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 lawsuit was filed by Public Health and Medical Professionals for Transparency, a nonprofit organization recently formed with a mission to obtain the data for the COVID-19 vaccines.
The best way to battle the dominant Delta strain is booster vaccines. So far, initial data suggests boosters are likely to help battle Omicron as well. For that and more COVID-19 news, read on.
A U.S. Congress subcommittee unanimously approved the ACT for ALS bill in a decision that could soon pour massive funding into the search for treatment for this debilitating and deadly disease.
Throughout her defense, she cast blame for Theranos’ troubles on her former partner and lover, Ramesh “Sunny” Balwani, as well as subordinates who she claimed misled her.
Reuters alleges Johnson & Johnson knew of the ketoacidosis risk of its diabetes drug Invokana but covered it up.
Shares of Reata Pharmaceuticals have plunged nearly 40% in premarket trading after an FDA advisory panel recommended against the approval of its Alport syndrome disease treatment, bardoxolone.
The counterclaim by an alleged victim of MIT professor David Sabatini said she was coerced into sex and that Sabatini’s laboratory had a “toxic and sexually charged” environment.
Vyera Pharmaceuticals agreed to pay $40 million to settle federal allegations to radically increase the price of toxoplasmosis drug Daraprim and prevent generic competition.
The WHO’s latest decision is based on advice from an independent panel of experts who evaluated data from 16 randomized controlled studies.
In the staff documents, the FDA scientists expressed concerns over the Reata clinical data that was submitted.