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
In a subpoena filed Monday, the state of Texas asked Pfizer to turn over all communications with Meta regarding the tech company’s advertising practices.
The company teased data for efinopegdutide, a GLP-1/glucagon receptor co-agonist, in nonalcoholic steatohepatitis compared to Novo Nordisk’s semaglutide, which is not yet approved for NASH.
Following a May 2023 settlement with Amgen, J&J has also signed an agreement with Teva and Alvotech, allowing their Stelara biosimilar to enter the U.S. no later than February 21, 2025.
In its latest legal challenge to the Inflation Reduction Act, the U.S. Chamber of Commerce has appealed to a federal court to stop drug price negotiations until ongoing litigation plays out.
More than 3,000 state and local governments will receive nearly $19 billion in payments from drugmakers and pharmacy chains in the most recent round of opioid settlements.
Francis deSouza resigned from Illumina’s helm after strong campaigning from activist investor Carl Icahn and the ongoing regulatory roadblocks facing the company’s acquisition of GRAIL.
The Centers for Medicare & Medicaid Services announced Friday it will impose inflation penalties on 43 Medicare Part B drugs in the third quarter of 2023. The action follows fines on 27 drugs in March.
The FDA’s Antimicrobial Drugs Advisory Committee voted 21–0 that the companies’ respiratory syncytial virus antibody, nirsevimab, has a favorable benefit-risk profile in infants and young children.
The FDA has four target action dates this week for three supplemental approvals and one New Drug Approval.
A class-action lawsuit from thousands of third-party payers alleges that the companies broke racketeering laws to market their diabetes drug Actos, while not disclosing its bladder cancer risk.