Lawmakers voted last night to fund the federal government with a $1.5 trillion, 2,700-page omnibus package that includes emergency aid for Ukraine and funds the government for the rest of…
Lawmakers were poised late yesterday to again vote on extending the continuing resolution (CR) to temporarily fund the U.S. government at fiscal year (FY) 2021 levels while continuing to squabble…
In a revised draft guidance released yesterday, the FDA outlined its latest thinking on prescription drug supply-chain verification systems that companies will need to implement to comply with the Drug…
Drugmaker Catalent Massachusetts drew a Form 483 with four observations following an FDA inspection of its Chelsea, Mass., drug manufacturing facility. Source: Drug Industry Daily
Efanesoctocog alfa, a bioengineered clotting factor being co-developed by Sanofi and Sobi, practically eliminated bleeding episodes in patients with hemophilia A who took it as a prophylactic weekly injection. Source:…
Despite pushing for greater clinical trial participation of minority patients via a five-year action plan, the FDA’s efforts appear to have made little difference for Black patients, the latest analysis…
Teva Pharmaceuticals and Natco Pharma have announced the launch of the first generic versions of Revlimid (lenalidomide) in the U.S., a move that will take a bite out of Bristol…
Novartis and Voyager Therapeutics have joined forces to develop adenovirus viral vectors (AAV) that could cross the blood-brain barrier, potentially delivering gene therapy deep into the brain. Source: Drug Industry…
The International Coalition of Medicines Regulatory Authorities (ICMRA) is about to start two pilot projects on drug manufacturing inspections, a senior industry official said. Source: Drug Industry Daily
A newly proposed bill would make it easier for the FDA to expeditiously remove drugs marketed on accelerated approvals if they don’t live up to their clinical promise. Source: Drug…