AstraZeneca has secured over $1 billion from the HHS‘ Biomedical Advanced Research and Development Authority (BARDA) to develop and supply its Oxford University-partnered vaccine.
China’s CanSino Biologics, already the development frontrunner with a recombinant vaccine, has signed up Precision NanoSystems to work on an mRNA liquid nanoparticle shot.
GSK Consumer Healthcare formed an alliance with Mammoth Biosciences to develop a CRISPR-based at-home COVID-19 test.
Survey Report
Direct-to-Patient Supply: Industry Perception and Future Trends
To better understand sponsors’ perspectives on DTP and interest in using it in their studies, Catalent and FiercePharma surveyed 234 individuals involved in clinical supply and operations. Download this infographic to read the results.
As of Thursday morning, the global case count had surpassed 5 million, and more than 328,000 people had died, according to Johns Hopkins University’s COVID-19 dashboard.
Please read below for the latest updates. We’ll chronicle the latest on this page. Our daily COVID-19 tracker entries from Jan. 30 through April 20 are here.
UPDATED: Thursday, May 21 at 9:36 a.m. ET
Following the U.K. government, BARDA is awarding AstraZeneca more than $1 billion to supply the University of Oxford’s vaccine candidate. The British drugmaker is also in talks with international organizations and potential partners, including India’s Serum Insitute, to increase production and access.
China’s CanSino Bio is already testing a recombinant coronavirus vaccine in China, but it’s jumping on the mRNA vaccine bandwagon through a licensing deal with Precision NanoSystems. Story
Moderna is currently the leader in the mRNA vaccine space, but Evercore ISI analyst Umer Raffat is raising doubts about the strength of preliminary phase 1 data the biotech recently posted. Story
AstraZeneca previously invested in Moderna. Now, its 7.7% stake in the mRNA specialist is worth more than $2 billion.
Meanwhile, Inovio said its DNA vaccine candidate elicited strong neutralizing antibody and T-cell responses in mice and guinea pigs. Data from an ongoing phase 1 test is expected in June.
GSK Consumer Healthcare has partnered with Mammoth Biosciences to develop a hand-held, at-home COVID-19 test based on the latter’s CRISPR platform. The final product is said to have the potential to deliver point-of-use results in less than 20 minutes.
Apple and Google are rolling out a software toolkit that can be used to quickly notify people if they’ve had close contact with a person diagnosed with COVID-19. Story
Roche has launched its Elecsys Anti-SARS-CoV-2 antibody test at more than 20 U.S. sites, with plans to increase to more than 200 commercial and hospital lab sites in the next several weeks and the ability to perform millions of tests per week.
Michael Ryan, the WHO’s emergencies chief, said hydroxychloroquine—which President Donald Trump has endorsed and said that he‘s taking—should only be used in controlled clinical trials before its utility in COVID-19 is confirmed.
UPDATED: Wednesday, May 20 at 8:45 a.m. ET
Roche is already running a clinical trial dubbed COVACTA testing Actemra’s ability at controlling severe immune overreaction in hospitalized COVID-19 patients. Earlier this month, the company’s Genentech unit has launched a new trial of the IL-6 inhibitor at hospitals that largely treat underserved and minority patient populations. The study, coded EMPACTA, has dosed its first patient on May 14 in New York with the aim to enroll about 375 patients.
Data reported to Japan’s health ministry by hospitals treating patients with mild or no symptoms found Fujifilm’s Avigan offered no clear benefits, Kyodo reported, citing people familiar with the matter. Japanese Prime Minister Shinzo Abe has said he is hoping to approve the flu drug for COVID-19 by the end of May.
Early in the outbreak, Pfizer CEO Albert Bourla knew medical solutions for COVID-19 would be needed, according to a Forbes article on the company’s response. He directed the company’s scientists to work as quickly as possible on a vaccine, putting $1 billion on the line.
During a cabinet meeting on Tuesday, President Donald Trump called a study that had found no benefit from hydroxychloroquine in a group of veterans a „phony study“ and claimed it was done by „obviously not friends of the administration“ who wanted to „make political points.“
Patrick Soon-Shiong’s NantKwest has won FDA clearance to test its mesenchymal stem cell treatments in severe COVID-19 patients with acute respiratory distress syndrome and cytokine storm.
Meanwhile, despite strong opposition from the health community, Brazilian President Jair Bolsonaro is poised to loosen protocols around the use of chloroquine for mild coronavirus cases. He has ordered the military to ramp up production of the drug.
People with Type 1 diabetes are three and a half times more likely to die than non-diabetics who catch COVID-19 while Type 2 patients are twice as likely to die than non-diabetics, NHS England has found.
UPDATED: Tuesday, May 19 at 2:52 p.m. ET
Covis Pharma, a biopharma company headquartered in Luxembourg, has started a phase 3 trial of its Alvesco inhaler in non-hospitalized COVID-19 patients 12 and older. The placebo-controlled study will recruit 400 patients at multiple sites in the U.S.
After President Donald Trump said he has been taking hydroxychloroquine to prevent against COVID-19, Vice President Mike Pence said he’s not on the drug, Fox News‘ Kristin Fisher reports.
More from the VP on why he is not taking Hydroxychloroquine:“My physician hasn’t recommended that, but I wouldn’t hesitate” to take it if he did recommend it.And lots more on the big @NASA @SpaceX launch next week coming soon
— Kristin Fisher (@KristinFisher) May 19, 2020
A retrospective data analysis from UnitedHealth and the Yale School of Medicine found that older COVID-19 patients with hypertension on ACE inhibitors had a significantly lower risk of hospitalization, prompting the need for further research.
UPDATED: Tuesday, May 19 at 10:32 a.m. ET
Gilead Sciences has pledged to donate its current supply of 1.5 million doses of remdesivir, of which 607,000 vials are being allocated to the U.S. government. Now, the biotech is increasing its U.S. donation to about 940,000 doses by June.
Before the donated supply runs out in June or early July, Gilead is preparing to pivot to a commercial model and start charging for remdesivir in the second half of the year, SVB Leerink analyst Geoffrey Porges wrote to clients after talking to senior management. The company also envisages remdesivir becoming a „multi-year commercial opportunity,“ he said.
Meanwhile, Cipla, which is one of four drugmakers with nonexclusive remdesivir licensing deals, is also looking at combo treatment options for COVID-19, including teaming Fujifilm’s flu drug Avigan (favipiravir) with the Gilead med.
AstraZeneca has an ongoing collaboration to help manufacture a vaccine candidate by the University of Oxford, with funding from the U.K. government. The British drugmaker is in talks with other organizations and governments to strike similar deals. Story
On the heels of unveiling early results for its mRNA vaccine, Moderna plans to raise $1.34 billion through a stock sale to help produce the shot if it crosses the regulatory finish line. Story
Moncef Slaoui, the newly appointed U.S. coronavirus czar, will divest his $10 million in Moderna stock options, which shot up in value Monday after the company unveiled promising early data.
The Trump administration has signed a $354 million four-year deal with with a new Virginia company called Phlow to produce generic drugs and APIs needed to treat COVID-19 in an effort to bring pharma manufacturing back to the U.S., The New York Times reported. The contract, awarded by the Biomedical Advanced Research and Development Authority, may be extended for a total of $812 million over 10 years.
Canada has allowed China’s CanSino Bio to begin clinical testing of its adenovirus-based COVID-19 vaccine, currently the most advanced program in any part of the world.
The U.S. CDC plans a nationwide antibody study of up to 325,000 people to track how the novel coronavirus spreads, according to Reuters.
President Donald Trump is threatening to make his „temporary freeze of United States funding to the World Health Organization permanent and reconsider our membership in the organization“ if the group doesn’t take on the reforms he’s proposed over its links to China.
