FDA investigators observed many weaknesses in current good manufacturing practice (cGMP) procedures, among other quality lapses, during an inspection of Janssen’s drug manufacturing facility in Gurabo, Puerto Rico. Source: Drug…
Novartis has agreed to manufacture Carisma Therapeutics’ new line of bioengineered macrophages which, like CAR-T cells, can be reprogrammed to attack patient-specific tumors. Source: Drug Industry Daily
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In a revised draft guidance released yesterday, the FDA outlined its latest thinking on prescription drug supply-chain verification systems that companies will need to implement to comply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…
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