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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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Tricida plans to request a Type A meeting with the FDA, which is expected to take place in the fourth quarter of this year. This meeting will decide the future of veverimer.
There are several China-based companies that have vaccine candidates in Phase III.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 24, 2020.
According to a report, three people briefed on the plan indicated Trump wants to give AstraZeneca and the University of Oxford’s experimental COVID-19 vaccine emergency use authorization ahead of the U.S. presidential election on November 3.
The U.S. FDA reversed itself Sunday following pressure from the White House and announced an Emergency Use Authorization for convalescent plasma as a treatment for patients who have contracted COVID-19.
August has been a busy month for the U.S. Food and Drug Administration. The final two weeks are marked by a number of PDUFA dates, although a few of those drugs have already been approved.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 21, 2020.
The U.S. FDA placed a hold on the Emergency Use Authorization for convalescent plasma as a potential treatment for COVID-19 over what was described as a lack of robust data supporting its use.
“We are grateful to the NIA for their rigorous scientific review and funding support to advance ALZ-8801 for Alzheimer’s patients in need of an effective treatment,” said Martin Tolar, founder, president and chief executive officer of Alzheon.
The agency indicated that they had completed the review cycle for the application but the application was not ready for approval in its current form.