UPDATED: Monday, May 18 at 3:41 p.m. ET
Moderna shares leapt as the company unveiled early phase 1 data showing its vaccine candidate, mRNA-1273, elicited neutralizing antibodies in eight trial participants available for analysis. Based on the data, The company said its own phase 2 trial will be amended to study two dose levels, 50 µg and 100 µg. Story
Meanwhile, CureVac is ramping up its own vaccine research efforts, and has rolled out preclinical results ahead of a planned phase 1/2a study next month. Story
Verily launched a new clinical research effort focused on COVID-19, with an initial focus on coronavirus antibody testing. Run through its Project Baseline initiative, the program will also recruit healthy individuals to gauge the wider impact of the disease on mental health, lifestyle and more. Story
Fitbit plans to leverage its supply chain to start building its own COVID-19 ventilator, and hopes to submit its designs to the FDA in the near future. The prototype device includes more features than the typical emergency alternatives, but is designed to be cheaper than the more durable hospital devices. Story
The FDA authorized an at-home sample collection kit from Everlywell that works with multiple coronavirus diagnostic tests. Story
Teva walked away from negotiations with federal prosecutors, daring the U.S. Department of Justice to pursue criminal price-fixing charges against the drugmaker at a time when it’s part of the COVID-19 pandemic response. Story
Microsoft and UnitedHealth Group launched a simple smartphone app for digitally screening employees based on reported COVID-19 symptoms, to help clear those who can return to work. Story
AstraZeneca aims to answer questions that COPD and asthma patients may have when it comes to COVID-19, through an unbranded TV ad and a company YouTube channel with tips on navigating exercise, grocery shopping and telemedicine. Story
UPDATED: Monday, May 18 at 9:22 a.m. ET
On the heels of Moncef Slaoui’s appointment as the leader of Trump administration’s COVID-19 vaccine accelerator, Operation Warp Speed, the former GlaxoSmithKline exec has resigned from Moderna’s board. But he still holds stock options worth $10 million in the biotech, which has received federal funding for its mRNA project. Calling it a „huge conflict of interest,“ Sen. Elizabeth Warren called on Saloui to „divest immediately.“
It is a huge conflict of interest for the White House’s new vaccine czar to own $10 million of stock in a company receiving government funding to develop a COVID-19 vaccine. Dr. Slaoui should divest immediately. https://t.co/8IWLxVL7la
— Elizabeth Warren (@SenWarren) May 15, 2020
Moderna shares leapt Monday as the company unveiled early phase 1 data showing its vaccine candidate, mRNA-1273, elicited neutralizing antibodies in eight trial participants available for analysis. Based on the data, The company said its own phase 2 trial will be amended to study two dose levels, 50 µg and 100 µg.
The EU could grant Gilead’s remdesivir an conditional nod in the „coming days,“ EMA head Guido Rasi said on Monday at a hearing at the EU Parliament in Brussels.
The Seattle Coronavirus Assessment Network (SCAN), which has won support from the Bill & Melinda Gates foundation, said it’s suspending its at-home COVID-19 test after the FDA tightened guidelines to require emergency approval first. “The FDA has not raised any concerns regarding the safety and accuracy of SCAN’s test, but we have been asked to pause testing until we receive that additional authorization,” the organization said.
Indian drugmakers have managed to increase manufacturing capacity to around 50% to 60% even as lockdowns in key areas of the country continue. Shipping and congestion at ports remain major hurdles to supply.
The Chinese government is pushing back against the Trump administration’s accusations around its response to the coronavirus, floating its own theory of the pathogen’s origin.
The U.S. Navy says 13 sailors from the USS Theodore Roosevelt who had recovered from the coronavirus with clear negative test results have now tested positive again.
UPDATED: Friday, May 15 at 3:05 p.m. ET
In a Rose Garden address soon after his appointment as the head of the Trump administration’s project „Warp Speed“ to accelerate a COVID-19 vaccine, former GSK exec Moncef Slaoui said data from an unnamed vaccine „made me feel even more confident that we will be able to deliver a few hundred million doses of vaccine by the end of 2020.“ Slaoui has been a board member at Moderna, which is developing an mRNA vaccine for COVID-19; he has left the board now that he has accepted the new post. Story
Manufacturing specialist Univercells has inked a new deal to provide prefabricated vaccine development facilities to help speed the production of potential COVID-19 shots. Story
The FDA has issued another umbrella-style Emergency Use Authorization, covering infusion pumps, devices and accessories that are in high demand for treating patients with COVID-19. Story
The U.S. government is aiming to stockpile doses of promising COVID-19 vaccines to have hundreds of millions of doses ready to go if any pass regulatory scrutiny, Department of Health and Human Services Secretary Alex Azar told Fox News.
An Oxford University professor developing a potential COVID-19 vaccine told Reuters that the shot „won’t be expensive.“ Oxford has plans to commercialize its vaccine with AstraZeneca.
UPDATED: Friday, May 15 at 9:23 a.m. ET
Sanofi CEO Paul Hudson’s comment that the U.S. „has the right to the largest pre-order“ of its COVID-19 vaccine drew a backlash from French President Emmanuel Macron and Prime Minister Edouard Philippe. So the French pharma’s chairman, Serge Weinberg, intervened, promising no country would get priority.
The NIH is adding a new regimen to its ACTG clinical programs. This time, it will test hydroxychloroquine—which has won public endorsement from President Donald Trump—alongside the antibiotic azithromycin in a phase 2b trial that will enroll approximately 2,000 mild-to-moderate patients. Teva will supply the antimalaria drug for the study for free.
Meanwhile, an observational study in France and a randomized trial in China both found hydroxychloroquine offered no additional benefits over standard of care in hospitalized patients.
China now has five potential COVID-19 vaccines in clinical testing, with an aggregate 2,036 volunteers already dosed at the phase 2 stage, Zeng Yixin, vice minister of China’s National Health Commission, said at a press briefing Friday.
After a preliminary study by researchers at NYU Langone Health found Abbott’s rapid, point-of-care coronavirus test could miss nearly half of positive cases, the company said it would change its instructions for the ID Now device to tell users that negative results are „presumptive“ and should be verified with an alternative test for patients with signs of the virus.
A research team at the Institut Pasteur Korea suggested that pancreatitis drug nafamostat appears to be much more effective than remdesivir. Previously, a team at the University of Tokyo found the drug could effectively block the viral entry process of the new coronavirus. A clinical trial of the drug started in April, according to clinicaltrials.gov.
Despite the urgent need to develop COVID-19 vaccines and treatments, big investment firms are not enthusiastic about putting down the bets. Why? Such a drug might not result in big profits for shareholders. “We are all cheering for a treatment on a humanitarian level, but as an investor, you have to believe a treatment works, and that sales last long enough for it to have a material impact on a company,” Larry Robbins, who runs health-care hedge fund Glenview Capital Management, told The Wall Street Journal.
UPDATED: Thursday, May 14 at 2:45 p.m. ET
A new study measuring the performance of Abbott’s rapid, point-of-care coronavirus test found the device could miss nearly half of positive cases, depending on how the samples were handled and fed into the machine. Conducted by researchers at NYU Langone Health, the study has not yet been peer-reviewed. Story
The FDA is working with the Centers for Disease Control and Prevention to develop a „phased approach“ to restarting on-site drug manufacturing facility inspections, which have been halted since March. Story
The National Institutes of Health launched a new study of generic antimalarial hydroxychloroquine and antibiotic azithromycin with mild to moderate COVID-19. That drug combination once touted by President Donald J. Trump has been met with mixed clinical results.
A novel coronavirus vaccine being developed by researchers at Oxford University has passed a small-scale primate study, Reuters reported. Oxford recently reached a deal with British drugmaker AstraZeneca to commercialize the vaccine, which the university said could be ready for human patients by the end of the year.
Russian drugmaker Chemrahr said it was testing generic antiviral Avigan in phase 2 and 3 trials based on criteria from the World Health Organization, Reuters reported. The drug secured $2 million in funding from the Russian Direct Investment Fund.
The BMJ warned that a “deluge of poor quality research [in COVID-19] is sabotaging an effective evidence-based response,” while Nature argued that more patients are needed for better trial results. Story
UPDATED: Thursday, May 14 at 10:05 a.m. ET
Shortly after Sanofi CEO Paul Hudson suggested his company would offer the first batches of a potential COVID-19 vaccine to the U.S. because the country stepped up with early funding, Agnes Pannier-Runacher, France’s deputy finance minister, slammed such „privileged access“ as „unacceptable.“
The Trump administration is reportedly planning to appoint Moncef Slaoui, formerly head of GlaxoSmithKline’s vaccines business, as the leader of „Operation Warp Speed,“ an initiative aimed at accelerating the development of a COVID-19 vaccine. Slaoui currently holds a board seat at Moderna, which is working on an mRNA vaccine candidate.
In a new guideline, the American College of Physicians says current evidence does not support the use of the antimalarial drugs chloroquine or hydroxychloroquine, either alone or in combination with azithromycin, to prevent or treat COVID-19.
Meanwhile, Novartis CEO Vas Narasimhan, who led the Swiss drugmaker’s vaccine development efforts during the 2009 H1N1 pandemic, said a COVID-19 vaccine may only become available in the second half of next year.
