A new analysis of Actinogen Medical Ltd.’s phase II Xanadu trial showed that in biomarker-positive patients with mild Alzheimer’s disease there was a clear clinical effect with lead compound Xanamem not seen in the earlier trial.
CSPC NBP Pharmaceuticals Co. Ltd. entered an agreement that will grant it exclusive rights to Harbour Biomed Co. Ltd.’s anti-FcRn antibody, batoclimab (HBM-9161), in greater China, including Hong Kong, Macau and Taiwan.
Guangdong Pulse Medical Technology Co. Ltd. received marketing approval from China’s NMPA for its left atrial appendage (LAA) closure product called the Leftear occluder system.
Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Pty. Ltd. has had its hopes of entering the U.S. market dashed yet again following a second decision from the FDA that Febridx has not demonstrated substantial equivalence to the predicate device identified in its 510(k) application.
Japan’s Ministry of Health, Labour and Welfare (MHLW) has given Intuitive Surgical Inc. the green light for its Da Vinci SP surgical system. The surgical system has been cleared for use in general surgeries, thoracic surgeries (excluding cardiac procedures and intercostal approaches), urologic surgeries, gynecological surgeries, and trans-oral head and neck surgeries.
Cerecin Inc. has successfully closed the first tranche of a series IIB financing with investors from South Korea, with SK Securities Co. Ltd. and KNT Investment LLC leading the round.
Cerecin Inc. has successfully closed the first tranche of a series IIB financing with investors from South Korea, with SK Securities Co. Ltd. and KNT Investment LLC leading the round. Proceeds from the financing, of undisclosed value, will help the company advance clinical studies of its CER-0001 (tricaprilin) in migraine and infantile spasm.
Novo Nordisk A/S received marketing approval from China’s NMPA for its smart insulin pen Novopen Six that automatically collects and stores the date and time of injections and the number of units of insulin that users take.
Koutech Medical Robotics (Shanghai) Co. Ltd. reported it has raised “hundreds of millions of yuan” in a series A round to support the development of its surgical robot. The round is led by Qiming Venture Partners.
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