Policy
The FDA’s drug review process can often be “unpredictable,” and review teams typically “differ greatly” in what they ask of drug sponsors, Sen. Bill Cassidy said.
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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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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.
Meet with regulatory affairs professionals early and often. That’s the message from Neelu Gibson, VP, regulatory affairs, at BD, speaking at Biocom’s June virtual meeting, “Regulatory Affairs…Engagement Do’s & Don’ts.”
The U.S. Justice Department charged Glenmark Pharmaceuticals, headquartered in India, with conspiring with other generic drug companies to increase and hold prices for the cholesterol drug pravastatin between May 2013 and December 2015.
Bavencio is an anti-PD-L1 checkpoint inhibitor co-developed by Merck KGaA, Darmstadt, German and Pfizer via EMD Serono, a business unit of the two companies.
The FDA guidelines also indicated a vaccine would not be approved unless it had “clearly demonstrated” proof of the vaccine’s safety and effectiveness in a clinical trial.