Though the PDUFA date for its BLA wasn’t until March 30, 2024, Vertex Pharmaceuticals Inc. celebrated the U.S. FDA approval Jan. 16 for Casgevy (exagamglogene autotemcel), expanding use the CRISPR/Cas9 gene-edited cell therapy in patients, 12 and older, with transfusion-dependent beta-thalassemia.
The U.S. FDA has announced a class I recall of Iveninx large-volume infusion pumps made by Fresenius Kabi USA of Lake Zurich, Ill., due to a mechanical issue with fluid valve pins that could cause the pumps to shut down. Fresenius is rolling out a remediation plan for more than 900 pumps affected by the recall, which to date has been associated with no reports of injury or death.
CSPC Pharmaceutical Group Ltd. has announced FDA approval of an IND application for JMT-106, a bispecific fusion protein drug, for glypican-3 (GPC3)-positive solid tumors.
The ongoing controversy over the use of ethylene oxide (EtO) as a medical device sterilant has yielded a certification by the U.S. FDA for hydrogen peroxide as an alternative category A sterilant. The news is a welcome bit of relief for industry and for patients as the Environmental Protection Agency still seems bent on imposing what some in industry see as draconian controls on EtO, which is still employed to sterilize half of all medical devices used in the U.S. each year.
Medtronic plc received the greenlight from the U.S. FDA for its latest deep brain stimulation system, the Percept RC. The rechargeable neurostimulator includes the company’s sensing technology which captures data from brain signals and allows for more personalized therapy.
The U.S. FDA is promising to make 2024 a “breakout” 12 months for gene therapies, with a number of initiatives to promote clinical development, approvals and uptake. “This is a great year to focus on gene therapy,” said Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA. “I just want to focus on moving ahead gene therapy,” he told attendees of the J. P. Morgan Healthcare Conference on Jan. 8.
The U.S. FDA’s latest draft guidance on discussions of off-label uses with doctors revisits a controversial subject that has previously migrated into the courts, and by some accounts, may do so yet again. In comments to the docket, the Washington Legal Foundation (WLF) argued that this latest attempt to regulate commercial speech is another example of the agency’s “flagrant disregard for drug and device manufacturers’ free speech rights,” which WLF seemed to suggest is an actionable violation of the First Amendment.
Corbus Pharmaceuticals Holdings Inc. has obtained FDA clearance of its IND application for CRB-601, a TGF-β-blocking monoclonal antibody targeting the integrin αvβ8. Enrollment in a first-in-human phase I study will open in the first half of this year.
The U.S. FDA issued Astellas Pharma Inc. a complete response letter for its BLA for zolbetuximab, citing unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for claudin 18.2-targeting drug, which was recently listed in the 2024 edition of Clarivate’s Drugs to Watch.
RSS
