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.
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The National Institute of Allergy & Infectious Diseases (NIAID) has founded a new clinical trials network focused on enrolling volunteers in clinical trials for COVID-19 vaccines and monoclonal antibodies.
The submission was completed with ongoing collaboration with the FDA and include data from the Phase III EMERGE and ENGAGE trials, as well as the Phase Ib PRIME study. Biogen has also requested Priority Review.
On Tuesday, the White House notified Congress and the United Nations of the decision. However, the withdrawal will not be immediate.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 8, 2020.
This deal with BARDA and the DoD supports continuing the manufacturing in order for it to be immediately available in the U.S. if the clinical trials are successful.
Novavax said the funding will allow the company to participate in Operation Warp Speed, the government’s program that has a goal of supporting the development of hundreds of millions of vaccine doses by 2021.
Cellectis, based in Paris and New York, announced that the U.S. Food and Drug Administration (FDA) had placed a clinical hold on its MELANI-01 trial.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 6, 2020.
It’s a relatively slow month ahead for July in terms of PDUFA dates for the U.S. FDA. However, there are several dates pending throughout the month. Here’s a look at three for the next two weeks.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 3, 2020.