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
Acquires Orphan Drug Designation for betahistine for the treatment of obesity associated with Prader-Willi syndrome (PWS)
Positive interim analysis demonstrated proof-of-biology and proof-of-concept for BIIB067
Meeting with FDA confirmed that studies previously conducted using first generation ProSavin® may be considered part of a single development program with AXO-Lenti-PD
Medtronic is notifying customers worldwide of a voluntary field corrective action for its Puritan Bennett(TM) 980 (PB980) ventilator series. Medtronic initiated this field action on September 19, 2018.
Ingenza is pleased to announce that Syngenta is exercising its commercial licensing option for a technology that enables the development of innovative crop protection products.
he Ministry of Health and Prevention recently met with a Chinese delegation to discuss mutually beneficial cooperation in the use of technological innovations such as artificial intelligence (AI) in the health care sector.
Noted biotech investor G. Steven Burrill will only spend 30 months in jail for his involvement in wire fraud and tax evasion. Burrill pleaded guilty to the charges last year and, at the time, faced up to 30 years in prison. Now, he will serve less than one-tenth of that amount.
Researchers who focus on HIV vaccines are caught in the middle of a political battle over funding of fetal stem cell research.
The FDA is often publishing draft guidelines and asking for expert feedback on that guidance. It’s been a busy week in this regard, with several areas of healthcare and drug development and manufacturing being covered by the agency. Here’s a look.
Prior to being acquired by Medtronic, the two companies were involved in what the DOJ called kickback schemes to encourage unauthorized use of a medical device.