Approvals from the U.S. FDA are up more than 16% from last year, with 113 drugs approved in the first eight months of 2023. New approvals include two different treatments for relapsed or refractory multiple myeloma, two treatments for ultra-rare diseases and a biosimilar to Biogen Inc.’s Tysabri. In August the FDA greenlighted 13 drugs, approving three NDAs, six BLAs, two supplemental NDAs and two supplemental BLAs.
The U.K.’s Competition Appeal Tribunal has rejected appeals by drugmakers, including Actavis plc and Allergan Inc., against a ruling by regulators that they hiked the price of a life-saving adrenal insufficiency drug excessively for almost a decade, saddling the companies with fines amounting to nearly £130 million (US$159 million).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 89bio, Aligos, Disc Medicine, Dizal, Genprex, Immix, Krystal, Leucid, Mesoblast, Taysha Gene.
Safety concerns overrode benefit when the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted unanimously, 19-0, Sept. 21 that the potential risks of Intarcia Therapeutics’ ITCA-650 outweighed the compliance and A1C-lowering benefits the twice-yearly implantable exenatide-device combination product could provide for adults with type 2 diabetes.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ARS, Atara, Everest, Genflow, Hepagene, Menarini, Merck, Spybiotech, Stemline, Takeda.
The U.S. FDA is going straight to final guidance with its “Considerations for the conduct of clinical trials of medical products during major disruptions due to disasters and public health emergencies [PHEs].”
Shares of ARS Pharmaceuticals Inc. (NASDAQ:SPRY) plummeted 55.8% Sept. 20 on word that the U.S. FDA issued a complete response letter (CRL) for Neffy, despite receiving a recommendation for approval in May from the agency’s advisory committee (adcom) and following a three-month delay in action.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 60 Degrees, AB Science, Astex, Atamyo, Beigene, Biophytis, Gilead, GSK, Intelgenx, Merck & Co., Otsuka, Pfizer, Rhythm, Viiv.
A Sept. 21 U.S. FDA advisory committee meeting will either be a “Hail Mary” or a last gasp of life for ITCA-650, a twice-yearly implantable exenatide-device combination product intended to improve glycemic control in adults with type 2 diabetes.
RSS