Marco Cavaleri, the EMA’s head of vaccines, also said a vaccine could be approved in about a year in an “optimistic” scenario.
Speaking of vaccines, Greenlight Biosciences, which is developing mRNA vaccine candidates, has raised $17 million to scale up its production capacity targeting the production of billions of doses of COVID-19 vaccine.
Netherlands biotech Intravacc said it has developed three COVID-19 vaccine concepts based on its outer membrane vesicle technology.
Influential journals The BMJ and Nature have come forward with warnings that COVID-19 research, while urgently needed, should still maintain high quality. They pointed out that many clinical trials on potential treatments are poorly designed and yield no meaningful results. Story
After a fast-tracked approval, Japan has already started distributing Gilead Sciences‘ remdesivir to hospitals. The drug is being used for patients in intensive care or on ventilators.
Takeda has committed to donating JPY 2.5 billion ($23 million) across three United Nations-led organizations to support the UN COVID-19 Global Humanitarian Response Plan.
Exyte and Univercells Technologies have formed a partnership for optimized construction of modular standardized and flexible GMP manufacturing facilities for vaccines in response to potential global demand for COVID-19 vaccines upon approval.
UPDATED: Wednesday, May 13 at 3:15 p.m. ET
Because the U.S. stepped up first to invest in the company’s research, Sanofi CEO Paul Hudson told Bloomberg the country “has the right to the largest pre-order“ of the drugmaker’s potential COVID-19 vaccine.In fact, the government expects to be rewarded with quick access, Hudson says, after BARDA signed on in February to collaborate with the French drugmaker. Story
Thermo Fisher Scientific is developing its own COVID-19 antibody test through an ongoing, three-way collaboration with WuXi Diagnostics and the Mayo Clinic, and plans to seek international authorizations for the test over the next few weeks. Story
The FDA authorized devices and algorithms from Philips, Eko and Caption Health to diagnose patients with preexisting cardiovascular diseases have a higher risk of dying from COVID-19. The devices are also, in part, designed to help limit healthcare providers’ exposure to the disease. Story
Russia suspended the use of Aventa-M ventilators after some of the devices were linked to fatal fires, Reuters reported. Some of those unites were sent to the U.S. in April but were not needed for use, officials said.
UPDATED: Wednesday, May 13 at 8:58 a.m. ET
Even if Moderna succeeds with its unproven vaccine platform, the biotech won’t be able to make enough doses for the entire world, CEO Stephane Bancel said. He’s hoping several vaccine makers make it to the finish line to share the load.
Celltrion secured funding from the Korean government to advance MERS and COVID-19 pipeline medicines.
Hackers from China and Iran have been targeting American companies and researchers working on COVID-19 drugs and vaccines since early January, officials say.
After Gilead inked a series of licensing deals for remdesivir, Public Citizen argued the drug should be in the public domain. The company’s current approach picks „winners and losers,“ the group said.
Some of former BARDA director Rick Bright’s colleagues say his whistleblower complaint left out some key details, Politico reports.
Researchers at the Washington University School of Medicine are testing the antidepressant fluvoxamine for its potential to help prevent immune system overreactions in COVID-19 patients.
A team in Denmark is studying whether sickle cell anemia medicine senicapoc could help reduce lung damage from COVID-19.
Authorities in Japan are allowing pharmaceutical companies to bypass certain requirements to seek regulatory approval for potential COVID-19 medicines, including Fujifilm’s Avigan.
With many small, independent COVID-19 studies taking place around the world, an editorial in Nature argued for more scientific collaboration.
The U.K. government unveiled a plan to sequence genes of 35,000 COVID-19 patients in an effort to learn more about the virus and discover treatments.
After dozens of cases of pediatric multisystem inflammatory syndrome in New York City, healthcare systems are ramping up a testing effort for children.
UPDATED: Tuesday, May 12 at 2:53 p.m. ET
Gilead inked licensing deals with generic drugmakers Cipla, Ferozsons Laboratories, Hetero Labs, Jubilant Lifesciences and Mylan allowing those companies to manufacture and distribute remdesivir in 127 countries, royalty-free.
With at least eight COVID-19 vaccines in human testing, NIAID director Anthony Fauci said he’s „cautiously optimistic“ one or more could work. Story
India-based Glenmark Glenmark is starting a phase 3 study of favipiravir, the generic of Fujifilm’s Avigan, in COVID-19 patients in its home country.
Deaths from delays in routine medical care due to lockdowns could rival the toll from COVID-19, experts wrote in the Wall Street Journal.
UPDATED: Tuesday, May 12 at 9:01 a.m. ET
At a Senate hearing today, NIAID director Anthony Fauci plans to warn of „needless suffering and death“ if the U.S. reopens too soon, the New York Times reports. The heads of the CDC and FDA will also testify at the hearing.
The European Medicines Agency expanded its compassionate use guidelines for Gilead’s remdesivir. Originally, the drug was recommended for patients requiring mechanical ventilation. It’s now recommended for certain hospitalized patients.
After ramped-up ventilator supplies helped forestall feared shortages—and the tough decisions physicians might have had to make in allocating them—didn’t materialize, doctors are now worried about having to ration remdesivir due to supply constraints, CNN reports.
In a retrospective study of more than 1,400 people in New York, treatment with hydroxychloroquine, azithromycin, or both, did not improve survival rates for hospitalized patients.
The FDA added two medicines that used to put patients onto ventilators to its list of drug shortages.
John Burkhardt, Pfizer’s site leader at an R&D facility in Groton, Connecticut, told local newspaper The Day he believes „science will win“ in the fight against the pandemic. The company is exploring numerous approaches to fight the virus.
Early in the remdesivir rollout, the U.S. made mistakes with initial shipments, Coronavirus Task Force member Dr. Deborah Birx acknowledged in an email to colleagues covered by the Wall Street Journal.
There was „unanimity within the institute“ that NIAID should stop its placebo-controlled remdesivir study early based on positive effects from the drug, an official told Stat. Gilead’s remdesivir has won an emergency use authorization from the FDA based on the trial data.
The FDA updated COVID-19 therapy guidelines in an effort to help drugmakers speed up their regulatory submissions.
UPDATED: Monday, May 11 at 3:35 p.m. ET
Two White House staffers have tested positive for COVID-19, and FDA Commissioner Stephen Hahn, NIAID Director Anthony Fauci and CDC Director Robert Redfield are placing themselves into partial or full quarantines for two weeks. Story
Wearing masks in the White House is now mandatory, according to ABC News, following a new policy instituted Monday afternoon. Additionally, Hahn, Fauci and Redfield will testify before the House of Representatives via teleconference this week, regarding ways to reopen the economy.
Meanwhile, the FDA authorized its first COVID-19 antigen test, bringing a new category of diagnostic against the disease. Similar to the rapid, swab-based tests used for the flu, antigen tests detect unique protein fragments found on the outer walls of the novel coronavirus. Quidel’s Sofia 2 test kit is designed for the point-of-care, such as in hospitals, urgent care clinics, doctor’s offices and elsewhere. Story
The agency also gave a new diagnostic green light allowing a saliva-based coronavirus test to be used at home, letting people mail in their own samples for analysis. The authorization expands the use of the spit test developed at Rutgers University. Story
To gear up for a manufacturing blitz that may see hundreds of millions of vaccine doses, Pfizer is trading off resources slated for its existing medications. The Big Pharma plans to outsource the production of some of its portfolio to its 200-strong network of contractors. Story
Elsewhere, Immunomedics raised $459 million in a stock offering to help launch its first-in-class Trodelvy therapy in triple-negative breast cancer—as the pandemic impacts efforts for the new antibody-drug conjugate. Story
As various countries rush to develop vaccines and treatments, the FBI and the Department of Homeland Security are preparing to issue a warning that hackers tied to the Chinese government are trying to steal „valuable intellectual property“ about vaccines, treatments and testing „through illicit means.“ Story
What’s it like to work on a coronavirus vaccine? For J&J immunologist and discovery team leader Rinke Bos, it’s social distancing in the lab, remote work and late nights at home. Story
Charles River Labs revised its year-long guidance, warning of “a significant impact on the research models and services revenue growth rate” in this year’s second quarter. The CRO expects the COVID-19 pandemic to reduce 2020 revenue by about $135 to $215 million. Story
Twitter announced that it would label specific tweets containing disinformation about the pandemic. While the warnings won’t provide active fact-checking, they may direct users to more-curated information.
