U.S. Dept. of Health and Human Services (HHS) announced that it formed a new research project agency for health. HHS Secretary Xavier Becerra announced the formal establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the National Institutes of Health (NIH). Adam H. Russell was appointed as acting deputy…
HHS OIG will review FDA’s approval of Biogen’s aducanumab
The HHS Office of Inspector General will review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (TYO:4523). Among the controversies surrounding the drug’s approval is the use of the accelerated approval pathway, which led the agency to use a surrogate endpoint to approve aducanumab conditionally. …
Biden administration invests $3B to accelerate development of next-gen COVID-19 treatments
President Joe Biden’s administration will spend $3 billion in American Rescue Plan money to accelerate the discovery, development and manufacturing of antiviral medicines against COVID-19, HHS announced today. Not only will the Antiviral Program for Pandemics seek to boost the availability of medicines to prevent serious COVID-19 illness and save lives, but it will pursue sustainable…
HHS pauses use of Lilly’s COVID-19 antibody cocktail in several states
The U.S. Department of Health and Human Services (HHS) has recommended pausing the combination of Eli Lilly’s (NYSE:LLY) bamlanivimab/etesevimab in eight states, including Illinois, Massachusetts, Arizona, California, Florida, Indiana, Oregon and Washington. The agency’s reasoning for the decision is grounded in lab data that found the antibody cocktail is not effective against P.1 (Brazilian) or B.1.351…
Pfizer strikes a deal with U.S. government for 100 million additional COVID-19 vaccine doses
This summer, the U.S. government negotiated a deal to acquire 100 million doses of vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) — enough to vaccinate 15% of the population with the two-dose vaccine. The Trump administration passed on an option to acquire an additional 500 million doses. Now that the Pfizer-BioNTech vaccine won emergency use…
HHS confirms involvement in presidential transition process
U.S. Health and Human Services Dept. Secretary Alex Azar confirmed that HHS is working with president-elect Joe Biden on a presidential transition. Speaking during a press briefing, Azar said HHS is in contact with the transition team after the General Services Administration formally recognized Biden as the president-elect, having previously sidestepped questions regarding the potential…
How the U.S. government bolstered Moderna’s COVID-19 vaccine candidate
Until recently, the most rapidly developed vaccine was for mumps, which took four years. Now, Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) appear to be on the cusp of commercializing COVID-19 vaccines under emergency use authorization. It was only a year ago that physicians in China identified unusual pneumonia cases that would later be associated with the novel coronavirus. As impressive…
Moderna and Pfizer COVID-19 vaccines set a high bar for competitors
Moderna (NSDQ:MRNA) is now the second company to release positive preliminary results from a Phase 3 trial of a COVID-19 vaccine candidate — and it appears to be more good news. Last week, Pfizer (NYSE:PFE) announced that early data suggested its BNT162 mRNA-based vaccine was more than 90% effective at reducing symptomatic COVID-19 infections. Today,…
Trump accuses FDA of delaying Pfizer’s COVID-19 vaccine announcement
In the aftermath of Pfizer’s (NYSE: PFE) announcement that its COVID-19 vaccine promises to be 90% effective, President Trump is faulting the FDA for its role allegedly delaying the announcement until after Election Day. The President has pointed to the episode as evidence for a ‘medical deep state,” according to the Washington Post. Already, HHS…
Are Stephen Hahn’s days numbered at FDA?
HHS Secretary Alex Azar has been reportedly discussing the removal of Dr. Stephen Hahn as FDA commissioner, according to Politico. The Politico report cited a half dozen current and former administration officials. FDA spokesperson Michael Felberbaum in an email to Drug Discovery‘s sister site MassDevice denied an Azar-Hahn feud: “Commissioner Hahn enjoys a good relationship…
Report: AstraZeneca Phase III COVID-19 vaccine remains on hold in U.S.
AstraZeneca (NYSE:AZN) is reportedly keeping its COVID-19 vaccine trial in the U.S. on hold as questions remain over patient safety. U.S. Health and Human Services Dept. Secretary Alex Azar told CNBC yesterday that federal investigators are looking for “answers to important questions,” regarding the safety of patients involved in the trial operated by the United Kingdom-based…
Moderna launches Phase 3 study of its COVID-19 vaccine candidate
Moderna (NSDQ:MRNA) announced today that it began dosing participants in the Phase 3 clinical study of its mRNA-1273 COVID-19 vaccine candidate. Cambridge, Mass.-based Moderna’s COVE (coronavirus efficacy) study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research…
HHS taps Pfizer to produce millions of COVID-19 vaccine doses
Two U.S. government agencies today announced an agreement with Pfizer (NYSE:PFE) for production and delivery of 100 million doses of a COVID-19 vaccine. The U.S. Dept. of Health and Human Services, along with the U.S. Defense Dept., agreed to the large-scale production and U.S. delivery deal once Pfizer’s vaccine is successfully manufactured and approved. In addition…
Phlow lands $354m government contract for COVID-19 medications
Phlow announced today that it received $354 million in U.S. government funding to manufacture essential medicines at risk of shortage, including those involved in the COVID-19 pandemic response. Richmond, Va.-based Phlow’s manufacturing is being funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the office of Assistant Secretary for Preparedness and Response…
NIH announces public-private partnership with pharma to coordinate COVID-19 vaccine development
The National Institutes of Health and its foundation announced that, in collaboration with multiple biopharmaceutical companies and government agencies, they will develop an international strategy for coordinating research responses to the COVID-19 pandemic. The collaboration includes the Health and Human Services Office of the Assistant Secretary for Preparedness and Response, the Centers for Disease Control…