Policy
Citing the need for more time to review additional Chemistry, Manufacturing and Controls information, the FDA has extended its target action date for Rocket Pharmaceuticals’ investigational gene therapy by three months.
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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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After a series of milestone approvals in the first half of 2023, the FDA is slated to decide on four more firsts before the year’s end.
The U.S. Equal Employment Opportunity Commission settled with Eli Lilly for $2.4 million after filing a suit in September over the company’s recruitment of younger workers.
Citing issues with a third-party contractor, the FDA rejected Regeneron’s regulatory application for a higher-dose regimen of Eylea, the company’s blockbuster eye injection treatment.
An FDA advisory committee voted Wednesday that Ipsen’s fibrodysplasia ossificans progressive candidate palovarotene was effective and the benefits of the drug outweighed its risks.
Recent changes in the board of directors at Biogen has garnered attention due to potential conflicts of interest. Such conflicts vary widely, but one thing is clear: perception matters.
CMS has stated that it will cover new Alzheimer’s drugs if the therapies are fully approved. But significant financial questions remain.
A day after the FDA denied Intercept’s application for its non-alcoholic steatohepatitis treatment, the pharma announced it has axed all NASH investments and one-third of its staff.
Citing anti-trust issues, six states—California, Illinois, Minnesota, New York, Washington and Wisconsin—are joining the FTC’s legal challenge to Amgen’s nearly $27.8 billion buyout of Horizon.
Regeneron envisions new dosing for Eylea’s label and it’s the moment of truth for BioMarin’s gene therapy for hemophilia A. For that and more, see inside.
The government asked a federal judge to overturn a verdict in which a Delaware jury ruled in favor of Gilead, deciding that its preventative HIV drugs Truvada and Descovy did not infringe on its patents.