UPDATED: Monday, May 11 at 9:10 a.m. ET
Physicians and hospitals have already expressed frustrations about the difficulty obtaining Gilead Sciences‘ remdesivir. Now, an HHS distribution plan shows that only 607,000 vials of the emergency use drug will be made available to U.S. patients over the next six weeks, out of a total donation of about 1.5 million. RBC Capital analyst Brian Abrahams said that supply is likely „significantly constrained“ given the current infection rate.
And amid the chaotic rollout of remdesivir, former FDA commissioner Scott Gottlieb said on CBS News that the government needs a „better system“ for distributing coronavirus therapeutics.
Meanwhile, Regeneron CEO Len Schleifer told CNN that he’s worried the U.S. doesn’t have enough capacity to manufacture potential COVID-19 treatments or vaccines.
Elias Zerhouni, who was NIH director under former President George W. Bush before a seven-year stint with Sanofi’s research business, is leading a narrowing pack for the position of COVID-19 czar. HHS Secretary Alex Azar “personally prefers Zerhouni for the role,” one person familiar with the matter told Politico. Story
Pfizer is in talks to transfer more of its drug production to outside contractors, including Catalent, Lonza and Thermo Fisher, Mike McDermott, president of global supply at Pfizer, told Reuters. The New York pharma is making the moves as it prepares for large-scale production of its BioNTech-partnered experimental COVID-19 vaccine.
Zydus Cadila has been tapped by the Indian government for mass production of the country’s first homegrown ELISA-based SARS-CoV-2 antibody test kit, which was developed by the National Institute of Virology. The test is said to be able to handle 90 samples in a single run of 2.5 hours.
Israeli company RedHill Biopharma has won FDA clearance to run a clinical trial of its drug opaganib in 40 patients with moderate to severe COVID-19. The drug previously showed early promise in a small group of Israeli patients.
UPDATED: Friday, May 8 at 3:20 p.m. ET
Gilead Sciences may have been the target of Iranian hackers using fake email login pages to access confidential data, Reuters reported. In one case, a fake login page was sent to a legal and corporate affairs executive in April. Reuters couldn’t confirm whether the attack was successful.
Speaking of Gilead, the National Institutes of Health will pair the drugmaker’s COVID-19 antiviral remdesivir with Eli Lilly’s rheumatoid arthritis drug Olumiant in a new study in U.S. hospitalized patients. The trial will eventually enroll 1,000 patients across 100 sites, the NIH said.
The FDA published results from the first batch of COVID-19 antibody diagnostics to have their accuracy independently evaluated by federal laboratories—starting with 12 blood tests the agency had already authorized for emergency use against the pandemic. Story
One of the antibody tests, from Abbott Laboratories, was found to be extremely effective in detecting whether individuals previously had COVID-19. The Washington School of Medicine reported in the Journal of Clinical Microbiology that Abbott’s test had a specificity of 99.9% and a sensitivity of 100%, suggesting very few false positives and no false negatives, Reuters reported.
Global Blood Therapeutics‘ sickle cell disease medicine Oxbryta got off to a hot start after a November FDA approval. But early in its launch, execs now say they’re seeing a „clear headwind“ from the COVID-19 pandemic. Story
UPDATED: Friday, May 8 at 9:00 a.m. ET
Hydroxychloroquine has failed an observational study in New York. According to a paper published in The New England Journal of Medicine, researchers found no significant difference between hydroxychloroquine and standard care in terms of patients‘ need for ventilation or death rate. But the team does stress that additional randomized clinical trials are needed.
After the FDA’s emergency use authorization, Gilead donated its entire stockpile of remdesivir to the government for further distribution. But the drug hasn’t reached those most in need, according to Axios. „Some went to the wrong places, some went to the right places,“ one senior Trump administration official said. „We don’t know who gave the order. And no one is claiming responsibility.“
Teva has confirmed its full-year revenue guidance of between $16.6 billion and $17 billion. While some of its generics and over-the-counter products got a sales boost during the pandemic, sales of others, such as migraine drug Ajovy, slowed. “Depending on how long these situations last … these things work in a way for us where they more or less balance each other off,” CEO Kåre Schultz told Barron’s.
Shionogi said it plans to begin clinical trials of its coronavirus vaccine by the end of the year, expecting to launch it as early as fall 2021.
Meanwhile, Chinese vaccine maker Sinovac is talking to foreign regulators and the World Health Organization to launch phase 3 clinical trials of its inactivated vaccine outside of China, CEO Yin Weidong told Bloomberg.
Sorrento Therapeutics has teamed up with Mount Sinai Health System to develop an antibody cocktail that binds to three different epitopes of the novel coronavirus‘ spike protein. Story
India’s Cadila Pharmaceuticals has shut down its formulations manufacturing plant in Ahmedabad, India, after 26 employees tested positive for the new coronavirus. And 95 employees who may have come in contact with the infected workers have been quarantined. Story
UPDATED: Thursday, May 7 at 3:10 p.m. ET
Endo International withdrew its 2020 guidance due to COVID-19 uncertainties. The company expects the pandemic to affect an upcoming launch, plus patient recruitment and site selection for new and ongoing clinical studies.
Sareptha Therapeutics‘ Vyondys 53 rollout in Duchenne muscular dystrophy hit a snag as doctors were unable to administer patients‘ initial doses before they transition to home infusions, RBC Capital Markets analysts wrote in a note to clients. The company’s net sales of $100 million during the first quarter missed expectations.
Alynlam lowered its 2020 revenue guidance for Onpattro by 5% due to the pandemic and is taking „thoughtful“ steps to cut costs.
UPDATED: Thursday, May 7 at 8:20 a.m. ET
Gilead Sciences‘ remdesivir won approval in Japan as Veklury. It’s the first full global nod for the COVID-19 treatment following the U.S. emergency use authorization last week. Authorities in Japan approved the drug under an „exceptional approval“ regulatory pathway.
Meanwhile, Gilead spent about $50 million on remdesivir manufacturing scale-up and clinical trial costs during the first quarter, the biotech said in its quarterly securities filing. It also warned of possible COVID-19-related delays with the FDA’s review of its application for JAK inhibitor filgotinib in rheumatoid arthritis.
And now, as Gilead works to increase supplies after last month’s FDA emergency authorization, many U.S. hospitals are still having a hard time getting the drug for their patients. „There are people who are getting diagnosed right now who qualify for treatment and don’t have access to it,“ an infectious disease and critical care physician at the University of Virginia told Business Insider.
Moderna is planning an „imminent“ start to a 600-participant phase 2 trial of its mRNA vaccine candidate, mRNA-1273, after the FDA cleared its trial protocol. The company’s goal is to initiate a phase 3 study „early this summer“ and win approval as soon as 2021, CEO Stéphane Bancel said. Story
GlaxoSmithKline has identified its investigational anti-GM-CSF antibody otilimab—already in trials for arthritis—as a potential treatment for severe inflammatory symptoms in hospitalized patients with COVID-19. The company expects to start a midstage trial in the coming weeks. Story
Pfizer, in its collaboration with BioNTech, will mass produce its COVID-19 vaccine at three sites if it’s proven efficacious. Its Andover, Massachusetts, site will be used for drug substance manufacturing, while a site in St. Louis will be used for critical raw material manufacturing. Another in Kalamazoo, Michigan, will handle formulation and fill. Story
The NIH will test a plasma-derived hyperimmune globulin therapy by an alliance formed by Takeda, CSL Behring and others. The global clinical trial is expected to start in the summer and will form the foundation for potential regulatory approvals, Takeda said.
Despite a strong first quarter, CRO giant PPD has pulled its full-year guidance after “some customers have delayed new studies and/or paused ongoing studies or certain activities in ongoing studies, such as patient recruitment, patient enrollment, site visits and site monitoring.” Story
In a change of course, President Donald Trump now says the U.S. coronavirus task force will continue indefinitely rather than winding down as he had previously said.
The task force will be “very focused” on the development of a coronavirus vaccine and treatments, the president said, and he promised to announce „two or three new members to the task force“ as soon as Monday. Many healthcare providers and public health officials say they are still lacking protective equipment and have far fewer diagnostic tests than they need.
….gloves, gowns etc. are now plentiful. The last four Governors teleconference calls have been conclusively strong. Because of this success, the Task Force will continue on indefinitely with its focus on SAFETY & OPENING UP OUR COUNTRY AGAIN. We may add or subtract people ….
