Policy
Ahead of a Jan. 31 vote, Senate health committee chair Sen. Bernie Sanders on Thursday said he has the votes needed to subpoena the CEOs of Johnson & Johnson and Merck to testify on drug pricing.
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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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Neurologist David Weisman, with financial ties to the companies, was removed from the FDA’s upcoming advisory committee meeting slated to consider Leqembi’s traditional approval.
The FDA has three high-profile events this week, including one target action date and two advisory committee meetings—one to discuss potential traditional approval for Alzheimer’s drug Leqembi.
The regulator says drug compounders are selling products that falsely claim to contain the same active ingredient, semaglutide, as the blockbuster diabetes and obesity drugs.
The regulator will provide PepGen with a letter within 30 days explaining why a clinical hold was placed on the company’s Phase 1 study of patients with myotonic dystrophy Type 1.
Efforts are underway to fast-track approval for costly gene therapies and make them affordable to a wider patient group via reimbursement through Medicare and Medicaid.
Akebia announced it will submit a new NDA targeting CKD patients on dialysis, which will not involve additional trials.
Known as Relyvrio in the U.S., Amylyx’s AMX0035 may face a longer road to approval in Europe as the company reported that CHMP could reject its marketing authorization application.
The FDA approved Braeburn Pharmaceuticals’ new buprenorphine treatment option with extended-release medication that could pave the way for greater patient compliance.
While the exact settlement details are confidential, the deal will allow Amgen to launch its Stelara biosimilar no later than January 1, 2025.
Ex-FDA Neuroscience Director Billy Dunn was appointed to Prothena’s board of directors last week. Industry representatives and regulatory experts weigh in on the potential ethical implications.