19 vaccine doses under a new task order from BARDA. The CDMO's Flexible Biomanufacturing Facility will provide shot manufacturing capacity through 2021, and Fujifilm will speed up its planned expansion of the site by several months with the new deal's backing. That upgrade should be complete by the fall, Fujifilm said. 

But prospects look dim for Fujifilm's Avigan as an approved COVID-19 treatment in Japan. The flu med, known generically as favipiravir, turned out inconclusive results in a trial by Fujita Health University this month, while Fujifilm's own late-stage study is still locked in the recruitment phase. Japan's Prime Minister, Shinzo Abe, previously floated a potential approval for the drug in COVID-19 by May, but Fujifilm has yet to submit Avigan for regulatory review. 

U.S. biotech AI Therapeutics pinpointed a potential COVID-19 antiviral via an artificial intelligence algorithm that matches drugs to new indications. The company has launched a phase 2 on the drug, known as LAM-002A, with support from Yale University, and plans to recruit up to 142 patients to test safety and efficacy, including endpoints on the antiviral's effect on death rates, hospitalizations and oxygen saturation. The drug could also work as a combination therapy with other treatments that target viral proteins and functions, the researchers said. 

UPDATED: Monday, July 27 at 3:15 p.m. ET

Moderna kicked off its phase 3 coronavirus vaccine study across 89 U.S. clinical research sites Monday, with results expected as early as November, government and health officials said. Patients will receive two doses of the mRNA-based shot about four weeks apart, with researchers comparing immune response between the vaccine and placebo arms two weeks after the second dose. 

EU talks with a trio of drugmakers to secure COVID-19 vaccines stumbled over liability costs, pricing and payment timelines, three EU officials told Reuters. Johnson & Johnson and the EU are reportedly in the advanced stages of a deal but have butted heads over how to split potential side effect liability costs. Meanwhile, Sanofi hopes to secure payment upfront for its shot, while the Union would prefer to pay in tranches; and Pfizer has offered to sell 500 million doses on the condition that its shot wins approval, spurring EU uncertainty about whether to act now, or wait for the regulatory thumbs up—and a potentially higher price tag. Story

New York City-based biopharma Immunic Therapuetics launched a phase 2 study of its oral dihydroorotate dehydrogenase enzyme (DHODH) inhibitor, IMU-838, in moderate to severe COVID-19 patients. The trial, which aims to include around 120 adult participants, will compare Immunic's DHODH inhibitor paired with Roche flu med Tamiflu, or oseltamivir, against Tamiflu alone. IMU-838 successfully thwarted reproduction of the virus in preclinical studies, Immunic said. 

LabCorp's coronavirus diagnostic test scored a green light for use in people without COVID-19 symptoms. Previous FDA approval for the test was limited to patients with early signs of infection such as fever, along with high-risk individuals and front-line healthcare workers. The agency also OK'd LabCorp's diagnostic for use in pool testing, which sees up to five coronavirus testing samples processed at once. Story

And the COVID-19 outbreak "is easily the most severe" health crisis the World Health Organization has grappled with, director general Tedros Ghebreyesus said Monday. Ghebreyesus went on to defend the organization's pandemic response, citing its declaration that the virus posed an international health risk in late January. Ultimately, the willingness of countries like New Zealand and Germany to act quickly on WHO guidance prevented outbreaks or curbed case counts, Ghebreyesus said. 

UPDATED: Monday, July 27 at 9:18 a.m. ET

The Biomedical Advanced Research and Development Authority (BARDA) upgraded its contract with Moderna, pledging an extra $472 million to support late-stage shot development and fund the drugmaker's 30,000-patient phase 3 vaccine trial—set to begin Tuesday, the company said. Moderna previously snagged $483 million from BARDA to support development of its mRNA-based coronavirus vaccine. Story

The Serum Institute of India aims to file applications for a 4,000 to 5,000-patient phase 2/3 trial of AstraZeneca and the University of Oxford's COVID-19 vaccine at 11 to 12 Indian hospitals, CEO Adar Poonawalla said. If the shot passes muster in the clinic, the Serum Institute will kick off distribution across India and 60 to 70 GAVI-partnered nations, with the goal to churn out 300-400 million doses by year's end. 

Emergent BioSolutions penned a $174 million deal with AstraZeneca to help manufacture doses of the British drugmaker's Oxford-partnered shot at its Baltimore Bayview plant, pegged by the U.S. Department of Health and Human Services to rapidly deploy large sums of drugs and vaccines. In June, AstraZeneca tapped Emergent to serve as a manufacturing partner on its vaccine hopeful, handing the Maryland-based biopharma $87 million. Story 

Popular heartburn med Pepcid—known generically as famotidine—does not prevent COVID-19 infection or improve patients' symptoms, early study results posted on preprint repository bioRxiv showed—at least not as an antiviral. In two different tests, scientists from Bisect Therapeutics and Boston University School of Medicine found that Pepcid failed to dock with and inhibit enzymes known as proteases, which help the virus replicate—but the drug may still show some promise as a treatment for hyperimmune reactions in COVID-19 patients, the researchers said. 

Fujifilm Diosynth's Morrisville, North Carolina, plant will receive a special guest this afternoon: U.S. President Donald Trump. The President will tour the site—in a mask—where Fujifilm is working on components of Novavax's COVID-19 vaccine hopeful, one of several shots boosted by Operation Warp Speed funding. 

And President Donald Trump is talking up progress on COVID-19 drugs and vaccines to restore faith in his administration ahead of November's election, Axios reported. The move aims to deflect criticism over the President's handling of the pandemic. If he "...offers people a light at the end of the COVID tunnel, he's gonna be in a lot stronger position to win reelection than I think a lot of people think right now," an administration official said. 

UPDATED: Friday, July 24 at 3:15 p.m. ET

A COVID-19 slowdown and biosimilar competition led Roche to report its first quarterly sales slump in nine years—but demand for coronavirus testing boosted molecular diagnostic sales by 61% in 2020's first half. Roche's overall diagnostic sales jumped 3% to CHF 6.1 billion ($6.6 billion) in that time. Roche has launched commercial and research-focused coronavirus diagnostics, plus an antibody test and an IL-6 immune system test to detect severe COVID-19 cases. Story

Several states and major pharmacy chains like CVS are seeking alternatives to private labs Quest Diagnostics and LabCorp as those companies struggle to deliver COVID-19 testing results in a timely manner. On Monday, Quest said turnaround times had slowed to a week or more—defeating the purpose of the tests for those who cannot quarantine that long on an uncertainty. Now, states such as Montana, Florida and others are turning to universities, other private labs and expedited testing lines to pick up the pace. Story

Researchers from the University of Texas at Austin created a synthetic version of the SARS-CoV-2 spike protein—target of many leading vaccine candidates—that produces up to 10 times more protein than an earlier synthetic version already used in Moderna and Novavax's shots. The modified protein, dubbed HexaPro, could reduce the size of future shot doses and speed up vaccine production, the research team said. 

Getting children back in the classroom is key, but schools need to make the call to reopen on a local level, NIAID director Anthony Fauci told the Washington Post. Districts where the virus is still rampant should consider alternating schedules and hybrid learning, Fauci said. On Thursday, the CDC released new guidance urging schools to reopen in the fall. 

UPDATED: Friday, July 24 at 9:08 a.m. ET

Canadian biopharma Arbutus holds the rights to nanoparticle technology used in Moderna's frontrunner COVID-19 vaccine, the U.S. Patent and Trademark Office ruled. Arbutus' lipid nanoparticles help mRNA strands reach their cell targets, and if the small biotech chooses to seek an injunction, it could block Moderna from selling its vaccine. Moderna is now left with two likely choices: Challenge Arbutus' patent—again—or hash out a licensing deal.  

The chairman of Swiss drugmaker Lonza previously voiced concerns about staff and equipment shortages that could affect its vaccine manufacturing deal with Moderna. But now, Lonza is preparing small shot batches for Moderna's upcoming phase 3 and thinks those concerns are a thing of the past, thanks to "strong support" from the U.S. government, chairman Albert Baehny said. 

Novavax enlisted CDMO Fujifilm Diosynth Biotechnologies to churn out doses of its protein-based COVID-19 vaccine, with production already underway at Fujifilm Diosynth's Morrisville, North Carolina, site. The pact will draw on Novavax's recent $1.6 billion funding deal with the Warp Speed vaccine program, the company said. Batches from the Fujifilm site will be used in Novavax's upcoming phase 3 trial, set to begin this fall. Story

The U.S. Department of Justice gave its blessing to an information-sharing initiative between Eli Lilly, Amgen, AbCellera, Roche's Genentech unit, AstraZeneca and GlaxoSmithKline to help the drugmakers scale up manufacturing of COVID-19 antibody therapies ahead of regulatory approvals. Regeneron, expecting trial results on its antibody cocktail this summer, was excluded from the list. 

Once-hyped COVID-19 treatment hydroxychloroquine took another blow, this time from a study published in the New England Journal of Medicine that showed the antimalarial did not improve patient outcomes. Conducted across 55 Brazilian hospitals and in 667 mild to moderate COVID-19 patients, the trial showed hydroxychloroquine alone or paired with the antibiotic azithromycin delivered no improvement compared with placebo. It did, however, trigger more side effects like heart rhythm irregularities.

NIAID director Anthony Fauci thinks a return to normalcy could come in 2021 with sufficient COVID-19 vaccine production. The infectious disease expert said several top shot makers told him "that they would have doses to the tune of tens of millions early in the year, and up to hundreds of millions as we get well into 2021." Another unexpected update? Fauci stressed Thursday that he had "quite a good" relationship with President Donald Trump, despite recent efforts by the current administration to discredit him. 

UPDATED: Thursday, July 23 at 3:25 p.m. ET

COVID-19, plus an onslaught of cancer biosimilars, fueled Roche's first quarterly sales decline since 2011—and the virus remains a "moving target" for the Swiss drugmaker, pharma chief Bill Anderson said during an investor call. The company's focus on "...specialized medicines, which are typically administered in a professional setting," hit Roche hard as COVID-19 lockdowns went into effect, CEO Severin Schwann added. Meanwhile, sales of Roche's Actemra—repurposed for off-label use in severe COVID-19 pneumonia—jumped 40%. Story

With drugmakers funneling resources toward COVID-19, biopharma M&A has taken a major blow. Between the second half of 2019 and the first half of 2020, deal value in pharma plunged 56% to $7.7 billion, PwC found. Meanwhile, biotech deal value fell 74% to $12.6 billion. The good news? At least one PwC analyst expects M&A activity to pick up in 2020's second half, with oncology and gene and cell therapy likely targets. Story

It may take multiple doses of an approved COVID-19 vaccine to grant immunity, Bill Gates said Wednesday, which could require over 7 billion vaccinations globally. Moderna's frontrunner shot will require two doses a month apart, and at Tuesday's Congressional hearing, AstraZeneca R&D executive Mene Pangalos said the drugmaker was eyeing multiple doses for its University of Oxford-partnered candidate, too. 

Despite the recent flurry of vaccine data, inoculations are unlikely to start until early 2021, the World Health Organization's emergencies program head Mike Ryan said Wednesday, encouraging the public to continue following safety guidelines to curb the virus' spread. Ryan added that the WHO was working to ensure broad access for an approved COVID-19 shot: "Vaccines for this pandemic are not for the wealthy, they are not for the poor, they are for everybody."

Lasers could shine a light on the body's immune response to COVID-19 where antibody tests fall short. Adarza Biosystems is developing arrayed imaging reflectometry (AIR) tech that uses reflective well plates, capture probes and lasers to provide a high-definition picture of multiple viral antigens at once, rather than the narrow, single-antigen focus of most COVID-19 antibody tests. Adarza first started developing its AIR tech for immuno-oncology and cell therapy purposes, but it quickly pivoted its research to tackle COVID-19. Story

Researchers at Columbia University pinpointed nine "very potent" antibodies that could neutralize COVID-19 and prevent infection in people sensitive to vaccines. Like Regeneron's antibody cocktail, the researchers' use of multiple antibodies cuts the risk of the virus becoming treatment-resistant, project lead David Ho said. Animal trials of the antibodies are already underway, and the team hopes to launch early human studies by October. 

Reported U.S. coronavirus infections breached 4 million Thursday, according to a Reuters tally, jumping from 3 million in just 16 days. The rapid spike in new infections comes as state and local leaders butt heads over the use of masks and debate whether to open schools in the fall. 

