Policy
The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
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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Louisiana Attorney General Jeff Garland sued UnitedHealth Group over Medicaid fraud. In a lawsuit filed earlier this week, Garland alleged the insurance company overinflated drug charges.
Biogen has withdrawn its Marketing Authorization Application (MAA) for European approval of Aduhelm after regulators hinted data was not strong enough to support potential approval.
As Omicron dominates the COVID-19 landscape, scientists are urging the FDA to reconsider how the agency defines immune responses.
The WHO has indicated support for Pfizer’s Paxlovid and reversing a previous decision on using antiviral remdesivir, now recommending it in cases of mild to moderate COVID-19.
Toxicities and concerning patient survival data sparked a U.S. Food and Drug Administration advisory committee to recommend shutting the door on single-arm clinical studies of PI3K inhibitors.
The COVID-19 pandemic will end one day and, when it does, some biopharma companies will need to revert to a more normal way of working with others.
Servier is poised to go to market soon after the Phase III trial of its proposed drug for leukemia closed with positive results.
British employees of pharma giant GlaxoSmithKline (GSK) have voted to strike against the company’s recent pay raise. The employees are backed by British labor union Unite.
The U.S. FDA’s Oncologic Drugs Advisory Committee is holding a meeting on April 21, 2022, to discuss safety findings across the entire class of PI3K inhibitors for hematological cancers.
Arcturus Therapeutics announced positive Phase III trial results for its mRNA vaccine candidate, ARCT-154, intended to prevent COVID-19 caused by the SARS-CoV-2 virus.