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.
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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.
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The agency is requiring Sarepta to conduct a confirmatory trial, which Sarepta says will conclude by 2024.
SureClinical, a global provider of innovative cloud solutions for the health sciences market announced its new cloud-based regulatory document management solution for clinical investigator sites, SureISF.
MagForce successfully hosted the second session of its practice-oriented, unique, multifaceted application training for the use of the NanoTherm therapy system in treating brain tumors
The FDA advisory committee met and voted 11 to 2 against recommending approval of Brinavess, citing safety concerns. The FDA is not required to follow the recommendations of its adcoms, but typically does.
The U.S. Food and Drug Administration issued a warning letter to the company for misbranding its opioid addiction medication Vivitrol in promotional materials.
H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act (cited as the Lower Drug Costs Now Act of 2019), awaits a vote by the House in December.
Research shows modulation of the Hedgehog and androgen signaling pathways to discontinue the vicious circle leading to inflammation in the central nervous system and chronic demyelination
The company calls the system the first and only “ingestible event marker to transmit digital messages” from inside the body to a receiver without need for direct skin contact.
Shares of France-based Ipsen are down more than 2% on the Euronext Paris exchange after the U.S. Food and Drug Administration placed a partial clinical hold on its investigational treatment for fibrodysplasia ossificans progressiva (FOP) and multiple osteochondromas (MO).
Prescription drug prices dropped 1% last year, the first time such a drop has occurred in the United States in 45 years. The drop was driven primarily by a greater reliance on generic drugs and much slower increases in branded drugs, according to a government study.