UPDATED: Thursday, July 23 at 10:40 a.m. ET

Pfizer and BioNTech's $1.95 billion deal to supply 100 million vaccine doses to the U.S. drew ire from watchdogs, who warned that the move could lead to price-gouging later. The agreement includes an option for 500 million more doses at an as-yet-undetermined price. AstraZeneca and Johnson & Johnson both pledged to sell vaccines at no profit to the U.S.—which has shelled out funding for development in both cases—while Pfizer has expressed interest in making at least a marginal return on its shot. Meanwhile, SVB Leerink's Geoffrey Porges thinks Pfizer set a reasonable "benchmark" for future vaccine price tags and warned that firms pledging to market shots at zero profit could put negative pressure on vaccine innovation for years to come. Story

The European Medicines Agency set up a new observational research effort to study COVID-19 vaccines and treatments in real-world clinical practice. The EMA first tapped the vACcine Covid-19 monitoring readinESS (ACCESS) project in May to lock down research and data resources for the future study of an approved vaccine, followed by a contract with IQVIA to study the use of drugs in COVID-19 patients. In July, EMA rounded out its research effort by allying with Utrecht University to collect data on the virus' impact in pregnant women. 

The U.K. will pump £100 million ($127 million) into an upgrade of a Cell and Gene Therapy Catapult manufacturing plant in Essex to churn out millions of vaccine doses each month, once a shot wins approval. CGT has already partnered with the government to construct the Vaccine Manufacturing and Innovation Center, plus a rapid deployment center that will come online this summer. The U.K. also provided CGT with £4.7 million ($5.9 million) for training sites and online learning platforms to dispense gene therapy and vaccine know-how to future staffers. 

Sinopharm's COVID-19 vaccine candidate could roll out for public use by the end of the year, China reported Wednesday. In June, the state-owned firm delayed its expectations for an approved shot until 2021, citing a lack of trial participants at home. Since then, Sinopharm launched a 15,000-person phase 3 in the United Arab Emirates. Late-stage trials are set to wrap in about three months, Sinopharm chairman Liu Jingzhen said. 

The National Institutes of Health aims to launch a "flurry" of large-scale studies on experimental COVID-19 treatments, director Francis Collins said, targeting monocolonal antibodies for use in the hospital and at home; immunosuppressants; and blood thinners to combat blood clots in severely ill patients. 

Eleven major U.S. cities hit with new COVID-19 outbreaks must take "aggressive" steps to curb the virus' spread, coronavirus task force member Deborah Birx told state and local leaders Wednesday. Baltimore, Cleveland, Las Vegas, Miami and more were included on Birx's list. Her recommendation? Ramp up contract tracing for patients who test positive in areas where case counts are on the rise. 

UPDATED: Wednesday, July 22 at 3:20 p.m. ET

The University of Oxford's AstraZeneca-partnered COVID-19 vaccine could grant lasting immunity to the virus, but patients will likely need two initial doses and one to two annual boosters after that, Vaccitech CEO Bill Enright told FiercePharma. Vaccitech, spun out from Oxford's Jenner Institute, has quietly worked with the university on its shot candidate since January. The shot's viral vector platform could also give it an edge in T-cell response over leading mRNA hopefuls, which may help "drive immune memory if neutralizing antibodies fall over time," Enright said. Story

Under a new incentive plan, Novavax CEO Stanley Erck and three other executives are set to receive a payout worth about $101 million if the firm's Warp Speed-backed vaccine makes it into phase 2, Reuters reported. The stock options were granted to retain talent and recognize the executives' efforts, Novavax said. Meanwhile, executive compensation experts and watchdogs blasted the company for pinning the award to an interim milestone, rather than full vaccine approval. Story

The U.S. ordered an additional 140 million needles and syringes from medtech giant BD as the country prepares for a potential COVID-19 vaccine approval by the end of the year. Meanwhile, Canada nearly doubled its order to 75 million injection devices. Most of BD's international orders, including more than 100 million injectors set aside for the U.K., are slated for delivery before year-end, the company said. Story

Treating COVID-19 patients with steroids is a bit of a double-edged sword: Administer the drugs too early, and the patient's immune system gets tamped down before it can fight the virus. Provide them too late, and the damage is already done. Now, researchers at Montefiore Medical Center have highlighted a cheap blood test measuring C-reactive protein—an inflammation indicator—in COVID-19 patients' blood that could help pinpoint the perfect time to administer steroids for maximum effect—and minimum damage. 

The Northeastern U.S. bore the brunt of COVID-19 in the early days of the pandemic; now, it's leading the way in virus response while the rest of the country grapples with new infections. The reason for the region's success? Strict lockdowns, major investments in testing and tracing, and strong public adherence to safety measures. Six of the 11 states that currently boast flat or falling case counts are situated along the east coast. 

UPDATED: Wednesday, July 22 at 9:15 a.m. ET

Pfizer and BioNTech nabbed a $1.95 billion deal with the U.S. HHS and the Defense Department to deliver 100 million doses of their vaccine candidate, regulatory approval pending. The U.S. has kept an option on the table to order an additional 500 million doses. The Pfizer-BioNTech supply deal supports Operation Warp Speed's goal to start deploying 300 million COVID-19 vaccine doses in 2021. Story

Brazil aims to lock down doses of Moderna's mRNA vaccine hopeful, and talks with the U.S. biotech are already underway, the country’s interim Health Minister Eduardo Pazuello said. Brazil has another deal in place to secure 30 million doses of AstraZeneca and the University of Oxford's shot. 

The public should place their faith in any COVID-19 vaccines that eventually win FDA clearance, executives from AstraZeneca, Johnson & Johnson, Merck, Moderna and Pfizer said at a Congressional hearing Tuesday. The agency continues to maintain strict regulatory standards amid the pandemic, the executives said, even as companies rush to hustle a shot toward approval before year's end. 

CEO Vas Narasimhan, with 10 years of experience leading Novartis' vaccine unit under his belt, said the company has no interest in joining the race for a COVID-19 vaccine. "My own experience in vaccines teaches me that it's difficult to, de novo, build scale and expertise to be able to develop large scale vaccines successfully," Narasimhan said. Instead, the Swiss drugmaker has set its sights on drugs and treatments to combat COVID-19 and future coronaviruses. 

Japan's health ministry gave low-cost steroid dexamethasone the OK for use in COVID-19 patients. The drug, first shown to slash death rates in hospitalized COVID-19 patients in a widely-publicized U.K. trial, joins Gilead Sciences' remdesivir as the second treatment approved by Japan against COVID-19. 

India's Glenmark Pharmaceuticals published data from a phase 3 study on its Avigan generic favipiravir, sold by the firm as FabiFlu. Of the 150 mild to moderate COVID-19 patients trialed, those dosed with the flu med met "clinical cure" status after a median of 3 days, compared with 5 days among the control group. The drug also seemed to delay the time it took for critically ill patients to require oxygen support. 

In his first pandemic-related press briefing in months, President Donald Trump reversed his stance on masks to combat the spread of COVID-19, asking everyone to wear one when social distancing isn't possible. Trump added that the outbreak was likely to worsen before it improved. 

Czech health authorities tallied 212 new COVID-19 cases Tuesday night, bringing the country's total active case count to a record 5,046. The nation has only reported 360 deaths from the virus—far fewer than some other European countries—but new infections have climbed following an outbreak at a mine in the north-eastern region of the Czech Republic.

UPDATED: Tuesday, July 21 at 3:21 p.m. ET

Merck inked a deal with Italian biopharma IRBM to identify and develop novel peptide therapeutics to treat coronaviruses, including SARS-CoV-2. The companies are keeping quiet on the deal, with no stated target or mechanism of action for the experimental therapy, but peptides have previously shown success treating other viruses like HIV and SARS-CoV. Story

The FDA relaxed regulations on viral transport media used in COVID-19 diagnostics to ease the burden on testing supplies. Under the guidance update, commercial manufacturers can ship their products immediately without the need for a formal, 90-day new medical device application, and the FDA will suspend its product quality system and manufacturing regulations. The agency asked companies producing viral transport media to abide by ISO standards and slap labels on their products post-company validation that state they haven't been FDA-reviewed. Story

Novartis' top line growth in the early days of the pandemic proved short-lived, with the drugmaker reporting a 4% sales drop in 2020's second quarter. In addition to an ophthalmology franchise slump, Novartis' top seller Cosentyx—used to treat psoriatic arthritis and plaque psoriasis—performed below analyst expectations due to slower patient starts in skin health; at the peak of the COVID-19 outbreak, dermatologist visits plunged 50% in the EU and 80% to 90% in the U.S., the Swiss drugmaker said. Story

Glenmark Pharmaceuticals deflected criticism from India's drug regulator over pricing and efficacy claims about its Avigan generic FabiFlu in COVID-19, citing the drug's lower price point in India compared to Avigan's cost in other countries. Plus, the drugmaker denied touting the flu med's safety in COVID patients with co-morbid conditions; those claims came instead from Japanese registries linked to outside Avigan trials, Glenmark said. 

Two hackers conspired with Chinese intelligence to test the cyber security of at least four American companies working on COVID-19 research starting in January, a U.S. indictment claimed. The Trump administration publicly accused China of trying to steal intellectual property linked to the pandemic in May, which China denied. Last week, the U.S., U.K. and Canada also accused a hacker group with ties to Russian intelligence of plotting to swipe Western COVID-19 research. 

How much will an approved COVID-19 shot cost? Some Big Pharmas like Johnson & Johnson and AstraZeneca have pledged to market their vaccines at no profit during the pandemic, while others like Novavax and Pfizer aim to balance affordable access with a marginal return. Then there are the undecideds: drugmakers like Sanofi—which has two vaccine projects in the works—and Merck, both still in talks with governments, partners and payers to make their final vaccines low cost and widely available. Story

With many pharmas unloading data on their COVID-19 vaccine frontrunners in rapid succession, it's difficult to cut through the hype. Candidates from AstraZeneca, Pfizer, Moderna and more are now locked in an all-out data race, but analysts are undecided on which shot could prove most effective and comparing trials is a risky proposition. Plus, more inclusive studies targeting a broad spectrum of races and age groups are needed to develop a shot that yields true immunity. Story

UPDATED: Tuesday, July 21 at 9:20 a.m. ET

Merck CEO Ken Frazier made waves last week when he challenged expectations of a COVID-19 vaccine before year's end. But NIAID chief Anthony Fauci rebutted Frazier's position, standing by his and the current administration's goal to deliver a shot before 2021. "I don't think that's outlandish at all," Fauci said. 

On the heels of an early trial data release, the University of Oxford's lead vaccine developer Sarah Gilbert said the AstraZeneca-partnered shot could roll out by year's end, but added there was "absolutely no certainty" until the partners hit three vaccine checkpoints: the shot needs to succeed in phase 3, have manufactured doses in place and score emergency approval from regulators.

And with the AstraZeneca-Oxford early vaccine data revealed, SVB Leerink analysts figure the partners' shot is about on par with T-cell response triggered by Pfizer and BioNTech's mRNA hopeful. The latter vaccine already has Moderna beat in that field, the analysts said, with the caveat that it's almost impossible to judge true clinical efficacy from phase 2 stats. Meanwhile, CanSino also released phase 2 data yesterday, with benefits—and side effects—roughly in tune with the other shots caught up in the data publishing spree. 

South Korea's SK Bioscience is the latest firm tapped by AstraZeneca to manufacture doses of its Oxford-partnered shot candidate. SK is set to churn out vaccine solution starting this month; the current contract lasts into early next year, but the deal could be expanded if the shot wins approval, SK said. 

Comprehensive enrollment in COVID-19 drug and vaccine trials has become a hot button issue, and exclusion of the elderly is the latest slight to come to researchers' attention. Dr. Sharon K. Inouye of Harvard Medical School and Hebrew SeniorLife found that 37 of 241 reviewed trials set age limits as low as 65 years, while another 27 trials set no maximum, but excluded patients with illnesses common in older populations. The lack of diverse data could pose a serious threat given that 80% of American COVID deaths have occurred in those over age 65. 

Fujifilm will team up with India's Dr. Reddy's Laboratories to run a 1,000-person trial on flu med Avigan in coronavirus patients in Kuwait. The trial was originally slated to run in Japan, but low patient enrollment forced Fujifilm to relocate. In early July, Fujifilm granted Dr. Reddy's a license to produce and sell Avigan as a potential COVID-19 treatment overseas in partnership with Global Response Aid.  

