Policy
The administration’s direct-to-consumer pharmaceutical sales platform will offer products from Eli Lilly, Pfizer, Novo Nordisk, Amgen and more at a discount, though the impact of such pricing remains to be seen.
FEATURED STORIES
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.
An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
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THE LATEST
Shares of Massachusetts-based Minerva Neurosciences dropped Monday after the FDA issued a Refuse to File letter for the company’s schizophrenia drug, roluperidone.
Biogen announced the FDA has extended its review for ALS drug tofersen by three months. The regulator set a new PDUFA action date set of April 25, 2023.
The FDA has numerous activities and interactions with Phanes, Prestige Biopharma, Reata, Pfizer and more, providing clearance, approving clinical trials and other regulatory actions.
The FDA is likely to push back the Prescription Drug User Fee Act target action date for Travere Therapeutics’ sparsentan by three months..
Tiziana Life Sciences plans to submit an Investigational New Drug Application for a Phase I trial studying intranasal formulab, a breakthrough treatment option for Alzheimer’s Disease.
On Friday, the FDA approved Boostrix, a vaccine administered during the third trimester of pregnancy to prevent pertussis in infants under 2 months of age.
The FDA’s Center for Drug Evaluation and Research issued its briefing documents arguing for the market withdrawal of Covis Pharma’s Makena and will discuss the drug on Oct. 17-19.
The FDA had a fairly quiet week, approving drugs, providing clearance, greenlighting clinical trials, and other regulatory activities for Alnylam, Eli Lilly, Cytokinetics, and more.
Eli Lilly gained ground in the obesity market Thursday as the FDA granted Fast Track designation to Mounjaro (tirzepatide), an investigational drug for adults with obesity.
Provention Bio entered a co-promotion agreement with Sanofi ahead of the possible November approval of teplizumab. If approved, the drug would be the first approved to modify T1D.