Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for December 8, 2020.
Due to the registration potential of the mid-stage studies, the U.S. Food and Drug Administration requested the company complete a standard safety study, which amounts to a partial clinical hold on the study.
Governments across the globe have flexed their financial muscles to secure promises of as many doses of COVID-19 vaccines as possible when they become available.
Check out some news happening today around the biopharma industry.
As if attempting to steal hard-won research wasn’t bad enough, hackers are now hitting people where it really hurts – with e-documents containing malicious code embedded in false offers of employment.
Yesterday, the United Kingdom’s MHRA granted temporary authorization for emergency use to Pfizer and BioNTech for their COVID-19 mRNA vaccine. It didn’t take long for the decision to generate criticism and questions.
the robustness and independence of FDA review – even under an EUA – is an important factor in encouraging a skeptical public to accept COVID-19 vaccinations.
The U.S. Food and Drug Administration has given Emergency Use Authorization (EUA) to a COVID-19 test developed by Roche that measures antibodies within the blood.
On Tuesday, the CDC Advisory Committee on Immunization Practices voted 13-1 in support of this recommendation.
The United Kingdom’s Medicines & Healthcare Products Regulatory Agency granted temporary authorization for emergency use to Pfizer and BioNTech for their COVID-19 mRNA vaccine, BNT162b2.