China selected Egypt to serve as a manufacturing hub for a COVID-19 vaccine in Africa—if that shot passes muster in Beijing. Egypt's health ministry confirmed Monday that a deal was forged between the country's national vaccination center, Vacsera ,and an unnamed Chinese pharma with a shot in clinical studies. Manufacturing is set to begin in Egypt once development of the shot wraps. 

U.S. Surgeon General Dr. Jerome Adams is stepping up as the face of a new public service campaign that will tap leading scientists, celebrities and sports figures to talk about following public health guidance during the pandemic. Adams has faced criticism from multiple angles during the outbreak, both as a scientist and an African American working under a president routinely accused of racism, but the surgeon general is undeterred. "I have a powerful opportunity to have an influence in this administration," Adams said. "That's how I deal with it."

NIAID director Anthony Fauci will throw out the first pitch this week on Opening Day for the Washington Nationals Major League Baseball team. The Nationals called Fauci a "true champion" for the country during the COVID-19 pandemic and in a statement said it is fitting that he do the honors as the team starts its season to defend its World Series champion title. Fauci, who sported a Nationals logo mask while testifying before a Congressional hearing last month, will take the mound—in an empty stadium—in Washington D.C. on Thursday. 

UPDATED: Monday, July 20 at 3:30 p.m. ET

Russian drugmaker R-Pharm inked a new licensing deal for supplies of AstraZeneca and the University of Oxford's COVID-19 vaccine candidate, which it will distribute in Russia and eight other post-Soviet republics, plus the Balkans and the Middle East, AstraZeneca confirmed. Russia cited the deal to fend off last week's accusations that hackers tied to its intelligence agency tried to steal Western COVID-19 vaccine research. Story 

French vaccine maker Valneva struck a deal with the U.K. to supply up to 100 million doses of its vaccine candidate, expected to enter clinical trials by the end of the year. The U.K. will help fund clinical studies on Valneva's inactivated whole virus vaccine—which uses the same platform as its FDA-approved Japanese encephalitis shot—and is hammering out funding for a scale-up of Valneva's Scotland manufacturing site. Meanwhile, Valneva is plotting its own investments for the Scottish factory and another plant in Sweden. Story

CanSino Biologics' COVID-19 vaccine spurred strong neutralizing antibody responses—and some side effects—in a phase 2 study (PDF) targeting 508 healthy adults. Patients in both the high- and low-dose cohorts produced COVID-fighting antibodies at day 28 post-vaccination; 72% of patients in the high dose cohort and 74% given the lower dose reported side effects, including fatigue and headache, while 32% on the higher dose developed a fever. With phase 2 safety data under its belt, CanSino now aims to push the low-dose regimen into phase 3. 

Tried-and-true blood thinner heparin could neutralize COVID-19 before it reaches healthy cells, researchers at Rensselaer Polytechnic Institute found. The virus binds tightly to heparin, where it becomes trapped and ultimately degrades, which could make the drug a useful stopgap before a vaccine is approved, the RPI team said. Story

At least seven Indian pharmas are developing a COVID-19 vaccine: Bharat BiotechSerum Institute of India, Zydus Cadila, Panacea Biotec, Indian Immunologicals, Mynvax and Biological E. Hyderabad-based Bharat leads the pack with its candidate Covaxin—pushed into human trials last week. The Serum Institute recently forged a manufacturing deal with AstraZeneca to help turn out 1 billion doses of the British drugmaker's shot, and it also has a live attenuated vaccine, made with U.S. firm Codagenix, in pre-clinical studies. Meanwhile, Zydus aims to wrap clinical trials on its own vaccine hopeful in about seven months. 

Philips' diagnosis and treatment business saw a 9% sales drop in the second quarter of 2020 as COVID-19 drove many hospitals to idle new equipment installations and elective medical procedures—but it's not all bad news for the medtech giant. The company's Connected Care divisions saw a 14% sales increase boosted by demand for ventilators and remote patient monitoring systems, while incoming orders grew 27%. Story

UPDATED: Monday, July 20 at 9:30 a.m. ET

AstraZeneca and the University of Oxford's COVID-19 vaccine candidate spurred a strong immune response in a phase 1 trial that enrolled over 1,000 patients, data published Monday in the Lancet showed. The partners tested a single-dose and two-dose regimen of the recombinant adenovirus shot, with the double dose yielding a stronger immune response, director of Oxford's Jenner Institute Adrian Hill told CNBC. AstraZeneca is revving up manufacturing for the shot ahead of an approval, with plans to make and distribute 2 billion doses of the vaccine. Story

Pfizer and BioNTech's vaccine candidate triggered "strong" T-cell responses in COVID-19 patients, phase 1/2 data showed. 80% of subjects who received the shot had vaccine-induced CD8 T-cell levels—well-above those produced by Moderna's rival mRNA vaccine—and almost 95% of patients had CD4 T-cell responses. Mounting evidence shows that T-cell response could play a role in lasting immunity against the virus; plus, the Pfizer-BioNTech vaccine triggered the response at the 1 mcg dose, compared to Moderna's shot, which yielded "low levels" of T-cells at 100 mcg. Story

Plus, Pfizer and BioNTech forged a deal to supply the U.K. with 30 million doses of the partners' mRNA-based COVID-19 vaccine in 2020 and 2021, pending approval. The drugmakers are on track to launch a phase 2b/3 study this month and aim to seek regulatory review as early as October. With the ultimate goal of 100 million doses manufactured by the end of the year and 1.3 billion by 2021's close, the partners also expressed interest in tapping Gavi, The Vaccine Alliance and CEPI to further hammer out global distribution. Story

GlaxoSmithKline handed over £234 million ($294 million) to partner with CureVac on mRNA treatments for infectious diseases—CureVac's COVID-19 vaccine program excluded. Under the deal, CureVac will take mRNA shots and monoclonal antibodies through preclinical and phase 1 trials before handing work off to GSK. Story

AstraZeneca's shares climbed 2.5% in the U.K. following last week's report that the drugmaker could drop positive news on its coronavirus vaccine trials, possibly by Monday. The British pharma has yet to unveil early trial data on its recombinant adenovirus candidate, but the results were strong enough to push the shot into its third phase of human trials in Brazil late last month. 

NIAID director Anthony Fauci stood by his cautious timeline to have a COVID-19 vaccine candidate ready for deployment by the end of the year or early 2021 in an interview with Medscape, closing with a reminder that "we're gonna get through this." Other key takeaways from the infectious disease expert? Continued use of masks and social distancing is vital; plus, research into monoclonal antibodies could offer a much needed stopgap ahead of a vaccine approval. 

Plus, the FDA approved pool testing—in which multiple patient samples are reviewed at once—to detect COVID-19. The agency gave an emergency OK to Quest Diagnostics's test that allows up to four different swabs to be processed simultaneously; if a single sample yields a positive result, each patient would then receive an individual test. The move aims to speed up delivery of testing results and ease the burden on diagnostic supplies, but experts say it will be most useful in areas where viral spread is low. Story

Small U.K. pharma Synairgen said its inhaled interferon beta protein SNG001 slashed death rates and ventilator use by 79% in a 220-person COVID-19 trial, causing company shares to jump as much as 373% Monday morning. Story

CEO of the Serum Institute of India Adar Poonawalla wants to use the example of COVID-19 to shake up drug pricing and equitable distribution in the Industry, starting with some of the company's established vaccines. In a Politico Interview, Poonawalla stressed the need to dismantle the patent system on vaccines to secure equitable access for the world, adding that he hoped the Institute would have its own shot candidate licensed in the U.S. within the next year. 

Mylan launched its generic form of Gilead Sciences' remdesivir in India Monday, marketed under the name Desrem. The drug is approved to treat COVID-19 in adults and children hospitalized with severe symptoms. Indian drugmakers Cipla and Hetero Drugs have also launched licensed versions of Gilead's antiviral in the country. 

Glenmark Pharmaceuticals is in hot water with India's drug regulator over alleged "false claims" that its Avigan generic FabiFlu is effective in COVID-19 patients with co-morbid conditions like hypertension or diabetes. Glenmark also took flak for its proposed price for the drug, set at INR 12,500 ($167.04), which the drug regulator blasted as "definitely not in the interest of the poor, lower middle class and middle-class people of India."

UPDATED: Friday, July 17 at 9:00 a.m. ET

The European Union is hashing out advance purchase deals for COVID-19 vaccines with Moderna, Sanofi, Johnson & Johnson, CureVac and BioNTech, two EU sources told Reuters. The news comes on the heels of a deal in June between four European nations and AstraZeneca to secure 400 million doses of the drugmaker's vaccine hopeful. The EU is reportedly furthest along in talks with J&J, already working out dose counts. Meanwhile, Sanofi, with the aid of GlaxoSmithKline, aims to provide the bloc with 300 million doses of its shot in the second half of 2021. 

Plus, Johnson & Johnson is tying up supply deals with Japan and the Bill & Melinda Gates Foundation, which would focus on distributing the shot to developing countries, CFO Joseph Wolk told Reuters. J&J has already locked down U.S. supplies through its funding agreement with BARDA. While none of the new deals has wrapped, they would likely resemble AstraZeneca's recent U.S. supply deal, Wolk said, which saw the British drugmaker net $1.2 billion in government funding for an agreed 300 million doses in the fall. 

China’s Sinopharm kicked off the world’s first phase 3 coronavirus vaccine trial Thursday, dosing an initial patient group in the United Arab Emirates with its inactivated candidate. Partnered with Dubai-based G42 Healthcare and Abu Dhabi Health Services (SEHA), the trial runners plan to recruit a minimum 5,000 patients in the program’s first stage and aim to eventually enroll upwards of 15,000. More than 1,000 Sinopharm staffers, including the company head, have already taken voluntary doses on the strength of phase 1/2 results. Meanwhile, China's Sinovac scored approval earlier this month to run its own phase 3 in Brazil, but that trial hasn't started dosing yet.

Fosun Pharmaceuticals got the thumbs up from China's National Medical Products Administration to run clinical trials on its mRNA-based vaccine candidate. Known as BNT162b, the shot was developed using BioNTech's mRNA technology platform. In March, Fosun obtained the license to exclusively develop and manufacture the COVID-19 vaccine candidate in mainland China, Hong Kong, Macau and Taiwan. The vaccine is currently in a phase 1 trial. 

Researchers at the University of Minnesota further discredited hydroxychloroquine's worth as a COVID-19 treatment in a new trial in patients with early symptoms. Published in the New England Journal of Medicine, the data show death rates of 0.4% were identical among hydroxychloroquine patients and placebo patients. Hospitalizations and persistent symptoms were slightly higher in the placebo group, but not to a statistically meaningful degree. Meanwhile, 43% of hydroxychloroquine patients reported mild side effects compared with the control group's 22%. 

On Thursday, the U.S. recorded more than 75,600 new coronavirus cases, shattering its single-day record, the New York Times reported. This marks the eleventh new record over the past month, and deaths are on the rise, too. Florida reported 156 COVID-related deaths Thursday—its highest total so far—joining a list of nine other states that tallied record fatalities this week, including Alabama, Arizona, Texas and Oregon.  

Most people are well aware of the benefits of hand sanitizer these daysbut are they using it correctly? The FDA hopes to answer that question with a new quiz on proper technique. Sample topics include whether people ought to home brew their own sanitizer, what to do if a child ingests it and how to curb the virus' spread via disinfection.

UPDATED: Thursday, July 16 at 3:00 p.m. ET

Chief of the U.S.' Warp Speed vaccine program and former GlaxoSmithKline exec Moncef Slaoui won't have to disclose outside positions, stock holdings and other potential conflicts of interest after the HHS announced that he would remain a government contractor. Under the current deal, Slaoui is paid $1, but his post exempts him from federal disclosure rules and allows him to maintain his pharma investments. Watchdogs Public Citizen and Lower Drug Prices Now called for Slaoui to be listed as a "special government employee" in May, warning that he could use his influence over the federal vaccine program to "enrich himself, his colleagues and his employers."

Executives and directors from Moderna have sold about $171 million in shares since the start of the year, CNBC reported, far outstripping other companies involved in researching COVID-19 drugs and vaccines. 

Beijing is supplying doses of two COVID-19 vaccine candidates to staffers at state-owned companies and the armed forces ahead of full trial results, the New York Times reported. Employees at oil giant PetroChina were enticed with a government-backed offer for "emergency use" of one of two Sinopharm-made vaccines ahead of overseas travel, without any warning about side effects or the shots' efficacy, the paper said. Certain PetroChina employees and other Chinese pharmas blasted the move, warning that it could stall scientific progress and incite political backlash. 