— Donald J. Trump (@realDonaldTrump) May 6, 2020
Scientists are now questioning the findings in a recent study that claims a more transmissible form of the novel coronavirus has emerged and has been spreading in Europe since early February, according to The Atlantic.
UPDATED: Wednesday, May 6 at 3:20 p.m. ET
Gilead Sciences says it’s in licensing talks with the “world’s leading chemical and pharmaceutical manufacturing companies” about their ability to produce remdesivir for countries in Europe, Asia and beyond until at least 2022. Story
Eli Lilly has agreed to pay $10 million upfront and committed up to $245 million for ex-China rights to co-develop and sell neutralizing antibodies from China’s Junshi Biosciences to fight COVID-19. The pair aims to apply to start a clinical trial in the U.S. in the second quarter. Story
Medical device association AdvaMed launched a new online platform to put ventilator manufacturers in touch with potential suppliers of much-needed components, as more companies across a variety of industries pivot their resources toward the novel coronavirus pandemic. Story
Sidelined by the novel coronavirus pandemic, Team Novo Nordisk, a professional cycling team sponsored by the drugmaker, has taken to Twitter, Instagram, Facebook and LinkedIn with news, interviews, training tips, throwbacks to past races, contests (#GuessTheRider) and general encouragement for diabetes patients. Story
UPDATED: Wednesday, May 6 at 9:15 a.m. ET
Sanofi, in collaboration with GlaxoSmithKline, aims to start a phase 1/2 study of their vaccine in September, with a goal of enrolling hundreds of subjects, John Shiver, Sanofi Pasteur’s vaccine R&D chief, said. Late-stage trials with thousands of subjects are expected to take place by year-end or early 2021, he told Reuters.
Roche’s phase 3 trial of Actemra has enrolled half of its planned 330 patients, Genentech CEO Alexander Hardy said in an interview with the Neue Zuercher Zeitung, according to Reuters. „We’ll be finished in May or June,“ he added.
Meanwhile, Roche CEO Severin Schwan told ABC News that the Swiss pharma is meeting aggressive production targets with its antibody test and will be able to produce 60 million tests by the end of May. He said the engagment and commitment from employees are „really enormous.“
Gilead Sciences‘ remdesvir could be approved in Japan Thursday right after the health ministry’s review board meets that day, Japanese Health Minister Katsunobu Kato said.
CSL Behring said it will begin onshore development of a plasma-based SARS-CoV-2 plasma product immediately. The product will concentrate antibodies from plasma donated by Australian people who have recovered from the disease. The CSL unit is part of a global plasma therapy alliance with Takeda and others. Story
Biotech CEOs from Cadent Therapeutics, 28-7, Surface Oncology and others mostly in the Boston area have joined a forum that gathers for a weekly call to exchange ideas for managing the COVID-19 crisis, The Wall Street Journal reported.
Scientists have identified a new strain of the coronavirus that appears to be more contagious than the early versions in the pandemic, according to a new study led by scientists at Los Alamos National Laboratory.
UPDATED: Tuesday, May 5 at 3:13 p.m. ET
Rick Bright, former head of the HHS‘ BARDA unit, filed a complaint alleging his transfer away from his position was retaliation for his criticism of the Trump administration’s COVID-19 response. Story
Meanwhile, the White House is planning to wind down the coronavirus task force „in the coming weeks,“ the New York Times reports.
Immigration and Customs Enforcement is working with companies such as Pfizer and Amazon to crack down on counterfeit medical gear and COVID-19 tests, the Wall Street Journal reports.
UPDATED: Tuesday, May 5 at 8:55 a.m. ET
Pfizer and partner BioNTech started human testing for their mRNA vaccine program in the U.S. shortly after starting trial enrollment in Germany.
A drugmaker in Bangladesh, Beximco, plans to start making Gilead’s newly FDA-authorized remdesivir for $59 to $71 per vial, Reuters reports. The company is planning to produce the drug for domestic use, at least initially. It isn’t clear whether Beximco had a licensing deal to manufacture the product.
One aspiration for Johnson & Johnson’s manufacturing deal with Emergent BioSolutions was to have the potential vaccine produced stateside, the New York Times reports. The R&D work, partially funded by BARDA, is taking place at a J&J lab in the Netherlands.
Amid scientific progress for COVID-19 drugs, tests and vaccines, experts still believe vaccine timelines are overly optimistic, CNBC reports.
Among other gatherings, Biogen’s Boston meeting in late February played a „notable“ role in the early COVID-19 outbreak in the U.S., a top CDC official said. The management confab spawned cases in several states and overseas.
NIAID chief Anthony Fauci told National Geographic there’s no evidence the novel coronavirus was manipulated in a lab. Trump administration officials have been ramping up their criticism of the Chinese government’s handling of the outbreak.
As states around the country start to reopen their economies, the influential IHME model from the University of Washington dramatically raised its COVID-19 death projection to more than 134,000 by August 4. And the New York Times obtained a CDC document that shows a projection for about 3,000 daily deaths by early June, nearly double the current level.
Drug companies are testing dozens of existing drugs against COVID-19, and now a supercomputer says hepatitis C drugs might hold promise, Economic Times reports.
As lawmakers look into the Trump administration’s pandemic response, the administration has barred task force members from appearing at Congressional hearings during the month of May, the Wall Street Journal reports.
China already has four companies testing potential COVID-19 vaccines in humans, but as the New York Times points out, the country’s vaccine industry has suffered scandals in recent years.
UPDATED: Monday, May 4 at 3:25 p.m. ET
How much should Gilead Sciences charge for remdesivir? Up to $4,460 per patient, according to the Institute for Clinical and Economic Review. But even at $1,000 per patient—less than a quarter of ICER’s pitched price—Gilead could theoretically rake in $1 billion in sales, as it looks to build a supply capable of treating 1 million patients by the end of the year. Story
And now that remdesivir has the FDA’s blessing, analysts are already turning to what’s next—with some saying the antiviral is just the first of several drugs expected to treat COVID-19. Others may include convalescent plasma and concentrated antibody therapies, which may carry stronger benefits, but face supply challenges. Story
Alnylam and Vir Biotechnology identified an inhaled RNAi treatment for COVID-19, and are aiming to begin human testing before the end of the year. Their collaborative efforts launched in early March, after Alnylam synthesized 350 siRNAs targeting the SARS-CoV-2 genome, and Vir signed up to assess the antiviral activity of the most promising prospects. Story
Shortly after scoring an emergency authorization for its COVID-19 antibody diagnostic, Roche said it would invest $459 million into a German manufacturing facility to help meet its goals of producing tens of millions of tests per month. Story
The CDC launched a wide-ranging nationwide consortium—including dozens of state and federal labs, the private sector, academia, and non-profits—to coordinate future whole genome sequencing efforts aimed at the novel coronavirus. Public data from the SPHERES project will be used in COVID-19 surveillance and biomedical research. Story
UPDATED: Monday, May 4 at 9:30 a.m. ET
Gilead’s closely-watched remdesivir has secured an FDA emergency use authorization. In the agency’s approval letter, FDA chief scientist Denise Hinton said the lethal nature of COVID-19 and the lack of approved treatments, plus the drug’s promising clinical data, mean that the drug’s potential benefits outweigh potential risks. Story
Eli Lilly is shelling out $10 million up front and committing $245 million in potential milestone payments to license ex-China rights to Junshi Biosciences‘ neutralizing antibody candidate, JS016, according to a disclosure (PDF) to the Hong Kong Stock Exchange. The Chinese biotech is co-developing the therapy with the Institute of Microbiology of the Chinese Academy of Sciences. Lilly and Junshi expect to enter clinical studies in the U.S. in the second quarter.
Besides, Lilly also has an antibody deal with AbCellera, which is now entitled to receive up to $175.6 million from the government of Canada to support drug R&D efforts against COVID-19 as well as future pandemic threats. Story
The FDA has granted an emergency nod to Roche’s antibody test. The company said it has already begun shipping the Elecsys diagnostic kits and plans to ramp up production to the “high double-digit millions per month” in May for the U.S. market and abroad. Story
Meanwhile, convalescent plasma from recovered patients represents another promising approach against COVID-19. The FDA released guidance on the administration and study of such therapies.
Alkermes is accepting applications for its COVID-19 Relief Fund, promising to provide up to $500,000 in grants to assist nonprofit organizations in their work to help address COVID-19-related needs for people living with addiction, serious mental illness or cancer.
