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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The FDA has decided to extend the Prescription Drug User Fee Act (PDUFA) review date for TG Therapeutics’s ublituximab until December 2022.
On June 5, the FDA is expected to decide the fate of Acer Therapeutics’ experimental treatment for Urea Cycle Disorders (UCDs), ACER-001. CEO Chris Schelling spoke with BioSpace.
ZYESAMI, (aviptadil), being assessed by NRx Pharmaceuticals, failed a review conducted by the Data Safety and Monitoring Board (DSMB), with the board recommending that arm of the trial cease.
Shares of Enochian Biosciences plunged more than 36% after the Justice Department announced company cofounder Serhat Gumrukçu was arrested in a sordid 2018 murder-for-hire scheme.
Antios Therapeutics received a clinical hold on its Hepatitis B virus (HBV) combinatorial therapy from the U.S. Food and Drug Administration on Wednesday.
Johnson & Johnson and Momenta Pharmaceuticals have filed a patent infringement lawsuit over a generic multiple sclerosis drug developed by India-based Natco, Gland Pharma and Mylan.
Concerns are mounting for people that have been given Pfizer’s Paxlovid treatment regimen after contracting COVID-19, only to become positive for the infection once again.
Monday, Moderna told a Delaware federal court that it was immune from patent-infringement charges over the COVID-19 vaccine because it supplied the vaccine for a U.S. government effort.
Vanda has again taken legal action against the FDA over its supposed failure to grant tradipant Fast Track designation. In its complaint, Vanda is challenging the FDA’s decision to deny the designation.
If approved, etranacogene dezaparvovec would be the first gene therapy treatment for hemophilia B.