Adimab spinout Adagio scored $50 million from Polaris Partners, Mithril Capital, Fidelity and more to support development of monoclonal antibodies that it thinks could treat and prevent COVID-19—and other coronaviruses, too. Adagio's antibodies bind to a part of the spike protein found on SARS-CoV-2—responsible for the current pandemic—as well as the virus that causes severe acute respiratory syndrome (SARS), plus two other coronaviruses circulating in bats. The company aims to get its antibodies into the clinic by year end. Story

Small molecule maker Nocion Therapeutics pitted its leading chronic cough program against COVID-19, adapting a planned phase 1 study to tackle viral and postviral cough, too. Unlike other cough treatments designed to target specific receptors, Nocion's platform aims for the neurons that send pain and itch signals when inflamed, giving it an edge in cutting cough more broadly. The treatment could ease both the "traumatic and debilitating" symptom in patients and potentially curb the virus' spread, Nocion thinks. The drug has won priority status as a potential COVID-19 treatment in the U.K. and a phase 1 study is imminent. Story

The number of clinical trials stalled by COVID-19 fell between June and July, GlobalData found, with the greatest uptick in continued disruptions falling on trials that suspended enrollment altogether at 17.3%. Trials with delayed initiation recovered 10%, while those hit by slow enrollment climbed 13.9%. Availability of trial sites and investigators were largely to blame for those delayed enrollment stats, GlobalData said. Story

Last month, U.S. care coordinator CarePort Health revealed that only 3% of COVID-19 patients were taking dexamethasone across its client hospitals and care centers despite the drug's buzz. So how have those stats shaken out in July? As of last week, 41% of patients were being treated with the low-cost steroid. Meanwhile, Gilead's remdesivir saw a 15% spike in late June, but usage of the antiviral slipped to 4.8% last week, possibly due to reported low supply in U.S. hospitals, CarePort CEO Lissy Hu told FiercePharma. Use of once-hyped hydroxychloroquine leveled out at a 1%. 

UPDATED: Thursday, July 16 at 9:40 a.m. ET

Johnson & Johnson will push its vaccine candidate into phase 1/2a in Belgium next Wednesday, with trials in the U.S. to kick off the following week, executives said in a second quarter earnings call. J&J will test a single dose and booster dose in the upcoming trials, with plans to launch a separate phase 2 study in the Netherlands, Spain and Germany. A phase 3 trial could launch ahead of schedule, "potentially in late September," the company said. Story

Hackers linked to Russia's government are targeting vaccine research labs in the U.S., U.K. and Canada, officials said, looking to steal R&D secrets. The U.S. National Security Agency said APT29, a hacking group known as Cozy Bear, has been using spear-phishing and malware to try to get access to the research, the New York Times reports. Cozy Bear is associated with Russian intelligence, the newspaper said. Story

With phase 1 data on Moderna's mRNA vaccine candidate now available, UBS analyst Navin Jacob thinks Pfizer and BioNTech's rival mRNA shot could still be competitive: While Moderna's shot proved most effective at the 100mcg dose, BioNTech's vaccine performed well at 10-35% of that dose. Paired with Pfizer's vaccine manufacturing brawn, the partners' shot has a better chance at meeting global demand, Jacob figures. 

Novartis' Sandoz division will deploy a suite of 15 generics at no profit to 79 countries on the World Bank's list of low- and lower-middle income nations to treat patients with COVID-19 symptoms. Those meds include antibiotics, the heart failure drug dobutamine, the steroid dexamethasone—which has shown success treating COVID-19—and more. Story

Russia aims to churn out 30 million doses of an experimental COVID-19 vaccine in-country before the year is out, and could manufacture another 170 million abroad, a top government official told Reuters. Developed by Moscow’s Gamaleya Institute, the shot's 100-person phase 2 study is set to wrap early next month, and Russia is eyeing an August start for a phase 3 trial. It could score approval by next month, the official said. 

India's pharma industry could manufacture enough COVID-19 vaccines not just for itself but the entire world, Microsoft co-founder Bill Gates said Wednesday—with the added caveat that the country's size and population density pose unique COVID-19 risks. The Bill & Melinda Gates Foundation, which has also launched the COVID-19 Therapeutics Accelerator initiative, has partnered with the Indian government, funding work on detection of the virus and quarantine measures for infected patients. 

In interviews with The Atlantic, NIAID director Anthony Fauci stood strong against recent efforts by the Trump administration to tarnish his rep and question his judgment. Fauci said the "bizarre" attempts to discredit him were clearly a mistake and questioned the timing as cases continue to flare in certain U.S. regions. 

Academic hospitals on the frontlines of COVID-19 treatment in the U.S. and Italy are prepping excess ICU capacity for a predicted resurgence this fall, two expert physicians said at SVB Leerink's annual Therapeutics Day event. The good news? Doctors now understand COVID-19 risk factors and have ruled out many ineffective treatments floated early in the pandemic. Both doctors said they're using Gilead's remdesivir and the low-cost steroid dexamethasone, plus convalescent plasma in trial settings. 

UPDATED: Wednesday, July 15 at 3:25 p.m. ET

The FDA's Coronavirus Treatment Acceleration Program (CTAP) is now working with more than 510 drug development programs in the planning stages and, as of Tuesday, has reviewed more than 230 trials for COVID-19 therapeutics, the agency said. Those numbers were revealed in a behind-the-scenes look at CTAP, published by the FDA in an apparent bid for transparency, that breaks down the program's review process, regulatory approval milestones and more. 

Back in April, the Trump administration tapped little-known ApiJect Systems for the company's injector technology—not yet approved by the FDA—to help deliver millions of vaccine doses. The government would pay $138 million to ApiJect for 100 million devices by year's end, along with $456 million to create new factories for 500 million more. The company has so far made about 1,000 prototypes of its needle tech, which uses a soft plastic blister rather than a traditional glass vial, and has yet to set up a factory for manufacturing, the AP reports.

China's AIM Vaccines is shelling out CNY 550 million ($79 million) to build a manufacturing and R&D base for its COVID-19 vaccines, with plans to launch the site next March and kick-start production in the first half of 2021. Its subsidiary Rongan Biological will produce inactivated vaccine hopefuls at the new plant, the company said. Also, AIM snapped up a nanoparticle shot candidate in April and said at the time an animal trial was on the way. It's unclear how advanced—or not—either vaccine candidate is. Story

Nephron Pharmaceuticals will invest $215.8 million to scale up its fill-finish capacity and warehousing space to help churn out shots ahead of a COVID-19 vaccine approval. The South Carolina-based company is already in talks with two "large pharmas" to tap its new vaccine capacity, which could come online by the first quarter of 2021, CEO Lou Kennedy said. While the company will likely miss out on the first round of vaccine production, Nephron hopes it can chip in further down the line. Story

After 18 employees at a plant in Gujarat, India, tested positive for coronavirus infection, Lupin joined a growing list of Indian drugmakers forced to shut down operations over a COVID-19 scare. New infections haven't been traced to any of Lupin's other plants, Reuters reports, and the company is testing those who came into contact with the infected workers. Indian drugmakers Sun Pharma, Abbott Laboratories, Dr. Reddy's and more—all major global suppliers for generics and APIs—have also had to pause work at various sites amid COVID-19 outbreaks this year. Story

Travelers arriving in the New York tri-state area from New Mexico, Ohio, Wisconsin and Minnesota must quarantine for two weeks, Governor Andrew Cuomo said Tuesday, adding to a growing list of states—now 22 strong—from which travelers are required to self-isolate after entering New York, New Jersey or Connecticut. 

UPDATED: Wednesday, July 15 at 9:23 a.m. ET

Moderna's mRNA vaccine candidate triggered "robust" levels of neutralizing antibodies in coronavirus patients, newly published phase 1 data show, but some side effects showed up, too. Forty-five patients were given two injections of the vaccine—at three different dose levels—two weeks apart, with those on the 100 microgram dose yielding the highest antibody count when compared against a control group of 38 people who recovered from the disease. Now, Moderna is ramping up for a 30,000-participant, phase 3 trial later this month, with plans to recruit participants from the U.S. states hardest hit by the virus. Story

Plus, Moderna is already churning out vaccine supplies at risk to deploy those shots as quickly as possible in the event of an emergency use OK or full approval, CEO Stéphane Bancel said. The company aims to produce 500 million to 1 billion doses annually, and it's working to fill out its stores "to be able to able to vaccinate everybody in the U.S.," Bancel said. Story

"Positive news" on AstraZeneca's University of Oxford-partnered COVID-19 vaccine could drop as early as tomorrow, a prominent British journalist said Wednesday. That update could shed light on the recombinant adenovirus vaccine's performance in a phase 1 trial earlier this year; that data was good enough to push the candidate into phase 2/3 in May, but the British drugmaker has yet to unveil the results. Story

French president Emmanuel Macron said Tuesday that France would be among the first in line to receive doses of Sanofi's coronavirus vaccine candidate. The French drugmaker fast-tracked work on its "spike" protein-based shot at the end of June, and plans to enter the vaccine candidate into phase 1/2 testing by September, with a possible approval as early as the first half of 2021, the company said. 

Indian pharma Zydus Cadila dosed the first patients in a phase 1/2 trial of its plasmid-based COVID-19 shot, ZyCoV-D. The shot managed to trigger a strong immune response in animal trials, Zydus said earlier this month, and the drugmaker aims to recruit over 1,000 participants across different sites in the country for its human vaccine trials. 

A $99 million federal investment breathed new life into remdesivir early on in the pandemic, but taxpayers are being repaid with "price gouging," Rep. Lloyd Doggett said in a Wall Street Journal op-ed. Last month, Gilead set its price for remdesivir at $520 per vial, or $3,120 for a five-day course, in a move that the president of cost watchdog group ICER called "responsible." While Gilead also revealed a lower price for the full course under certain government programs, Doggett has called that initiative "misleading," as it excludes patients on Medicare, Medicaid, private insurance and those who are uninsured. Story

Cholesterol drug Tricor, known generically as fenofibrate, could thwart COVID-19's ability to reproduce in the lungs, researchers at the Hebrew University of Jerusalem found. In studies on infected human tissue, Tricor was able to swiftly break down accumulated fat in the lungs, which the researchers hypothesize allows the virus to replicate. Now, the researchers hope clinical trials will confirm Ticor's benefit as a long-term treatment option—especially as evidence mounts that antibody immunity may only last for a few months.

Four former CDC heads blasted President Donald Trump via a Washington Post op-ed for undercutting public faith in the agency. Under the current administration, "sound science is being challenged with partisan potshots, sowing confusion and mistrust," said the authors, who together spanned 15 years at the agency under Democrat and Republican presidents. The group also faulted Trump for undercutting CDC guidelines on reopening schools soon after they were released. 

Meanwhile, hospitals will now have to bypass the CDC and send all COVID-19 patient data directly to a Department of Health and Human Services database in Washington, an update on the department's website revealed. Officials say the database will streamline data collection and help the administration's coronavirus task force distribute drugs and supplies like protective gear. While many health experts agree that the CDC's database ought to be centralized, many also worry this new move will hurt transparency and agency access to the data. 

Plus, the FDA ought to hold hearings and publish vaccine data before it grants an approval to boost public faith in the shot, health experts said at Tuesday's House Oversight Subcommittee hearing. Experts pointed to early disinformation linking the measles, mumps and rubella vaccine to autism as a cautionary tale, and highlighted the need for public engagement as vaccine frontrunners plot recruitment for late-stage trials. The FDA's now-backtracked OK for hyrdroxychloroquine, historical harm to Black Americans in vaccine trials, and the general chaos of the pandemic response could further hamper immunization efforts, the experts said. 

