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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Following a court’s ruling last week over a partial clinical hold placed on the company in 2018 by the U.S. Food and Drug Administration, Vanda Pharmaceuticals said it is undertaking a “comprehensive review” of the decision and will then determine the next appropriate steps.
The active component of the drug, sodium valproate, has been on the market for epilepsy and bipolar disorder since 1967.
MedAlliance has announced the award of its first CE Mark approval: for SELUTION SLR™, a novel Sirolimus Drug Eluting Balloon, for the treatment of peripheral arterial disease.
GBA Group Pharma has informed its industry partners and clients on risks to their clinical trial plans caused by Brexit and is highlighting the significant business difficulties for healthcare companies running clinical trials through UK-based organisations.
Audenz is the first-ever adjuvanted, cell-based influenza vaccine designed to protect against influenza A (H5N1) in the event of a pandemic.
The spreading of the coronavirus that began in Wuhan, China has researchers and health officials worldwide studying the emerging virus and preparing to treat it and develop vaccines. With such an enormous global focus, it seems that new information about the virus and the infection is being published each day.
The focus of the research will be to learn more about ApoE4 and how and why it affects Alzheimer’s disease.
The study notes that about half of recent drug approvals were built on a single pivotal clinical trial. Typically, two pivotal, Phase III trials were the norm.
The U.S. Department of Justice has leveled more charges against members of the U.S. science community who have alleged ties to China.
In the complaint, the FTC alleged an “elaborate anticompetitive scheme to preserve a monopoly” on Daraprim.