Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbott, Biocardia, Boston Scientific, Jenavalve, Medtronic, Sensydia.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Electrocore, Embolx, Endra Life Sciences, GE Healthcare, Healwell, Nihon Medi-Physics, Siemens Healthineers, Varian Medical, Well Health.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Epitel, Novartis, Visby Medical.
Sanofi SA gained U.S. FDA approval for fitusiran as a first-in-class siRNA therapy for hemophilia. Branded Qfitlia, the antithrombin-lowering therapy is indicated for use as a prophylactic treatment to prevent or reduce bleeding episodes in people with hemophilia A or B, with or without inhibitors.
Peter Marks’ March 28 letter giving one week’s notice of his resignation as director of the U.S. FDA’s Center for Biologics Evaluation and Research (CBER) is sending more ripples of uncertainty throughout the industry. Marks, who has helmed CBER for nearly a decade, blamed his departure on recently confirmed Health and Human Services (HHS) Secretary Robert Kennedy, who has made a career out of his anti-vaccine stance.
Transplanting an animal organ into a human is now a closer reality following the successful xenotransplantation of a genetically modified pig liver into a patient diagnosed with brain death in China. The operation was intended to evaluate organ function over a 10-day period. This is a complex experimental trial that did not involve removing the patient's liver and still requires further study. However, the positive preclinical results suggest this strategy could save the lives of those waiting for a human organ, at least in certain cases.
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