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.
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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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The battle between bluebird bio and Errant Gene Therapeutics has escalated into a patent lawsuit. Errant alleges that bluebird’s gene therapies infringe on their patents for recombinant vectors.
If the panel votes in favor of the vaccine for children, it will move to the U.S. CDC. If both agencies support the data, children this age would be likely to receive their first shots in early November.
Sio Gene Therapies had a few big announcements last week, including a Fast Track Designation from the U.S. Food and Drug Administration and the reorganization of its R&D group.
The ongoing criminal trial of Holmes revealed Elizabeth Holmes and Theranos issued marketing materials to future partner Walgreens that included the use of Pfizer’s corporate logo.
The U.S. FDA has a busy period at the end of October heading into the first week of November.
Two months after being ousted by the Whitehead Institute over allegations of sexual harassment, prominent cell biology researcher David Sabatini has filed a counter lawsuit.
The FDA placed a clinical hold on Tryp Therapeutics’ Phase IIa trial for eating disorders, including binge eating disorder and hypothalamic obesity.
The designation is based on data from two Phase I trials, which showed the drug to be safe, demonstrating early efficacy.
The CDC supported the FDA’s approval of mixing and matching vaccines, where eligible populations can take a booster shot from another brand different from their initial series.
The upcoming changes will be less disruptive but will have far-reaching consequences throughout the pharmaceutical supply chain.