NASA has applied its space-based skills on Earth, having received an FDA emergency authorization for VITAL (Ventilator Intervention Technology Accessible Locallyits), a ventilator designed for the pandemic. Story
Meanwhile, U.S. weapons makers have teamed up with medical device companies to increase the supply of ventilators, Reuters reported. As part of a wider collaboration, the Aerospace Industries Association teamed with U.S. medical device trade association AdvaMed to create a marketplace where ventilator makers post requests to defense companies to help meet surging demand.
The European Union warned that suspension of childhood vaccination during the coronavirus epidemic could cause serious problems, Reuters reported.
President Donald Trump now says he believes the U.S. death toll from the pandemic could reach as many as 100,000. But he said he’s confident a vaccine would be developed by year-end.
UPDATED: Friday, May 1 at 3 p.m. ET
The mechanism of action Roche’s IL-6 inhibitor Actemra, which has posted early effective data in treating cytokine storm in severe COVID-19 patients, may be tied to the activation of T-cell counts in patients‘ blood, a new study found. Story
The National Institutes of Health kicked off what it describes as a “Shark Tank”-like effort to select and fund new diagnostic tests for the novel coronavirus, and its offering a total of $1.5 billion to be divvied up among the winners. Story
Citron Research has come out against Inovio, labeling the biotech’s COVID-19 vaccine claims as Theranos-like, the medtech company that promised to deliver answers and diagnoses for many diseases through a simple blood test but turned out to be a sham. The firm’s attack claimed that Inovio developed a vaccine in just three hours “under the same scientific team that has spent decades deceiving investors.” Story
Complications from the novel coronavirus pandemic have sent the cost of transporting drugs up 224%, according to a new survey from a generics industry trade association. Story
Federal prosecutors have launched a probe into the communications of Vladimir „Zav“ Zelenko, a doctor who has discussed the efficacy of antimalarial hydroxychloroquine with the White House, the Washington Post reported. The probe began after Jerome Corsi, long attached to former Trump associate Roger Stone, accidentally emailed communications to a federal prosecutor rather than Zelenko.
UPDATED: Friday, May 1 at 9:30 a.m. ET
The NIH’s National Institute of Allergy and Infectious Diseases is already running separate studies on Gilead Sciences‘ antiviral remdeisivr and Eli Lilly’s anti-inflammatory drug Olumiant. Now, the institution is planning to combine the two drugs in another study, Gilead said during a presentation on Thursday. The exact trial design, including the number of patients to be enrolled, is unclear, but Gilead said the study will „start soon.“
During the presentation, Gilead CEO Daniel O’Day said recent remdesivir data coming out of NIAID could serve as a benchmark for future drug development efforts. The results „changes the landscape for drug development within COVID-19 in that one has to now think about comparing to remdesivir and/or looking at adding to remdesivir,“ he said. Story
Meanwhile, investors are more interested in knowing whether or when remdesivir can make money. When pressed by analysts on the Thursday conference call about a commercial plan, O’Day said, „we just don’t have the answers yet.“ So far, the biotech has earmarked its entire supply through this summer, prioritizing clinical trials and compassionate use programs. Story
To speed up its evaluation, the European Medicines Agency started a rolling review of remdesivir, though the agency has yet to commit to a timetable. Japanese Prime Minister Shinzo Abe previously said remdesivir will enjoy a fast-track review in his country as soon as Gilead files an application. Story
Amgen will test its newly-acquired blockbuster psoriasis med Otezla as a potential COVID-19 treatment, joining several other companies studying whether a drug’s anti-inflammatory traits can fight the new disease. Amgen bought Otezla from Celgene in a $13.4 billion deal late last year as part of Celgene’s merger with Bristol Myers Squibb.
Moderna Therapeutics has tapped Lonza to help manufacture the biotech’s mRNA vaccine candidate, dubbed mRNA-1273. The agreement will initially bring suites online at Lonza facilities in the U.S. and Switzerland, with batch production expected to start at the U.S. site as early as July. If everything goes as planned, Moderna could have the capacity to produce one billion doses a year. Story
The FDA published guidance for the industry on exemptions from certain requirements of the Drug Supply Chain Security Act during the pandemic. Some activities such as tracing drugs through distribution channels are waived when a product is for emergency use.
The U.S. Intelligence Community, which is made up of several government intelligence agencies, has concluded that the novel coronavirus was not man-made or genetically modified in a lab. The agencies „will continue to rigorously examine emerging information and intelligence to determine whether the outbreak began through contact with infected animals or if it was the result of an accident at a laboratory in Wuhan,” it added.
Hologic is launching a second COVID-19 test that can dramatically expand diagnostic capabilities in the U.S. The company will distribute three million tests to around 1,000 hospitals and public health labs starting from next week.
UPDATED: Thursday, April 30 at 3 p.m. ET
Fujifilm Diosynth Biotechnologies has set aside space at its Denmark biologics facility for a to-be-determined COVID-19 treatment identified through the Bill Gates-funded therapeutics accelerator. The deal sets aside an unspecified production volume for 2021 with options for the following years, Fujifilm said. Story
The Trump administration is working up a Manhattan Project-style joint initiative dubbed „Operation Warp Speed“ to bring biotech, pharma and federal agencies together to speed up the hunt for a COVID-19 vaccine. The project’s goal is delivering 100 million doses of a viable COVID-19 vaccine by the end of the year, which would be a radical acceleration of the typical vaccine development timeline, which is typically described in years, not months. Story
Seeking to explain why new, positive data on Gilead Sciences‘ remdesivir were released at a White House press briefing rather than through normal channels, Anthony Fauci, M.D., director of the National Institutes of Health, told Reuters the move was intended to preempt leaks that could confuse the narrative. Story
Scientists from the University of Texas at Austin, the National Institutes of Health, and Ghent University in Belgium developed a treatment that links two nanobodies isolated from a llama to create an antibody that binds to the spike protein on the coronavirus that causes COVID-19. Story
Riding a sales wave for triple combo cystic fibrosis drug Trikafta, Vertex is one of the rare drugmakers upping its sales forecast despite operational hits from the novel coronavirus pandemic. The drugmaker said it grew 77% on the quarter. Story
UPDATED: Thursday, April 30 at 9:25 a.m. ET
AstraZeneca agreed to help develop and manufacture an experimental recombinant adenovirus vaccine developed by Oxford University, joining a heated race to make an effective shot against the novel coronavirus. The company aims to build capacity to produce 100 million doses by the end of the year, CEO Pascal Soriot told The Financial Times. The company says the partners should have an idea of the vaccine’s potential efficacy by July. Story
After assessing 19 existing drugs, an expert panel convened by the Indian government ranked Fujifilm’s Avigan and Roche’s Actemra as showing the most promise in terms of readiness and potential to fight the disease in the country, Times of India reported. The task force also said more clinical trial results are needed before these two drugs‘ potential can truly be determined.
Meanwhile, India’s Glenmark Pharmaceuticals said it won regulatory clearance to run a local clinical trial of its generic version of Avigan, or favipiravir, on mild-to-moderate COVID-19 patients. The trial, the first for a novel coronavirus therapy in India, will enroll 150 patients.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research—which is responsible for reviewing vaccines—has emerged as the Trump Administration’s unofficial vaccine czar, according to Politico. He’s reportedly been acting as the HHS‘ informal adviser in cross-agency collaborations with the NIH and the Biomedical Advanced Research and Development Authority.
At the same time, Senate Democrats are pressing HHS Secretay Alex Azar for explanations about former BARDA chief Rick Bright’s recent reassignment. Bright has alleged that he was ousted after resisting pressure to funnel cash toward the old anti-malaria drug hydroxychloroquine, which President Trump had backed publicly as a COVID-19 „game changer.“
Some parts of New Jersey are offering a saliva-based test developed by a Rutgers University lab. It avoids the discomfort associated with the use of a long swab in other tests and could be less risky for healthcare workers.
UPDATED: Wednesday, April 29 at 3:15 p.m. ET
After Gilead Sciences released word that new remdesivir trial data had turned up positive, the wait for details began. Further stoking enthusiasm, NIAID director Anthony Fauci at midday hailed the drug as real progress against the virus.
