Policy
Clene disclosed Thursday the FDA has determined that biomarker Neurofilament Light Chain reduction in its Phase II programs “were insufficient to support accelerated approval at this time.”
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Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
Having seen Congress spend money to onshore semiconductor production, pharma groups are pushing for similar incentives for domestic drug manufacturing.
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In an open letter published Monday, more than 480 biopharma industry leaders expressed their support for the FDA after a Texas federal judge ruled to hold the approval of the abortion pill mifepristone.
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After 12 years on the market, the FDA announced it has withdrawn its previous approval for the only drug on the market to prevent preterm birth, Covis Pharma’s Makena.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.