UPDATED: Tuesday, July 14 at 3:15 p.m. ET

AstraZeneca teamed up with IQVIA to hustle along U.S. studies of its COVID-19 vaccine candidate, developed with the University of Oxford. The partners will start enrollment for an "expansive subject study" this summer, leveraging IQVIA's virtual trials technology to work around disruptions caused by COVID-19. AstraZeneca has already inked advanced purchase deals with the U.S. and U.K. for shot doses and recently partnered with the Coalition for Epidemic Preparedness Innovations and Gavi, the Vaccine Alliance to hash out vaccine access in low- and middle-income countries. Story

Germany's Merck KGaA, already working with more than 200 groups developing COVID drugs and vaccines, could potentially rake in $4 to $5 billion from its manufacturing services, Jefferies analyst Brandon Couillard said. Merck KGaA's process solutions outfit aims to support companies moving projects from R&D scale to "pilot scale," followed by industrial production. Still, the financial outcome remains uncertain "until we know which vaccines actually work and what type of production processes each will use," Couillard said. Story

3M teamed up with researchers from the Massachusetts Institute of Technology to develop speedy, paper-based COVID-19 diagnostic. The research project has already won $500,000 in initial funding through the NIH diagnostic research competition; if it succeeds, the project will get fast tracked through clinical studies and regulatory review. Plus, the NIH might deliver extra funding, too, toward its goal of providing millions of new COVID-19 diagnostics by the fall. Story

Bioelectric therapy developer electroCore won an emergency OK from the FDA for its handheld nerve stimulation device, gammaCore Sapphire CV, for patients with asthma-related breathing difficulties and those grappling with both asthma and COVID-19. Story

Antibody responses to COVID-19 could start to wane 20-30 days after symptoms emerge, new pre-print data from a U.K. research team showed. Drawing on samples from 65 patients and 31 healthcare workers, the researchers concluded that antibody binding processes declined over time, and severe symptoms were correlated with a longer-lasting antibody response. Though not yet peer-reviewed, the study raises questions about repeat infections and the protective power of vaccines.

FDA scientists pegged specific areas on the SARS-CoV-2 'spike protein' that could trigger a stronger antibody response when targeted by COVID-19 drugs and vaccines. By immunizing rabbits with several antigens that occur at different points along the protein, the researchers found that antibodies triggered by the receptor binding domain (RBD), which the virus uses to bind to the cell, yielded the strongest neutralizing response. The agency thinks its findings could help scientists predict the benefit of spike protein-based vaccine candidates in the works. 

UPDATED: Tuesday, July 14 at 11:10 a.m. ET

British drugmaker AstraZeneca, already at work on a COVID-19 vaccine frontrunner with the University of Oxford, aims to test a dual antibody treatment in 30 patients next month in hopes of providing a vaccine alternative to the elderly and immunocompromised. The antibodies are designed to bind to the virus' spike proteins and prevent it from penetrating the body; AZ says the injection could protect against the virus for up to six months. If the treatment passes muster, AZ plans to follow up with a trial enrolling thousands later this year.

NIAID director Anthony Fauci blamed a lack of strict lockdown measures for the recent surge in U.S. COVID-19 cases during a virtual chat with Stanford Medicine’s Dean Lloyd Minor. But handwashing, social distancing and mask use could still turn things around, Fauci said. Meanwhile, he voiced cautious optimism that a vaccine could be ready late this year or early 2021 and stressed the importance of developing earlier therapies like antibody treatments.

Plus, an anonymous top official from the Trump Administration told Reuters the U.S. is on track to start manufacturing a vaccine in about four to six weeks, with active manufacturing slated to begin in earnest by summer's end. The administration is already working to outfit manufacturing sites and equip them with raw materials, the official said. Story

Meanwhile, Merck & Co. CEO Ken Frazier attempted to curb vaccine expectations in a wide-ranging virtual talk with professor Tsedal Neeley of Harvard Business School, pointing out that there have only been seven truly new vaccines introduced into global clinical practice over the past quarter-century. Frazier added that a vaccine needs to protect everybody, not just some. "I think when people tell the public that there's going to be a vaccine by the end of 2020, they do a grave disservice to the public," Frazier said. Story

Shanghai Fosun Pharmaceutical's mRNA COVID shot, developed with German partner BioNTech, has won the OK from China's National Medical Products Administration to enter clinical testing, the company said Monday. In March, Fosun scored the license from BioNTech to develop and sell its vaccine candidate in China, Hong Kong, Macau and Taiwan—regions excluded from BioNTech's Pfizer team-up. Meanwhile, BioNTech revealed Monday that two of its vaccine candidates, including the candidate licensed to Fosun, scored fast track designation from the FDA.

The number of new patients entering clinical trials jumped 112% in June, clinical trial tech company Medidata found, rebounding from a roughly 70% decline in new enrollments in April. Globally, new patient starts are still down 30% from where they were before the pandemic, but European countries like Italy, France and Spain are bringing their trial activity back up to par. For its part, the U.S. has bounced back 150% from an April low, but as new cases flare up in the country, clinical trials could get derailed yet again, Medidata warned. 

As an essential business, pharma manufacturing is largely immune to lockdown measures in India, but drugmakers are still churning out less supply as they grapple with reduced workforces and travel restrictions due to the pandemic, GlobalData found. The delay in raw materials reaching factories—or not arriving at all—could hamstring global supplies of active pharmaceutical ingredients (APIs), the analytics firm said. Meanwhile, some sites are recovering: A campus in Baddi, Himachal Pradesh that hosts Abbot, Dr. Reddy's and more and accounts for over a third of the country's drug output began reopening in late April. 

UPDATED: Monday, July 13 at 3:15 p.m. ET

Jefferies analysts pegged Moderna's coronavirus vaccine candidate for a likely approval early next year and figure it could rake in billions in sales, too. The analysts predict 50 million people will get the vaccine in 2021 at $50 per dose, netting Moderna about $2 billion in 2021 and $5 billion over the next few years. But if the shot doesn't work, the company's stock would be "hit hard," they warned. Moderna's mRNA-based candidate is slated to enter phase 3 testing this month. Story

The FDA will resume "prioritized" manufacturing inspections in the U.S. next week after a four-month pause on most on-site walkthroughs, Commissioner Stephen Hahn said Friday. But as COVID-19 surges around the country, the agency will pick the sites they inspect based on local and state infection data, and investigators will pre-announce their visits, Hahn said. Meanwhile, foreign drugmakers have pressed the FDA to use alternative inspection methods during the pandemic. Story 

World Health Organization chief Tedros Adhanom Ghebreyesus warned Monday that the world is far from quashing COVID-19, with "too many countries... heading in the wrong direction." Coronavirus infections jumped by 1 million over the past five days, a Reuters tally showed, and while some places have successfully "flattened the curve," others are imposing new rounds of shutdowns. Meanwhile, the U.S., Latin America and more are still seeing massive spikes in their first wave of infections. 

Swiss contract manufacturer Lonza said Monday that it had licensed its gene expression system to China's Junshi Biosciences to produce its neutralizing COVID-19 antibody, JS016, which entered an early-stage safety trial in June. Junshi is co-developing its antibody candidate with Eli Lilly and will head up clinical testing in China while Lilly tackles trial work elsewhere. Warp Speed finalist Moderna tapped Lonza in May for a 10-year manufacturing agreement to churn out doses of its mRNA vaccine candidate. 

The White House took aim at a member of its coronavirus task force this weekend, releasing statements from Anthony Fauci early on in the pandemic that later turned out to be wrong. Tensions ramped up Monday when President Donald Trump retweeted posts further discrediting the NIAID director. Last Friday, Fauci said he hadn't briefed Trump on the outbreak in over two months. 

UPDATED: Monday, July 13 at 9:25 a.m. ET

Pfizer and BioNTech said Monday that two of the partners' four mRNA vaccine candidates won fast track designation from the FDA. Last week, Pfizer CEO Albert Bourla and BioNTech chief Ugur Sahin floated approval timelines for their vaccine in the fall or winter, respectively, following positive early trial data for one of its contenders. Phase 3 testing is slated to start later this month. Story 

Analysts and health officials continued questioning Gilead Sciences' decision to release data on remdesivir Friday that compared clinical trial data with a historical, standard-of-care patient cohort. Former FDA commissioner Scott Gottlieb called the results encouraging but said they "[need] to be confirmed in a prospective trial." Meanwhile, Raymond James analyst Steven Seedhouse said, "The aggregate clinical data still pretty clearly point to an inconclusive impact on survival at best.”

Indian drugmaker Glenmark Pharmaceuticals dropped the price on its Avigan generic FabiFlu to INR 75 ($0.99) per tablet for emergency use in mild-to-moderate COVID-19 patients. Higher manufacturing yields and strong ramp-up led to the discount, Glenmark said. The company also launched a 1,000-patient post-marketing study of coronavirus patients treated with the drug. 

Indian API giant Biocon got the thumbs up from the country's Drugs Controller General (DCGI) to market itolizumab—first approved in 2013 for chronic plaque psoriasis—for emergency use in moderate-to-severe COVID-19 patients fighting cytokine release syndrome (CRS). Biocon will manufacture and formulate the drug for injection at its biomanufacturing site in Bengaluru. 

Meanwhile, Indian newspaper The Hindu argued that Biocon's trial, which pitted 20 patients on itolizumab against 10 on standard of care and yielded no deaths in the drug group compared with three in the control, had not tapped enough patients to make a clear case for the drug.

South Korea's GC Pharma is developing a leading plasma therapy that it hopes can slash death rates in seriously ill COVID patients, but the company is struggling to recruit plasma donors. Out of around 12,000 recovered COVID-19 patients who could donate, 361 had shown interest and only 171 volunteered as of Saturday. To produce enough for 60 patients, the company needs plasma from at least 100 donors, GC said. 

Bill Gates said Saturday that approved COVID-19 vaccines should go to those in need rather than the "highest bidder," citing the 2002 Global Fund to Fight AIDS, Tuberculosis, and Malaria as a model for how to deploy coronavirus shots and treatments equally. The Bill & Melinda Gates Foundation has poured funding into the development of COVID-19 therapies through its COVID-19 Therapeutics Accelerator. 

The FDA added five more products to its list of hand sanitizers—now 59 strong—recalled for containing methanol, a dangerous ingredient found in antifreeze and fuel. The agency added that its investigation into methanol-tainted hand sanitizers was ongoing, and it warned those who have used the recalled products to seek immediate medical attention.

UPDATED: Friday, July 10 at 3:30 p.m. ET

Gilead Sciences released new data Friday showing its antiviral remdesivir slashed death rates by 62% compared with standard treatment, but health experts aren't convinced. Gilead compared 312 patients dosed with remdesivir in its phase 3 SIMPLE trial against a historical cohort of 818 patients with similar disease severity on "standard of care," but because that comparison wasn't performed in a controlled trial, the numbers are "deeply flawed," one expert said. Gilead itself said the findings "[require] confirmation in prospective clinical trials." 

On Friday, Tampa, Florida-based Oragenics called it quits on its candidate aimed at chemo and radiation side effects to go all-in on a COVID-19 vaccine picked up in the company's buyout of Noachis Terra. Next, the company hopes to net funding from the Biomedical Advanced Research and Development Authority (BARDA) and other federal agencies to shore up its newly-unveiled vaccine quest. Story

An Italian study of 143 recovered COVID-19 patients found that the vast majority still suffered from symptoms months later. Assessed about 60 days after their first COVID-19 symptoms arose, 87.4% of patients still reported at least one symptom related to the virus. A majority reported continued fatigue at 53.1%, with breathing difficulty a close second at 43.4%. The results, published in the medical journal JAMA, make a case for continued monitoring of COVID-19 patients post-hospital discharge. 

Britain's decision to opt out of an EU effort to score vaccine doses—reported yesterday via The Telegraph—will not affect ongoing talks with drugmakers, the European Commission said Friday. In June, Reuters reported that European officials were hashing out deals with Johnson & Johnson and Sanofi to lock down doses of their COVID-19 vaccine candidates. 

Medtech company Philips will fold BioIntelliSense’s health-tracking sticker into its remote patient monitoring programs to observe COVID-19 patients—and those hit with other chronic diseases—after they leave the hospital. U.S. service provider Healthcare Highways will be the first to use the BioSticker across seven monitoring programs, which include COVID-19. Story

Boehringer Ingelheim's collaboration with academic researchers to develop COVID-19 treatments has paid off with the discovery of 28 antibodies that could neutralize the virus. A research team headed by Cologne University Hospital and the German Center for Infection Research compared the antibody response to COVID-19 in 12 patients who recovered from the virus to immune cells from 48 healthy people collected before the pandemic, ID'ing antibodies with the strongest neutralizing effect. The research teams predict clinical trials on the top antibody candidates could start by year's end. Story

UPDATED: Friday, July 10 at 9:18 a.m. ET

An FDA green light for Pfizer's mRNA vaccine candidate—developed by German partner BioNTech—could come as early as October, CEO Albert Bourla told TIME. On the heels of positive phase 1/2 results, Pfizer ramped up its projected shot production to 100 million doses by year's end. The company has also launched talks with governments around the globe to mete out supplies, Bourla said. A phase 3 vaccine trial enrolling 30,000 patients is expected to begin later this month.

