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Regulatory
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Hand dividing blocks spelling DEAL

UK’s antitrust agency takes exception to Cochlear-Oticon merger

June 30, 2023
By Mark McCarty
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.
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Regulatory actions for June 30, 2023

June 30, 2023
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.
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Roctavian approved in US as first gene therapy for hemophilia A

June 29, 2023
By Karen Carey and Amanda Lanier
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.
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Celltrans’ type 1 diabetes treatment receives FDA approval

June 29, 2023
By Lee Landenberger
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.
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Elderly hands holding broken brain structure

Bioxcel shares plunge on FDA warning letter despite promising data for Alzheimer’s acute agitation candidate

June 29, 2023
By Marian (YoonJee) Chu and Karen Carey
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.
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Alvotech’s Humira biosimilar not at US starting gate

June 29, 2023
By Mari Serebrov
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).
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Regulatory actions for June 29, 2023

June 29, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Candela, Cresilon, Zap Surgical.
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Maker of orthodontic planning software snares FDA warning for software validation lapse

June 28, 2023
By Mark McCarty
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.
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Driven by need, adcom gives thumbs up to FOP drug

June 28, 2023
By Mari Serebrov
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).
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JW Pharma refiles Taiwan IND for URC-102 phase III in heated search for novel gout drug in Asia

June 28, 2023
By Marian (YoonJee) Chu
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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