The U.K. Competition and Markets Authority (CMA) has declared its opposition to a proposed merger between Cochlear Ltd. And Oticon Medical A/S, two of the prime movers in the bone conduction implant space.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ausper, Bristol Myers Squibb, Can-Fite, Celltrans, Endo, Genenta, Geron, Harbour Biomed, Ipsen, Italfarmaco, Paladin Labs, Recce.
Becoming the first gene therapy approved for hemophilia A, Roctavian (valoctocogene roxaparvovec) finally received the U.S. FDA’s blessing on June 29, after developer Biomarin Pharmaceutical Inc. spent nearly three years working to address issues raised in a 2020 complete response letter. The approval came a day prior to the June 30 PDUFA date.
Two years after a U.S. FDA advisory committee agreed that Celltrans Inc.’s pancreatic islet cellular therapy had a favorable risk-benefit profile, the agency has finally approved Lantidra (donislecel) for treating adults with type 1 diabetes.
Although the highest dose of Bioxcel Therapeutics Inc.’s BXCL-501 hit the primary endpoint in the phase III Tranquility II trial for acute agitation in Alzheimer’s disease patients, shares fell dramatically on June 29 by 64% when investors learned the company received an FDA warning letter over infractions at a trial site.
One of the companies wanting to be part of the upcoming U.S. launch of Humira biosimilars is instead exploring options to raise additional capital so it can continue advancing its biosimilar pipeline in the near term. Alvotech Holdings SA, a pure-play biosimilars company based in Iceland, initially had hoped for FDA approval June 28 for AVT-02, developed as both an interchangeable and biosimilar to the high-concentration formulation (HCF) of Abbvie Inc.’s blockbuster autoimmune drug, Humira (adalimumab).
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Candela, Cresilon, Zap Surgical.
Makers of dental equipment don’t typically show up on the U.S. FDA enforcement radar screen, but the introduction of biologics and software into routine dental practice has upped the regulatory stakes. This can be seen in the June 20, 2023, warning to Vitang Technology LLC, of Tustin, Calif., which cited the company for failure to validate a change of software used in orthodontic treatment planning systems, but the FDA reinforced the notion that claiming that the agency approved or cleared the device is also a violation of the Code of Federal Regulations.
Despite imperfect data and the use of post hoc analyses to overcome a failed endpoint, the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 10-4 June 28 that Ipsen SA’s ultra-rare bone disease drug, palovarotene, demonstrated efficacy in treating patients with fibrodysplasia ossificans progressiva (FOP).
South Korea’s JW Pharmaceutical Corp. announced a redo of its IND application to the Taiwan FDA on June 27 for its phase III trial on gout treatment URC-102 (epaminurad). The second filing comes in response to a regulatory rejection in March citing a problem with the proposed reference drug.
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