Meanwhile, BioNTech expects to seek regulatory approval for the messenger RNA shot by the end of the year, CEO Ugur Sahin told the Wall Street Journal. The German biotech expects the upcoming phase 3 study to conclude by late 2020 and regulatory fillings to follow immediately. Sahin stood by the company's goal to churn out hundreds of millions of doses pre-approval, with that number expected to land in the billions by 2021. Story

COVID-19 patients dosed early on with Fujifilm's flu med Avigan in a Japanese clinical trial showed more improvement than those treated after their illness advanced, but the results weren't statistically meaningful, researchers from Fujita Health University said Friday. The drug, known generically as favipiravir, has already been approved for COVID-19 in Russia and India, but Japan has struggled to keep its own studies on track as the country faces a shortage of trial participants. 

The World Health Organization backtracked its assertion that the coronavirus doesn't spread through small, airborne particles. In a letter published this week, two scientists from Australia and the U.S. argued that the virus is released "in microdroplets small enough to remain aloft in the air," and more than 200 experts urged WHO to update its guidance on virus transmission. Now, WHO has conceded that airborne spread, especially in indoor spaces, "cannot be ruled out."

Researchers at Regeneron's Tarrytown, New York headquarters dove into COVID-19 antibody work when the virus first struck in January. Then, in March, the virus touched down on the company's home turf. The drugmaker quickly adjusted, pushing its other projects to a plant in Ireland, staggering shifts and repurposing company cars for staffer commutes. The payoff? Regeneron's much-hyped antibody cocktail now moving into treatment and prevention trials. 

Plus, Novo Nordisk forged ahead with the early 2020 launch of its diabetes med Rybelsus when the outbreak struck. Noting the increased risk for COVID-19 complications in patients with uncontrolled diabetes, Novo paired coronavirus education with its launch strategy. Meanwhile, Novo beefed up its digital presence by holding a virtual speaker series for doctors and launching an online copay system where patients could also ask Rybelsus questions via text.  

UPDATED: Thursday, July 9 at 3:20 p.m. ET

FDA vaccine official Peter Marks thinks eradicating SARS-CoV-2 will take a vaccine that's 70% effective—and received by 70% of the population. Marks' guidance eclipses the FDA's 50% efficacy bar it set last week. In order to make sure the vaccine is truly effective, the FDA is strongly encouraging companies to recruit a diverse group of trial participants, Marks said. He also added that "challenge trials"—in which patients are infected with the virus to accelerate research—weren't completely off the table; the agency would consider such trials "based on protocol" and "given the circumstances," Marks said. Story

Meanwhile, officials from Merck, Moderna, Pfizer, AstraZeneca and Johnson & Johnson plan to testify before the House's Oversight and Investigation Subcommittee on July 21 to discuss their progress on a COVID-19 vaccine. The companies are also expected to share info on upcoming plans to market and distribute those shots should they pass muster in the clinic. 

The University of Oxford and its Oxford Suzhou Centre for Advanced Research in China are launching a new company, dubbed Oxsed Limited, to develop a rapid COVID-19 test with an expected price of no more than £20 ($25). The simplified viral RNA test uses RT-LAMP technology, which requires far less hardware and labor to yield a result than widely-used PCR-based lab tests, making it more desirable for use in the field. Next up, Oxsed Limited will pursue a CE mark as it looks to push the test to market. Story

Plus, the Center for Health Security at Johns Hopkins Bloomberg School of Public Health issued a report Thursday outlining the public's role in COVID-19 vaccination efforts. The center highlighted common anxieties among the public about vaccination safety, affordability and access, along with suggestions on how companies might ease those concerns. Offering vaccines at no cost to all U.S. residents, establishing safe and familiar vaccination sites and forming official communication channels to counter misinformation and increase public ownership over vaccine programs were among the center's chief recommendations. 

UPDATED: Thursday, July 9 at 9:15 a.m. ET

Moderna tapped contract manufacturer Laboratorios Farmacéuticos Rovi to complete fill-finish work on its mRNA vaccine candidate. Rovi will carry out the work at its Madrid, Spain, facility, and plans to ramp up a new production line and buy new equipment to help Moderna meet its goal to churn out hundreds of millions of shot doses for deployment outside of the U.S. by early 2021. Rovi will also recruit additional staff to meet the new manufacturing demand. Story

Plus, Johnson & Johnson CEO Alex Gorsky warned that an approved COVID-19 vaccine would not be a pandemic panacea. Even if multiple candidates are approved by early 2021, proper education and distribution systems will determine whether that shot is deployed successfully. Social distancing, mask-wearing and drug development will remain essential even after a shot is available, Gorsky warned. 

The Centers for Disease Control and Prevention (CDC) and an advisory committee of health experts are patching together a plan for how—and to whom—an eventual COVID shot should be allocated. Under the preliminary plan, medical and national security experts would get first dibs, followed by front-line workers and those at higher risk of infection like the elderly and immunocompromised. Now, the group is weighing whether to provide early access to Black and Latino populations, who've suffered disproportionately from the virus. 

Gilead Sciences dosed the first patients in a phase 1a trial studying an inhaled formulation of remdesivir for early stage COVID-19. The drugmaker aims to recruit about 60 U.S. patients aged 18 to 45 for the trial, which will compare a nebulized version with placebo. Delivering remdesivir straight to the lungs could cut the risk of side effects and expand its use to outpatients, Gilead said; remdesivir is currently given to hospital patients intravenously. Story

Plus, Gilead plans to boost worldwide production of remdesivir to supply the antiviral in Europe based on each country's rate of infection, the company's German managing director Bettina Bauer said. Talks are already underway with the German government, Bauer told German business magazine WirtschaftsWoche. The drugmaker aims to ramp up its monthly supply from 190,000 treatment cycles to 2 million by December, she said. 

Russia OK'd a new COVID-19 antiviral from drugmaker R-Pharm, dubbed Coronavir, after positive performance in a trial of more than 110 outpatients with mid-stage COVID-19. By the fifth day of treatment, the virus had been eliminated in 77.5% of Coronavir patients, R-Pharm said. It's the third drug approved in Russia to treat COVID-19. 

UPDATED: Wednesday, July 8 at 3:20 p.m. ET

The Coalition for Epidemic Preparedness Innovations (CEPI) expanded an earlier deal with China-based Clover Biopharmaceuticals in a bid to hustle Clover's S-Trimer COVID-19 vaccine candidate into clinical testing. In April, CEPI invested $3.5 million to help Clover prep for phase 1, and now it will shell out $66 million more to speed Clover's shot into preclinical and phase 1 studies, and help the company scale up manufacturing.

Lyon, France-based biotech Osivax snapped up €30 million ($33.8 million) from the European Innovation Council (EIC) and Bpifrance to develop its universal coronavirus and influenza vaccines. Osivax's flu shot is designed to help the immune system recognize a conserved part of the influenza virus, rather than its mutation-prone surface antigens, and the company is pivoting that same tech to target SARS-CoV-2—the virus behind the current COVID-19 pandemic—plus future coronavirus strains. Story

Amgen could pit Enbrel—or another drug from its anti-TNF portfolio—against COVID-19, CEO Robert Bradway hinted during Fortune's Brainstorm Health virtual conference. Other anti-inflammatories like Roche's Actemra and Novartis' Ilaris are already in clinical trials to curb potentially fatal immune reactions in COVID patients; meanwhile, Regeneron and Sanofi axed a trial studying their IL-6 inhibitor Kevzara in ventilated COVID patients earlier this week. Amgen has also ramped up trials for its psoriasis drug Otezla to prevent respiratory distress in COVID patients. Story

Indian drugmaker Cipla has deployed its version of remdesivir in the country, setting the sticker price at INR 4,000 per 100mg vial, or about $53.38—one of the lowest prices globally. For comparison, Mylan has capped its generic form of the drug at INR 4,800 ($64.05) per 100mg vial, while Hetero set a maximum retail price of INR 5,400 ($72.06). Cipla aims to dispense 80,000 vials in the first month, and will make them available through government and hospital channels, CEO Nikhil Chopra said. 

The National Institute of Allergy and Infectious Diseases (NIAID) started a new clinical trials network, aiming to enroll thousands of volunteers in large-scale, phase 3 studies of COVID-19 vaccines and antibody treatments. The new COVID-19 Prevention Trials Network (COVPN) is expected to conduct its first phase 3 trial on Moderna's mRNA vaccine candidate, which could start as early as this summer, the NIH said. Story

Medical device maker BD scored an emergency OK from the FDA for a portable coronavirus antigen test designed to turn out results in about 15 minutes. In clinical studies, the diagnostic correctly ID'd 84% of positive COVID-19 samples and yielded no false negatives. BD aims to produce 10 million coronavirus tests through September, with 2 million per week after that. Story

With a recent cash infusion from BARDA and the U.S. Department of Defense—and amid worries about shortages of glass vials for COVID-19 treatments and vaccines—drug packaging company SiO2 Materials Science will invest $163 million to upgrade its Auburn, Alabama, vial plant. Story 

An FDA report found that at least 87 people died from taking hydroxychloroquine and chloroquine between December and May 6. The agency pored over 380 hydroxychloroquine safety reports as part of its review, 28% of them from the U.S. Earlier this week, President Donald Trump touted the drug for COVID-19—again—despite the FDA's decision to pull its emergency authorization. 

Plus, Brazilian President Jair Bolsonaro, who confirmed yesterday that he had tested positive for COVID-19, said he was taking hydroxychloroquine, adding that the once-hyped antimalarial made him feel "a lot better." Bolsonaro has faced criticism for downplaying the severity of the virus as it rages across Brazil, second only to the U.S. in COVID-19 deaths.   

UPDATED: Wednesday, July 8 at 9:00 a.m. ET

The European Commission inked deals with Roche and German drugmaker Merck KGaA to secure doses of those companies' experimental COVID-19 treatments for any of the 27 EU nations willing to buy, Reuters reported. Roche will supply its arthritis med Actemra, also known as RoActemra, while Merck is offering up its multiple sclerosis med Rebif. Both drugs have anti-inflammatory properties and may help curb cytokine storm in severely ill COVID patients. 

Meanwhile, Actemra and remdesivir have hit the black market in Delhiwith exorbitant price tags to match, a BBC investigation found. Patients searching for remdesivir, which Indian doctors can prescribe on compassionate grounds, report that the drug is almost impossible to find in pharmacies. So far, Hetero is the only Indian firm producing Gilead's antiviral in the country. Meanwhile, Cipla, which sells Actemra in India, pointed to supply difficulties surrounding that import-only drug. 

And Cipla announced that its version of remdesivir is slated to hit Indian markets in the next few days. Cipla partnered with Mumbai-based BDR Pharma to manufacture the drug, which in turn sub-contracted Sovereign Pharma to complete fill-finish work. The partners haven't said how much they plan to ship, but Sovereign said it can scale up to 95,000 vials per month.

Bristol Myers Squibb CEO Giovanni Caforio and Novartis chief Vas Narasimhan touted industry collaboration amid the pandemic at Fortune's virtual Brainstorm Health Conference. Open sharing of research, access to pharma companies' drug formulas and regular R&D chief meetings have helped the industry pivot to tackle the virus as a team, the CEOs said. Eyeing the next possible pandemic, Narasimhan advocated for global surveillance of hotspots where known viruses can infect humans. Meanwhile, Caforio thinks this newfound industry collaboration could tackle other diseases like cancer. 

Medical experts condemned the "desperation science" that they say has colored COVID-19 treatment and vaccine research. Faced with a pandemic, many researchers have cut corners, making traditional clinical research look slow, and the public has undermined some legitimate R&D by getting its hands on unproven treatments like hydroyxychloroquine.  “Everyone has been kind of grasping for anything that might work. And that’s not how you develop sound medical practice,” said frequent FDA adviser Dr. Steven Nissen. "Desperation is not a strategy."

And even as the Trump Administration has vowed to crack drown on price surges during the pandemic, pharmaceutical companies logged more than 800 drug price increases this year, data from GoodRx found. In July alone, companies hiked the price of 42 meds by an average of 3.3%. Non-COVID related respiratory treatments Bevespi Aerosphere, Daliresp and Tyvaso are among those with boosted prices, and AstraZeneca raised the cost of its heartburn drug Nexium by 6%. Critics have blasted the industry for sticking to its "price-hiking playbook" amid the pandemic. 