By midafternoon, the details had arrived. Remdesivir cut recovery time for hospitalized COVID-19 patients by four days, or 31%, in a National Institutes of Health-sponsored study pitting the drug against placebo in more than 1,000 patients. Story
In vaccine territory, the White House is said to be working on “Operation Warp Speed,“ a project that aims to deliver 100 million doses of a viable COVID-19 vaccine by the end of the year, according to Bloomberg. It would be a radical acceleration of the typical vaccine development timeline, typically described in years, not months. Story
Pfizer and BioNTech have taken another step forward with their potential COVID-19 vaccine. The biotech-pharma partners said they’ve finished dosing the first cohort in their phase 1/2 clinical trial. The first round, which took place in Germany, wrapped up just a week after the companies won the all-clear to run trials in the country. Story
Despite hiccups in clinical testing due to COVID-19, AstraZeneca thinks its late-stage pipeline will emerge from the pandemic largely unscathed. The company’s phase 3 pipeline currently features seven programs, most of which are testing cocktails involving anti-PD-L1 antibody Imfinzi and CTLA-4 prospect tremelimumab. Story
UPDATED: Wednesday, April 29 at 8:48 a.m. ET
Gilead’s remdesivir met its primary endpoint in a study conducted by the National Institute of Allergy and Infectious Diseases, the drugmaker reports. NIAID plans to provide more details at an upcoming briefing. Analysts with Jefferies believe the drug will secure some type of FDA approval.
For his part, Former FDA commissioner Scott Gottlieb told Stat the drug could be „part of a toolbox“ of drugs and tests to help with the COVID-19 response.
Johnson & Johnson has inked another vaccine manufacturing partnership, this time with Catalent. The pharma giant previously reached its first deal with Emergent BioSolutions. Story
GlaxoSmithKline warned that despite its strong performance so far, the pandemic is a „very dynamic and uncertain situation“ and risks remain throughout the year. Those risks include manufacturing and clinical trial disruptions, limits to patient access and more. Story
Japan’s Shionogi is among the biopharma companies involved in COVID-19 R&D work, with programs in drugs and vaccines.
Alkermes withdrew its 2020 guidance due to the pandemic.
Authorities in France are cracking down on foreign investment in companies that might be vulnerable to takeovers due to the pandemic.
Australia is calling for an investigation into China’s handling of the early stages of the COVID-19 outbreak.
UPDATED: Tuesday, April 28 at 3:03 p.m. ET
Pfizer CEO Albert Bourla told The Wall Street Journal the company’s COVID-19 vaccine could be ready for emergency distribution by the fall. The company could further be ready for a broader rollout by the end of the year, he added.
Meanwhile, Pfizer is also bracing for a second-quarter sales hit as its reps are sidelined.
Merck is expecting a multibillion-dollar hit to 2020 sales from COVID-19 as the company has a heavy presence in physician-administered drugs—including its star cancer therapy Keytruda.
Researchers around the world are working to advance COVID-19 drug candidates, but a team at Oxford University’s Jenner Institute got going with a head start and plans to kick off a 6,000-participant trial next month, The New York Times reports. The team is working with drug manufacturers in Europe and Asia to quickly produce up to 1 billion doses upon a potential approval.
Serum Institute of India is one drugmaker engaged in the project. The Indian vaccine giant is aiming to produce 40 million doses by September or October, Business Insider reports.
Novartis is planning to study canakinumab, which is approved as the rare-disease drug Ilaris, in patients with COVID-19. Investigators aim to study whether the drug can treat cytokine release syndrome, a severe immune overreaction.
Sen. Elizabeth Warren and Rep. Alexandria Ocasio-Cortez proposed a ban on large company mergers during the pandemic, NBC News reports.
After a lockdown to slow the spread of COVID-19, India’s pharma production hub of Baddi is back online. Supply chain concerns still remain. Story
Novartis‘ new wet age-related macular degeneration drug Beovu has suffered from a safety alert and the COVID-19 pandemic, but execs still see blockbuster potential for the drug. Story
Even as manufacturing in China has resumed, the consumer economy hasn’t yet recovered, the New York Times reports.
Amid the pandemic, the U.S. food supply chain has held up, but outbreaks at food processing plants have started to raise alarm.
UPDATED: Monday, April 27 at 11 a.m. ET
Sanofi and Regeneron will scale back a phase 3 study of IL-6 inhibitor Kevzara to treat COVID-19 after early results in a precursor study revealed disappointing results in severely ill patients. The drugmakers said the U.S. study will now include only critically ill patients treated with a 400-milligram higher dose of the drug. Story
Despite a lack of clinical proof of its efficacy in COVID-19, Gilead Sciences‘ highly touted investigational candidate remdesivir may score an early approval in Japan. Prime Minister Shinzo Abe reportedly said the drug could be fast-tracked for approval despite mixed early clinical data. Story
Speaking of remdesivir’s mixed results, a new Chinese study has found the drug may be associated with lower sperm counts in test mice, Bloomberg reported.
Meanwhile, Roche’s IL-6 inhibitor Actemra reportedly posted a win in an early French trial in treating cytokine storm in severe and critically ill COVID-19 patients with pneumonia.
Former FDA Commissioner Scott Gottlieb told CBS‘ Face the Nation on Sunday that doctors should not prescribe antimalarial hydroxychloroquine––a favorite of President Donald Trump––because clinical tests have shown little efficacy in COVID-19 and the drug carries possible safety hazards, too, particularly in combination with antibiotic azithromycin.
Gottlieb also blasted the Trump administration’s decision to reassign former BARDA chief Rick Bright, saying the decision—possibly motivated by politics—would leave „uncertainty“ about the federal government’s leadership in finding a COVID-19 vaccine.
New York hospitals have reportedly begun testing antacid Pepcid as a possible treatment for COVID-19, the Daily Mail reported. The tentative testing follows positive anecdotal evidence out of China, and physicians are hoping to release results in a few weeks.
Merck & Co. and the Institute for Systems Biology announced a new collaboration to investigate and define the molecular mechanisms of the novel coronavirus and COVID-19, and identify targets for medicines and vaccines, the drugmaker said Monday.
As states begin to reopen businesses to restart their economies, Republican Ohio Gov. Mike DeWine has planned to drastically expand the state’s coronavirus testing. DeWine said the state had reached a deal with ThermoFisher Scientific to boost access to testing reagents.
A House Democrat is pushing for a ban on corporate mergers until the end of the novel coronavirus pandemic, hoping to stanch a potential flood of big corporate buyouts of struggling businesses, Reuters reported. Rhode Island Rep. David Cicilline proposed banning transactions involving companies that weren’t already in bankruptcy proceedings.
New York Sen. Chuck Schumer, a Democrat, is calling for an FDA crackdown on unregulated coronavirus testing kits after a swath of companies have begun marketing the untested kits to U.S. consumers.
Meanwhile, the FDA authorized three new coronavirus antibody testing kits, which are designed to determine whether individuals have already contracted the virus.
A pharma manufacturing hub in Baddi, India, has reportedly been reopened after the Indian government locked down the area as a „containment zone“ earlier this month.
UPDATED: Friday, April 24 at 3:15 p.m. ET
Gilead Sciences is hoping a study of investigational candidate remdesivir, begun in February by the National Institute of Allergy and Infectious Diseases, will read out earlier than expected, Reuters reported. A recent trial in China showed no clinical benefit from the drug, though, as Gilead pointed out, the study ended early due to low enrollment.
World leaders––with the notable absence of the United States––pledged Friday to pool resources to help find a therapeutic or vaccine for COVID-19 in a World Health Organization joint effort.
UPDATED: Friday, April 24 at 9:00 a.m. ET
At Thursday’s White House press briefing, President Donald Trump said researchers should look into whether ultraviolet light or disinfectant injections could kill COVID-19 in patients, prompting strong pushback. A spokesman for Lysol’s parent company said that „under no circumstance should our disinfectant products be administered into the human body (through injection, ingestion or any other route).“
Appearing on CNN later, FDA commissioner Stephen Hahn said that disinfectant should not be injected into patients.
Sanofi CEO Paul Hudson said that the most complex component of a COVID-19 vaccine rollout will be delivering on manufacturing. The Sanofi/GlaxoSmithKline partnership is the primary group he sees as able to meet demand. Story
Meanwhile, Johnson & Johnson teamed with Emergent BioSolutions in the first of several expected deals to build capacity for its potential vaccine. J&J aims to supply more than 1 billion doses globally. Story
After the World Health Organization leaked a trial miss for Gilead’s remdesivir in China on its website, a spokesperson for the drugmaker—plus analysts—said there was more to the story. Story
Chinese vaccine biotech Sinovac secured a loan and land as it works on a COVID-19 prospect. Story
After early hype from Trump and others for hydroxychloroquine, the FDA now says it’s heard reports of dangerous side effects. The agency only recommends the drug be used in hospitalized patients. Story
Rep. David Cicilline called for a pause on mergers during the pandemic so large companies can’t buy out struggling smaller competitors.
