Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Germitec, Youda.
Distinguishing between contract law and patent law, the U.S. Court of Appeals for the Third Circuit ruled against a Merck KGaA subsidiary, saying Ares Trading SA is still on the hook for paying royalties to a research partner through 2027 on sales of its cancer drug Bavencio (avelumab), a PD-L1 inhibitor granted accelerated approval in 2017 as a treatment for metastatic Merkel cell carcinoma.
Hope for definitive resolution of the controversy about the superiority of transcatheter edge-to-edge repair of mitral valves over medical therapy in individuals with symptomatic heart failure and functional mitral regurgitation were dashed at the European Society of Cardiology meeting this weekend.
Litigation between companies in the med-tech space often revolves around patents, but the ongoing series of lawsuits between Philips Respironics Inc. and Soclean Inc. are directed toward the interaction between CPAP machines and CPAP cleaning systems.
The U.S. FDA is accused of dragging its feet on making public the devices for which it granted market access under the de novo program, and the agency recently been scrambling to bring these decision summaries to light.
New hires and promotions in the med-tech industry, including: Accuray, Biofidelity, Insightec, Istar Medical, Oxford Biomedica, Polaroid Therapeutics, Samsara Vision.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott Laboratories, Access Vascular, Aditxt, BD, Charles River, Edwards Lifesciences, Insightec, Kymanox, Lungpacer Medical, Onward Medical, Pearsanta, Samsung Medison, Scibase, SHL, Sonio.
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