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
U.S. Food and Drug Administration(FDA) has granted Orphan Drug designations to Editas Medicine and Neurocrine Biosciences.
On Thursday at the White House, President Biden paid tribute to the 1 million American lives lost due to COVID-19.
AbbVie and Teva are reportedly ready to pay over $5 billion to quiet the over 3,500 opioid liability lawsuits filed against them over their painkillers.
Police documents reveal a May 2 dated TRO against Siegall concerning a fourth degree domestic violence gross misdemeanor charge.
With regulatory approvals beginning to break through, attendees at ISCT’s annual meeting set out along the translational pathway. Organizers shared their findings with BioSpace.
Usama Malik, the former chief financial officer of Immunomedics, has been indicted for insider trading, five months after the U.S. Securities and Exchange Commission leveled charges.
Less than one month after he was appointed as chief financial officer of Moderna, Jorge Gomez abruptly departed the company due to an ongoing investigation at his former company.
An investigation conducted by the U.S. House of Representatives shows Emergent was forced to destroy nearly 400 million doses of the vaccine. The company disputes the report’s claim.
The revised PDUFA action date for miglustat is August 29, 2022, while the new date for cipaglucosidase alfa is October 29, 2022. Amicus expects the agency to approve the applications together.
Could big pharma buy out much of the biotech industry? Yes, according to analysts. But that’s not likely to happen anytime soon.