Market caps for 20 large biopharma companies fell by a combined $2.6 trillion during the first quarter, according to GlobalData. Story
UPDATED: Thursday, April 23 at 2:30 p.m. ET
Early data from a 237-patient randomized trial of Gilead Sciences‘ remdesivir in China––released by accident––reportedly showed no clinical benefit for patients with COVID-19, but the drugmaker has pushed back against that characterization and called the results „inconclusive.“
Big Pharma’s pursuit of therapeutics and vaccines for COVID-19 could give the industry a „once in a generation“ opportunity rehab its tarnished public image, Eli Lilly CEO David Ricks told analysts in a first-quarter earnings call Thursday. Story
Pfizer and Teva have posted shortages of antibiotic azithromycin, which has been touted as a potential therapy for COVID-19 in combination with antimalarial hydroxychloroquine. Story
As hospitals redirect resources toward COVID-19 and patients put off less-urgent medical procedures and trips to the doctor, Medtronic has seen a serious impact on its bottom line—including a 60% drop in weekly revenue from the U.S., where the medtech giant does most of its business. Story
Icon is cutting costs drastically after 65% of its clinical trial sites have been affected by the novel coronavirus, the company said. Story
Researchers are beginning to take a hard look at using CAR-T therapy and engineered immune cells to combat the novel coronavirus. Based on previous research, Antonio Bertoletti from Duke-NUS Medical School’s emerging infectious diseases research program suggests these immunotherapies might also be useful in treating SARS-CoV-2. Story
Researchers are turning their interest to blood pressure medicines after 72% of COVID-19-diagnosed patients age 65 and older presented hypertension, according to a Centers for Disease Control and Prevention report.
A screening of 3,000 New York people found 14% with novel coronavirus antibodies, indicating that up to 2.7 million of the state’s residents may have already been infected with the virus, Reuters reported.
UPDATED: Thursday, April 23 at 8:38 a.m. ET
Rick Bright, a vaccine expert and BARDA director who was reassigned to NIH this week, issued a statement saying his transfer was due to his questioning of drugs and vaccines that „lack scientific merit.“ Science, not „politics or cronyism,“ has to lead the COVID-19 fight, he said, and pledged to call in the HHS inspector general to investigate. Story
Eli Lilly saw a $250 million benefit to first-quarter sales from increased medicine purchasing amid the pandemic.
AstraZeneca and Saint Luke’s Mid America Heart Institute are starting a global phase 3 trial of type 2 diabetes drug Farxiga in patients hospitalized with COVID-19. Story
Moderna vaccine phase 1 trial participants are set to receive another round of shots, indicating that the trial is on track so far, USA Today reports.
Valneva and Dynavax are teaming up to work on a COVID-19 vaccine prospect.
Research from Northeastern University says COVID-19 began spreading in U.S. cities much earlier than previously understood.
Judges are reporting a much lower level of court activity due to the pandemic, so the National Judicial College is starting a formal study on the topic, Law360 reports.
UPDATED: Wednesday, April 22 at 3:52 p.m. ET
Though Roche has appeared steady during the COVID-19 crisis, executives still warn of volatilities below the surface. Sales of Actemra jumped 30% in the first quarter, as interest grew in its use against the coronavirus’ immune complications. And while Ocrevus saw 38% growth, that’s down from last year’s 57%, due to multiple sclerosis patients delaying physician visits. Story
Meanwhile, Biogen—perhaps the most intimately affected drugmaker during this pandemic—has faced both unexpected demand and dosing delays for its top drugs. It pulled in about $100 million in sales as people rushed to secure treatment ahead of lockdowns, but it also expects to see future volatility, as some of its infusions still require a doctor present. Story
COVID-19 is also threatening to put the brakes on the fast-growing market for ATTR cardiomyopathy drugs—including Pfizer’s Vyndaqel, approved last year. While the halt may be temporary, investors say it’s enough to change near-term sales forecasts. Story
And to keep clinical trials going, PPD’s Accelerated Enrollment Solutions network set up a new program to transfer patients from study sites hit by the pandemic to other research facilities. Story
UPDATED: Wednesday, April 22 at 11:22 a.m. ET
Abbott Labs warned that its rapid COVID-19 testing device can produce false negatives if samples aren’t handled properly. Healthcare providers shouldn’t use „viral transport media“ to transport or store them, the company said.
As Roche works to launch its own antibody test, CEO Severin Schwan called current antibody testing a „disaster.“ In a scathing assessment, Schwan said many of the tests are „not worth anything, or have very little use“ and that he could make a better one „overnight in a garage.“ Story
Pfizer and its vaccine partner BioNTech scored approval from German authorities to start a phase 2 trial of their mRNA candidate. A U.S. trial is also expected to begin „shortly.“ Story
Dozens of manufacturing plants in a key drug-producing region in India have shut down, raising supply chain concerns. Story
Dr. Rick Bright, the leader of a federal agency in charge of working with biopharma companies to develop vaccines, drugs and diagnostics, is no longer with that agency. Story
The National Institutes of Health released COVID-19 treatment guidelines that outline how little progress has been made in drug research so far, NYT reports.
Officials in California released details of early COVID-19 deaths that preceded the United States‘ first confirmed death, the New York Times reports. The victims hadn’t traveled, meaning the virus had been spreading in the U.S. earlier than thought.
And even as the U.S. deals with tens of thousands of COVID-19 deaths and more than 800,000 cases, CDC director Robert Redfield said a second wave next winter could be „even more difficult.“
UPDATED: Tuesday, April 21 at 3:21 p.m. ET
A VA study of hydroxychloroquine, with or without azithromycin, “found no evidence” that the drug reduced the risk of mechanical ventilation in veterans hospitalized with COVID-19.
The FDA has approved an at-home testing kit from LabCorp. The kit requires people to send samples into labs for processing. Story
Pharma’s reputation has soared amid the pandemic, with 40% of survey respondents reporting that their view of the industry has improved since the crisis began. Story
Many in the public have heard the vaccine development estimates of 12 to 18 months, but that’s unrealistic, an analyst says. Story
Big Pharma companies don’t want to go it alone in spending on COVID-19 R&D programs, several executives told the Financial Times. They’re looking for governments to spend billions to aid the programs. Story
UPDATED: Tuesday, April 21 at 9:40 a.m. ET
Pharma CEOs are asking that governments pour out billions of dollars in advance for the development and production of potential COVID-19 drugs. “If industry does not know if there will be a market in 18 months, [it] cannot carry all [the costs]. Industry alone can’t provide all the investment needed now for billions of doses,” David Loew, executive vice president of Sanofi Pasteur, told the Financial Times. “Society will have to finance this huge investment. My fear is the same as after the [2009 swine] flu pandemic, when everybody loses interest,” Takeda CEO Christophe Weber said. Story
A vaccine won’t be available for general use for about three years, rather than the 18 months the National Institutes of Health has suggested, SVB Leerink analyst Geoffrey Porges says. „We view the current expectations for a vaccine in this timeframe as the equivalent of standing 24 feet (the usual distance is 8 feet) from a dartboard, with one dart in hand, and counting on a bullseye from one throw,“ Porges wrote in a Tuesday investor note.
Following other companies such as Pfizer and Novo Nordisk, Merck & Co. is now also expanding its patient assistance program, allowing eligible patients to get its medicines at no cost.
To ease shortages of drugs for COVID-19 patients who are on ventilators, the FDA is now allowing small compound pharmacies to temporarily fill the supply gap.
Japanese biotech Takara Bio’s CEO Koichi Nakao told Nikkei his company plans to mass produce novel coronavirus vaccines as early as this year.
Cipla is committing INR 25 crore ($3.25 million) to support the Indian government’s efforts to effectively combat the COVID-19 pandemic.
Meanwhile, the United Nations General Assembly passed a resolution Monday calling for an international collaboration to ensure rapid development, manufacturing and equitable access to medicine, vaccines and medical equipment.
About 4.1% of 863 adults tested positive for coronavirus antibodies in a study in Los Angeles, suggesting these people have been exposed to the pathogen even though some may not show symptoms, Reuters reported. This suggests the rate of infection may be 40 times higher than the number of confirmed cases.
President Donald Trump said he plans to sign an executive order temporarily suspending immigration into the U.S., saying he’s trying to protect American jobs amid the economic blow caused by the pandemic. Administration officials said the order wouldn’t change the status quo, as the administration has already halted processing nearly every immigration form.
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