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
The U.S. FDA issued a Complete Response Letter (CRL) over Acadia Pharmaceuticals’ supplemental New Drug Application (sNDA) for Nuplazid for hallucinations and delusions associated with dementia-related psychosis.
If you’re one of the 17% of Americans that have been fully vaccinated against SARS-CoV-2, you are probably feeling some level of relief. But the CDC warns not to throw your mask away just yet.
Sepsis is among the best-known and least effectively treated conditions in the modern world. The standard of care has failed for these infections, leaving the U.S. healthcare system with $62 billion and 270,000 deaths annually. Globally, 11 million die from sepsis each year. Effective drugs and diagnostics are available. They’re just not used.
In a statement, the company said, “Bristol Myers Squibb is in compliance with all applicable tax rules and regulations. We work with leading experts in this area and will continue to work cooperatively with the IRS to resolve this matter. Beyond that, we don’t comment on ongoing regulatory matters.”
Three members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee published their objections to the drug in a JAMA article.
The U.S. Food and Drug Administration approved two new treatments for multiple myeloma and pulmonary hypertension.
Citing Russia’s agricultural regulatory agency, Reuters reported the new vaccine called Carnivac-Cov will be used against the virus in dogs, cats, foxes and mink.
Illumina plans to continue to pursue its acquisition of Grail Inc. despite the objection of the U.S. Federal Trade Commission.
AbbVie won the NDA on the strength of definitive results in a Phase III ADVANCE trial, where atogepant met all six secondary endpoints at the 30-60 mg dose range, proving statistically significant in heading off migraines in nearly 2500 adult participants who experience them between 4-14 days per month.
Merck is having a very busy week. Here’s today’s news.