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.
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 FDA is set to decide on a Humira biosimilar and hold an Adcomm meeting for an Alzheimer’s agitation treatment. Also on its calendar for April are decision dates for two vaccine hopefuls.
After 12 years on the market, the FDA announced it has withdrawn its previous approval for the only drug on the market to prevent preterm birth, Covis Pharma’s Makena.
Farallon Capital Management is waging a proxy battle with Exelixis over R&D spending. The hedge fund issued a letter to the company’s board of directors on Wednesday.
NLRB General Counsel Jennifer Abruzzo issued a memo to all field offices clarifying the board’s recent ruling in a case regarding severance agreements.
The Inflation Reduction Act contains provisions designed to influence drug prices. These policies might affect drug development and the prioritization of new drugs.
Gossamer Bio announced Monday that it is discontinuing the development of its lymphoma candidate, GB5121, following two patient deaths in the Phase Ib/II STAR-CNS study.
HUTCHMED has completed the rolling submission of its New Drug Application to the FDA for fruquintinib, its candidate for refractor metastatic colorectal cancer.
A federal court sided in favor of Vanda Pharmaceuticals in its Freedom of Information Act case against the FDA regarding the CRL for its sleep drug label expansion.
In an earnings call Wednesday, bluebird bio revealed it is unlikely to meet its first-quarter goal to submit a Biologics License Application for sickle cell disease (SCD) gene therapy lovo-cel.
Citing reports of “alarming toxicity” among other accusations, short-seller Scorpion Capital will file a Citizen’s Petition with the FDA to have its approval of Wakix withdrawn.