Validating Fusion Pharmaceuticals Inc.’s radiopharmaceutical technology and manufacturing capabilities, Astrazeneca plc offered to buy the firm for $2 billion up front in cash, plus a contingent value right that could raise the total deal value by another $400 million. Read More
The U.S. FDA is holding a series of town halls on the use of sterilization methods as alternatives to ethylene oxide (EtO) in response to other federal agency rulemaking, and some of these changes in sterilization methods will not require a new regulatory filing. Read More
Affluent Medical SA said that its artificial sphincter, Artus, which treats stress urinary incontinence, was successfully implanted into the first patient. The company hopes that the device, which is the first artificial urinary sphincter that can be activated by the patient with a remote control, will be able to improve the quality of life of the millions of people suffering from urinary incontinence. Read More
Real life economics, not functionality, is the standard for determining a relevant antitrust market for distinct versions of a prescription drug, the U.S. Court of Appeals for the Second Circuit said as it schooled a lower court and handed Regeneron Pharmaceuticals Inc. a win in its ongoing litigation with Novartis AG and Vetter Pharma International GmbH over the prefilled syringe market for eye drugs Eylea (aflibercept) and Lucentis (ranibizumab). Read More
Asieris Pharmaceuticals Co. Ltd plans to submit a China NDA in the second quarter following positive phase III data for its cold light photodynamic drug-device combination product, Cevira, which is used as nonsurgical therapy for treating high-grade cervical dysplasia. Read More
Med-tech deal value in February jumped to $255.61 million, an increase of 137.23% from the $107.75 million in deals from January, yet below the 2023 monthly average of $886.13 million. On the M&A front, med-tech transactions hit their lowest point since May 2019, totaling only $16 million. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bionano, Cerus, Icecure, Mainstay, T2 Biosystems. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avail Medsystems, Caristo, Mendaera, Vicore Pharma. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Inheart, Peca Labs. Read More
