Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arch, Boehringer Ingelheim, Eli Lilly, Genflow, Ligand, Mabwell, Micurx, Puma, Via Nova.
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.
The U.S. FDA’s Sept. 6 hearing of the Patient Engagement Advisory Committee (PEAC) tackled the question of health equity, a discussion that touched on several issues such as accessibility. One of the committee’s recommendations was that the FDA assist the Centers for Medicare & Medicaid Services (CMS) with the latter’s task of developing codes for payment, not the kind of task to which the FDA is typically assigned.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Exactech, Tyber Medical.
Krystal Biotech Inc. has received IND clearance from the FDA for KB-408 for the treatment of α1-antitrypsin deficiency (AATD). KB-408 is a modified, replication-defective, nonintegrating HSV-1-derived vector carrying two full-length copies of the serpin family A member 1 gene (SERPINA1) to enable expression of α1-antitrypsin (AAT).
Via Nova Therapeutics Inc. has received clearance of its IND application from the FDA for its influenza A nucleoprotein inhibitor, VNT-101. The novel investigational small molecule is directed against a novel target, the influenza A nucleoprotein, and is being developed for treatment of seasonal influenza A infection.
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 submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic, Microvention.
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