Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
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.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
Shares of specialty pharmacy company Aquestive Therapeutics are up more than 18% in premarket trading following a late Friday afternoon approval from the U.S. FDA for Exservan, a treatment for amyotrophic lateral sclerosis.
Patent covers use of MANF in Glaucoma, Wolfram Syndrome and Retinitis Pigmentosa
The latest approval for Calquence, a Bruton tyrosine kinase inhibitor, was granted under the FDA’s Real-Time Oncology Review and newly established Project Orbis programs.
The analysis said that if the Pelosi plan were to become the law of the land, it would cut revenues by more than half for companies with affected medicines and would also lead to a “nearly 90% reduction in new medicines” developed by those smaller U.S.-based companies.
The approval marks the first time a Korean company independently brought a drug from discovery to FDA approval.
The AP report shows that in China, Mundipharma representatives are informing doctors that OxyContin is less addictive than other painkillers, which is a similar tactic the company used in the 1990s in the United States.
The U.S. Food and Drug Administration approved Alnylam Pharmaceuticals’ Givlaari (givosiran) for acute hepatic porphyria.
Heidelberg Pharma contributing Antibody Targeted Amanitin Conjugate technology for Emergence Therapeutics antibody target
Mitchell Hamline School of Law is pleased to announce the first annual Roy Snell Health Care Regulatory & Compliance Writing Competition.
Synergistic Therapeutics LLC has recently announced the issuance of a U.S. Patent for a Topical Analgesic Lotion that relieves pain.