The Marriott Long Wharf hotel, which in late February hosted the now-infamous Biogen leadership conference that resulted in at least 100 known COVID-19 infections in Massachusetts, reopened Tuesday

UPDATED: Tuesday, July 7 at 3:10 p.m. ET

Johnson & Johnson has updated its pact with New Jersey-based Catalent for undisclosed finishing work at the CDMO's Anagni, Italy, facility. Catalent was recently tapped by British drugmaker AstraZeneca for fill-finish work on its Oxford-partnered COVID-19 vaccine at that same plant, and in April, Catalent signed an initial deal with J&J to reserve fill-finish capacity for its COVID-19 shot at the CDMO's Bloomington, Indiana, site. Story 

Moderna's shares dropped 5% last week when news surfaced that it might delay the launch of its phase 3 vaccine trial due to protocol changes. Now, some of those potential hiccups have come to light: Moderna sparred with government experts over how to run its trial, sought a lower bar for approval than the 50% efficacy rate outlined by the FDA, and submitted trial protocols late, three sources close to the vaccine project told Reuters. Moderna has dismissed the snags as "differences of opinion." Story

GlaxoSmithKline added Medicago to it's growing list of COVID vaccine partners as it looks to combine its pandemic adjuvant system with Medicago's recombinant coronavirus virus-like particles (CoVLP). CoVLPs mimic the virus' structure, allowing them to be ID'd by the immune system; pairing that approach with an adjuvant "may boost the immune response and reduce the amount of antigen required per dose," GSK said. A phase 1 study is expected to launch in the next week or so, and the partners said they aim to make the vaccine available by the first half of 2021. Story

Testing giant LabCorp launched a new, at-home COVID-19 test collection service to help doctors screen patients for the disease before surgeries and treatments. The service will allow doctors to order at-home tests for patients through LabCorp, which patients will FedEx back to the company. LabCorp will then upload patients' results to their healthcare providers' electronic medical records. The service scored an emergency OK from the FDA on July 1 and will launch with select providers before a broader rollout in hospitals and surgical centers, LabCorp said. 

German vaccine maker CureVac nabbed a nearly $85 million loan from the EU to scale up manufacturing at its Tübingen, Germany, facility for its mRNA-based COVID shot. The loan, financed by the European Investment Bank, is set to pay out in three $28.3 million increments upon CureVac's completion of preset milestones, the company said. CureVac will use the extra funds to upgrade its current mRNA production suites and build a fourth facility at the Tübingen site. Story

The Serum Institute of India aims to develop a COVID-19 vaccine by the year's end, CEO Adar Poonawalla said during the launch of a compact diagnostics machine by MyLab Discovery Solutions. The Serum Institute has also invested over 1 billion Indian Rupees ($13.4 million) in the Pune-based molecular diagnostics firm in a bid to increase Indian testing capacity. Poonawalla added that the Serum Institute would take its time to produce a vaccine, with more news on that front expected about six months from now. 

Public perception of the industry has improved during the pandemic, and a new study from Novartis showed that 73% of tech professionals have warmed up to pharma as it responds to COVID-19, too—well above the general public's 40% rise in opinion found by the Harris Poll. Now, Novartis chief digital officer Bertrand Bodson thinks that shift could attract sought-after tech talent to pharmaceutical companies and expand tech training options for current staffers. Story

President of Brazil Jair Bolsonaro, who has repeatedly taken flak for downplaying the severity of the virus that has infected more than 1.6 million in the country and killed over 65,000 Brazilians, confirmed Tuesday that he had tested positive for COVID-19. The president said that the took a coronavirus test Monday after he was hit with fever and fatigue, but added that he was feeling well, which he attributed to having taken hydroxychloroquine—a drug that has shown no benefit in trials. 

Meanwhile, president Donald Trump took to Twitter to voice support—again—for failed COVID-19 treatment hydroxychloroquine Monday. White House adviser Peter Navarro doubled down Tuesday morning, telling CNN, "Give peace a chance and give hydroxy a chance, it can save lives." In mid-June, the FDA axed its emergency use authorization for the drug in COVID-19 patients, followed by a warning on July 1 that use of the drug outside hospitals and clinical trials could pose serious health risks. 

UPDATED: Tuesday, July 7 at 9:09 a.m. ET

Beijing-based Sinovac Biotech scored approval from Brazil's regulatory agency, Anvisa, to launch a phase 3 trial of its inactivated COVID-19 vaccine in the country. Anvisa fast-tracked the application for the trial, which will run in partnership with Brazilian vaccine maker the Instituto Butantan and aims to recruit nearly 9,000 healthcare workers from COVID-19 specialized facilities. Enrollment is slated to start this month. 

Plus, Novavax was selected for the Trump Administration's Operation Warp Speed after all. The company said Tuesday that it had scored $1.6 billion from the program to rapidly scale up production and launch late-stage human studies of its COVID-19 vaccine candidate, which uses an antigen generated from the virus' spike protein plus Novavax's Matrix-M adjuvant. Novavax now plans to launch phase 3 trials on up to 30,000 patients starting in the fall and pledges to deliver 100 million doses of its shot as early as the end of the year should it succeed in the clinic. Story

Regeneron inked a $450 million manufacturing and supply contract with the Biomedical Advanced Research and Development Authority (BARDA) and the U.S. Department of Defense to churn out doses of its COVID-19 antibody cocktail, REGN-COV2. The funding comes as part of the Operation Warp Speed program to accelerate development of coronavirus treatments and vaccines. Yesterday, the company said it would move its antibody duo into the next phase of human studies and launched an additional phase 3 prevention trial. Story

EU Health Commissioner Stella Kyriakides, along with other health officials, held talks with Gilead Sciences Monday to hash out remdesivir supplies for 16 European countries, including Germany, Belgium, and the Netherlands, an unnamed source close to the talks said. The European Commission confirmed that talks were taking place at a technical level, but provided no further detail. The move comes as governments and health experts blasted the U.S. for buying much of Gilead's remdesivir supply through September. Story

UPDATED: Monday, July 6 at 3:12 p.m. ET

Johnson & Johnson inked a five-year work order with Maryland-based CDMO Emergent BioSolutions—worth an initial $480 million—to help churn out doses of its COVID-19 vaccine candidate. Emergent will provide "large scale" drug substance manufacturing for two years starting in 2021; for the final three years, the partners will adjust to supply annual batches as needed. Back in June, Emergent penned an $87 million deal with AstraZeneca to help the British drugmaker turn out more than 2 billion doses per year of its Oxford-partnered shot by 2021. Story

Plus, Warp Speed finalist Moderna took a 5% hit to its shares last Thursday after an anonymous investigator told healthcare publication Stat that the company would delay starting its phase 3 vaccine trial. Moderna quickly took to Twitter to maintain that its mRNA vaccine hopeful was still on track to start testing this month. Story

Sanofi and Regeneron nixed U.S. studies of rheumatoid arthritis med Kevzara in ventilated COVID-19 patients after the drug failed to slash death rates or move patients off ventilators in a phase 3 trial. On top of that, 80% of patients given the 400mg dose of Kevzara showed side effects compared with 77% in the standard-of-care control group, and 3% suffered severe side effects like multi-organ dysfunction and low blood pressure. A Kevzara study outside the U.S. will barrel ahead nonetheless. Story

Indian drugmaker Zydus Cadila said it got the thumbs up to run phase 2b trials on its investigational drug desidustat—previously pitted against anemia and kidney disease—in COVID-19 patients in Mexico. Working with one of Mexico's leading contract research organizations, the Avant Santé Research Center, Zydus will dose patients with 100mg tablets of desidustat over a 14-day period in hopes that the drug will treat signs of hypoxia that lead to organ failure and death in COVID patients. 

And with flu season looming as COVID-19 rages on in the U.S., the FDA issued an emergency OK to the CDC for a combination influenza/COVID-19 diagnostic test. The CDC's new multiplexed assay will distinguish between patients with one of the two diseases, who may present similar symptoms, in a move that aims to expedite American testing results and ease the strain on diagnostic supplies, FDA commissioner Stephen Hahn said. Story

And 239 scientists in 32 countries are calling on the World Health Organization to update its guidance on the virus' spread. An open letter to the agency—slated for publication next week—argues the coronavirus can spread through small, airborne particles, not just droplets, the New York Times reported. The WHO has pushed back, stating that airborne transmission is "possible but certainly not supported by solid or even clear evidence."

Digital outreach has become the new norm for pharmaceutical companies in China, top execs from WPP Health told Fierce Pharma, and the benefits of those virtual tools could have a huge impact on healthcare providers and patients long after the pandemic subsides. Beyond the industry, patient access in China—a longtime dilemma for country's huge population—has improved with the novel use of messenger apps like WeChat, WPP Health's executive vice president of market access Yi Han said. Story

UPDATED: Monday, July 6 at 9:00 a.m. ET

Regeneron's dual antibody cocktail REGN-COV2 will move into phase 2/3 trials to both treat and prevent COVID-19. Slated to take place at around 100 sites, the phase 3 prevention trial will test the cocktail against infection rates in an expected 2,000 U.S. patients. Phase 2 treatment trials will focus on hospitalized and non-hospitalized patients in the U.S., Brazil, Mexico and Chile. Preliminary data are expected over the summer, Regeneron said. Story

In the wake of a similar agreement with AstraZeneca and Oxford University, the U.K. government is closing in on a £500 million ($625 million) deal with Sanofi and GlaxoSmithKline to secure 60 million doses of the partners' coronavirus vaccine candidate, sources near the deal told The Sunday Times. Human trials on the GSK-Sanofi shot aren't expected to start before September, but the U.K., heavily reliant on vaccine imports, has worked to lock down supplies ahead of a COVID shot approval. Story 

Mylan won approval from India's drug regulator for restricted use of its licensed version of remdesivir in hospitalized children and adults with severe COVID-19 symptoms. The drug's price will be INR 4,800 ($64.31), about 80% less than the sticker price Gilead Sciences unveiled last week; Mylan's license is for lower-cost versions of remdesivir in developing countries.

The European Commission granted a conditional OK for Gilead's remdesivir to treat COVID-19 patients 12 years and older with pneumonia requiring oxygen support. The conditional approval is good for one year, but the commission may extend it if the drug shows promise in trials testing it in younger patients and in earlier stages of the disease.

Taking a cue from interim trial results that showed the drugs did little to lower death rates, the WHO axed trial arms studying the discredited drug hydroxychloroquine and the HIV med Kaletra—sold by AbbVie—in hospitalized COVID-19 patients. Current studies of the drugs in non-hospitalized patients won't be affected, the agency said.

FDA commissioner Stephen Hahn refused to make a prediction about the current vaccine timeline Sunday, on the heels of a Fourth of July address in which President Donald Trump claimed that unleashed U.S. "scientific brilliance" would see a shot delivered well before year's end. The FDA will weigh safety and efficacy in deciding whether to approve a given shot, Hahn told ABC. Agency officials last week said vaccines must prove at least 50% effective to win final approval.

Former FDA chief Scott Gottlieb urged the U.S. to build up reserves of antibody treatments as promising candidates from AstraZeneca, Eli Lilly, Regeneron and more approach approval to treat COVID-19. "The government should be working with companies ahead of time," Gottlieb told CBS, adding, "We missed the window to do it on remdesivir." 

Meanwhile, the U.S. is sending stores of recently stockpiled remdesivir to hard-hit states like Arizona, Texas and Florida, where new COVID-19 cases have surged, Hahn said. The U.S. faced criticism last week for snapping up 90% of Gilead's remdesivir supply for August and September. 

Plus, AstraZeneca staffers were struggling to balance home-life with at-home work during lockdown. The British drugmaker's solution? Recruit more than 80 teachers to run online classes for employees' children. 

UPDATED: Thursday, July 2 at 9:00 a.m. ET

Officials and health experts around the world lambasted the U.S.' move to snap up most of Gilead Sciences' remdesivir supply. The company says it's working up new doses "as quickly as possible" but noted that the U.S. is seeing a surge of cases, while the spread has moderated elsewhere. The U.K. and Germany told Reuters they have enough on hand for now. Still, the EU wants its own supply, and officials there said they're in talks with Gilead Sciences to arrange just that.

Tesla is building mobile molecular printers to help make an mRNA vaccine in development at CureVac. The machines—which Tesla CEO Elon Musk called "RNA microfactories"—would ship to remote locations and produce CureVac's coronavirus vaccine on-site. For now, though, CureVac has approved manufacturing facilities in Germany where it can turn out hundreds of millions of doses.

