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.
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After shoring up quality control at its Reykjavik manufacturing facility, the biotech has resubmitted a BLA to the FDA seeking an interchangeability designation for its Humira biosimilar.
The settlement, announced Wednesday, ends a three-year legal battle allowing Teva Pharmaceuticals to make a generic version of Alkermes’ alcohol and opioid dependence drug Vivitrol.
In this special report, BioSpace examines how the biopharma industry is grappling with impending consequences of the Inflation Reduction Act.
However, a lack of regulatory harmonization risks undermining the effective implementation of these technology-driven approaches.
Citing lack of evidence and manufacturing issues, the regulator has rejected Outlook Therapeutics’ bid to have its bevacizumab formulation approved for wet age-related macular degeneration.
In the latest salvo, Pfizer and BioNTech fired back at Moderna and asked the U.S. Patent and Trademark Office to invalidate patent claims over the COVID-19 vaccines they say are overly broad.
The Biden administration on Tuesday released a much-anticipated list of the first 10 medicines included in Medicare’s Drug Price Negotiation Program under the Inflation Reduction Act.
The British drugmaker filed a lawsuit on Friday in the U.S. District Court for the District of Delaware claiming the Inflation Reduction Act conflicts with the goals of the Orphan Drug Act.
Following a countersuit by Amgen and Horizon Therapeutics, the Federal Trade Commission has temporarily suspended its challenge to the multi-billion dollar merger between the two companies.
A second trial shows Novo Nordisk’s Wegovy improves heart health. Meanwhile, many other drugs are beginning to face generic competition, including from newly approved biosimilars.