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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.
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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.
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Lilly said it is cooperating fully with the DOJ and is in the process of conducting its own investigation into the allegations made against the company.
When the pandemic hit, many companies diverted resources aimed at HIV to COVID-19, which ended up pausing some research efforts.
Ocugen submitted a “Master File” to the U.S. FDA for COVAXIN, the vaccine that has already received authorization in India for people ages 12 and above.
LION-101 is a novel recombinant AAV being developed as a one-time intravenous infusion for the treatment of adult and adolescent patients with Limb-Girdle Muscular Dystrophy Type 2I/R9.
The UK’s Competition and Markets Authority (CMA) will determine if the deal is anti-competitive.
The White House has also called for an independent investigation and more information from China about the pandemic’s origins.
Please check out the biopharma industry’s COVID-19 stories that are trending for May 25, 2021.
The disclosure comes the day before the WHO is expected to plan for the next phase of investigations into the origins of COVID-19.
It’s a busy week for the U.S. Food and Drug Administration, with a number of drug approvals on the calendar and an advisory committee meeting. Read on for more information.
The House Select Subcommittee on the Coronavirus Crisis questioned executives from Emergent BioSolutions as part of a congressional probe.