Quest and LabCorp are warning that skyrocketing demand for COVID-19 tests is straining their capacity. Quest can perform about 770,000 tests per week, but orders grew by about 50% over the past three weeks, and turnaround time is now 3 to 5 days for patients outside hospitals. It's ramping up to 150,000 tests a day, the company told ABC News. Meanwhile, LabCorp said its turnaround time is delayed even as it expands capacity as quickly as possible.

As the U.S. passed 50,000 daily cases for the first time Wednesday, former FDA chief Scott Gottlieb, M.D., warned the true number is likely 400,000 to 500,000—and the U.S. just doesn't have the testing capacity to identify all of them. "[P]robably 200,000-300,000 are symptomatic," Gottlieb told CNBC. Gottlieb's remarks follow a warning from National Institute of Allergy and Infectious Diseases Director Anthony Fauci, M.D., that daily case counts could hit 100,000. "[W]e're well more than 100,000 cases a day right now," Gottlieb said.

Eusa Pharma, which usually focuses on rare diseases and cancer, won FDA approval to run a phase 3 trial testing its drug Sylvant against COVID-19. The trial would add Sylvant (siltuximab) to standard of care in hospitalized patients in respiratory distress. It's not Sylvant's only coronavirus foray, but this 400-patient trial is "vital," the company said, because well-controlled data are currently lacking. Sylvant is one of several IL-6 inhibitors tackling the potentially deadly lung inflammation that hits severely ill COVID-19 patients.

Another study suggested that HIV drugs—specifically AbbVie's combo med Kaletra—aren't likely to be useful for COVID-19 patients. This time, researchers did a deep dive into existing studies, so the results aren't as persuasive as a clinical trial would be. But their conclusions match up with Recovery trial data reported in the U.K. earlier this week.

UPDATED: Wednesday, July 1 at 3:30 p.m. ET

One of Pfizer and BioNTech's four mRNA vaccine candidates successfully boosted antibody levels in COVID-19 patients, early phase 1/2 data show. In the 45-patient trial, participants dosed with 10 mcg and 30 mcg of the shot generated antibody levels 1.8 and 2.8 times higher, respectively, than the average in a group of patients with confirmed infections. With four vaccine hopefuls in the can, Pfizer and BioNTech are reviewing shot data as they gear up for phase 3 trials that could begin as early as this month. Story

Despite the FDA's Monday guidance that a COVID-19 vaccine would need to prove 50% effective for approval, the means to secure emergency use authorization (EUA) "remain vague," analytics firm GlobalData says. Other analysts have warned political pressure could drive those decisions, even as the agency makes a bid for transparency. And in parsing Monday's guidance, Jefferies analyst Michael Yee said an EUA is the "likely scenario" for early vaccine rollout. Story 

Researchers from Columbia University and the University of Wisconsin-Madison pinpointed five FDA-approved antivirals with COVID-19-fighting potential. Those drugs, which come from Roche, Gilead Sciences, Bristol Myers Squibb and more, can shut down the polymerase protein reaction that drives growth and spread of the virus in the body. Next, the researchers will conduct cell-culture studies to determine the most potent of the five for further testing. Story

Nearly 200 companies have stalled or stopped clinical trials during the pandemic, and suspended enrollment is largely to blame, GlobalData found, citing a whopping 67.3% of trials disrupted for that reason. The analytics firm said that the majority of disrupted trials were in phase 2, with cancer studies hit especially hard. Story  

Synthetic DNA maker Twist Bioscience launched a new research panel to identify respiratory diseases, including the novel coronavirus, using next-generation sequencing that can also detect rhinoviruses, flu strains and more. While not a COVID diagnostic itself, the research panel could catch early signs of outbreak, transmission and viral evolution, Twist CEO Emily Leproust, Ph.D., said. Story 

Meanwhile, LabCorp's contract research organization Covance revamped its Xcellerate platform to help get disrupted trials back on track. Designed in partnership with Covance's COVID-19 Operational Recovery Team, the platform will use real-time data and analytics to identify disruptions as they happen, such as large numbers of patients dropping out of a trial, so that Covance can attempt to right the course. Story

UPDATED: Wednesday, July 1 at 9:30 a.m. ET

Japan's Fujifilm Holdings forged a deal with Indian pharma Dr. Reddy's Laboratories and Dubai-based Global Response Aid to sell its flu med Avigan for COVID-19 treatment in countries worldwide, excluding China, Russia and Japan. Dr. Reddy's also signed on to run clinical trials of the med in India. Meanwhile, Japan has touted Avigan's potential against the virus, but shortfalls in trial enrollment there have slowed its journey to approval. Story

The China National Biotec Group—an arm of the country's state-owned Sinopharm—on Wednesday finished construction of a new coronavirus vaccine plant in Wuhan, doubling that site's capacity to more than 200 million doses a year. The extra manufacturing brawn will aid Sinopharm as it preps its dual COVID shot candidates to enter large-scale phase 3 trials in the United Arab Emirates later this year. 

In a move condemned for putting "America first" amid the pandemic, the U.S. has reportedly bought out Gilead Sciences' entire remdesivir supply for July, and the lion's share for the next two months, too. The initial 140,000 doses Gilead provided for global COVID-19 trials are tapped out, the drugmaker said. Now, the Trump administration has called dibs on the its next 500,000 doses, shutting out other countries for at least the next three months. 

Plus, Novartis CEO Vas Narasimhan sat down with Wired to talk vaccines, pricing and drug launches during a pandemic. Among Narasimhan's pearls of wisdom? Big Pharmas will continue to rely on digital tools as the industry relearns business-as-usual in the era of social distancing. Meanwhile, Narasimhan also touted the importance of cutting drug hype with solid clinical evidence—especially as politicians make sweeping claims about certain drugs' benefits—and said the U.S. would need to campaign against vaccine doubt ahead of a final shot. 

And while the FDA has approved more than 30 new medicines since January, drugmakers Bristol Myers Squibb, Sanofi, Endo Pharmaceuticals and more have had to change their launch plans in response to the pandemic, with additional delays on the horizon, Reuters reports. Companies' top lines could take a hit from those delayed launches, but more worrisome are the patients left without treatment options for less-acute diseases; a peanut allergy med from Aimmune and Neurocrine's Parkinson's drug Ongentys are among those delayed. 

At the start of the pandemic, GlobalData noted sales bumps for some drugmakers in the year's first quarter as people stockpiled medications. Now, the firm has released updated figures showing pharma companies with COVID-19 treatments in their pipelines only grew sales by 3% in the first quarter, compared with 8% growth among pharmas with more diverse drug offerings. Companies pinning their hopes on a single COVID-19 treatment going to market are taking a big gamble, a GlobalData analyst warned. 

UPDATED: Tuesday, June 30 at 4:00 p.m. ET

Gene and cell therapies are are branching out into the world of viruses, and biopharmas like Celularity and AlloVir have pivoted to tackle COVID-19, too. Celularity has managed to turn cancer-fighting natural killer cells against the novel coronavirus, while AlloVir is looking to use its off-the-shelf T cell treatments against the disease. But those companies will have a long road ahead of them to prove their products are at least as safe as more common treatments, like antivirals—and worth the extra cost. Story

Citing huge inconsistencies in reported COVID-19 data, MIT researchers put together their own epidemiological model to trace the virus' spread. Armed with case counts, death tolls and other data from 84 countries, the researchers pegged the true global case count at around 88.5 million, or 11.8 times the official tally, with an estimated 600,000 deaths. Now, the research team says the time for preventative testing has passed: The virus' future spread will depend on government and community willingness to do what it takes to halt transmission. 

Plus, MIT Press will launch a new journal that reviews early versions of coronavirus-related studies known as preprints. The move comes as concerns mount over the large volume of data going public without peer review. The journal will rely on artificial intelligence developed at Lawrence Berkeley National Laboratory to categorize preprints by discipline and novelty, and an in-person team of around 100 will scan those most in need of review. The first set are slated for publication in mid-July.

At a Senate hearing Tuesday, NIAID director Anthony Fauci warned that daily U.S. coronavirus infections could top 100,000 if current outbreaks aren't curbed. Meanwhile, Fauci joined CDC director Robert Redfield in urging officials to help debunk vaccine skepticism ahead of a successful shot—and the looming school year. The CDC has spent the past three months building a plan to boost "vaccine confidence," Redfield said. 

A lowly 2% of U.S. patients are currently taking dexamethasone for COVID-19 despite that drug's recent buzz, data analysis firm CarePort Health told Fierce Pharma. Some other highlights from CarePort's usage analysis? Use of remdesivir stalled at 1% to 2% of coronavirus patients from May until late June, when the drug saw a 15% spike, and hydroxychloroquine use plunged to 1% in early June, well before the FDA axed its emergency authorization. The antibiotic azithromycin peaked at 50% in March before dropping to its current 28%. 

UPDATED: Tuesday, June 30 at 9:30 a.m. ET

AbbVie's HIV treatment Kaletra, failed to help patients hospitalized with COVID-19, the U.K.'s Recovery Trial found. Among 1,596 patients dosed with Kaletra—a combination of the antivirals lopinavir and ritonavir—22.1% died, compared with 21.3% of patients in the control group. Plus, the drug had no effect on disease progression or length of hospital stay. The stats dispel hopes for Kaletra's use in coronavirus patients, the trial investigators said, and they shut down enrollment in that arm of their study. 

Inovio turned in strong interim data from a phase 1 test of its DNA-based vaccine, now tapped to take part in Operation Warp Speed challenge trials, the company said. Forty healthy adults each received two doses two weeks apart. By week six, 34 out of 36 patients—around 94%—had generated an immune response with minimal side effects, Inovio said, and four dropped out. The company aims to launch phase 2/3 trials in older adults this summer. 

The FDA plans to offer strict guidance on COVID vaccine hopefuls Tuesday. To win approval, a vaccine will need to prove 50% more effective than a placebo, and its safety must be confirmed in clinical trials, the FDA said. Post-marketing studies will be required for approved vaccines, and patients should be monitored for a year after dosing.

Hyderabad-based Bharat Biotech said Monday that it had developed India's first COVID-19 vaccine candidate, Covaxin, and won approval from the country's drug regulator to start phase 1/2 trials in July. Bharat, which previously developed a successful flu shot, created the coronavirus prospect in partnership with the Indian Council of Medical Research and the National Institute of Virology.

Mexico is in talks with the Chinese government, private Chinese labs, and the University of Oxford and AstraZeneca to run COVID-19 vaccine trials in the country, a government official told Reuters. 

Plus, hydroxychloroquine could make a comeback as the U.K.'s Medicines and Healthcare Products Regulatory Agency gave its blessing to restart trials on the drug in Bangkok. The study, dubbed COPCOV, aims to enroll 40,000 healthcare workers and other at-risk staffers, led by Oxford University’s Mahidol Oxford Tropical Medicine Research Unit. 

And NIAID director Anthony Fauci plans to testify before Congress Tuesday for the second time in two weeks. At a tense hearing before House lawmakers last week, the FDA broke with the White House's pandemic advice and Fauci warned of troubling resurgences across the country. Today, Fauci will again join top officials from the CDC and FDA in a bid to address the latest spikes in at least 30 states. 

UPDATED: Monday, June 29 at 3:35 p.m. ET

The wait for remdesivir pricing is over as CEO Daniel O'Day revealed Monday that Gilead Sciences had set a list price of $520 per vial, or $3,120 for the five-day, six-vial course most patients are expected to receive. That falls well below the $5,000 price tag some Wall Street analysts had rooted for, but drug cost watchdog the Institute for Clinical and Economic Review called the final price responsible. And even at the $2,340 government purchase price, Gilead could still nab around $2.3 billion in 2020 sales of the antiviral, one analyst said. Story

A plasma-based treatment could beat a COVID vaccine to market, or so says the R&D chief of Takeda's plasma therapies unit, Chris Morabito. The Japanese drugmaker has joined CSL Behring and a suite of plasma specialists to develop a hyperimmune globulin—made by purifying plasma from recovered patients—that gives patients multiple antibodies to fight the virus. Takeda will work with the group to deliver a single, unbranded medicine, potentially by year's end, Morabito said. Story

Beckman Coulter scored an emergency approval from the FDA to deliver more than 30 million coronavirus antibody tests per month worldwide, with shipping already underway at more than 400 U.S. hospitals, clinics and labs, the company said. The mass-produced test can run on a variety of manufacturers' machines, plus the company's own Access 2 tabletop device