Pharus Diagnostics Inc. emerged from stealth mode to streamline precision medicine-based cancer screening with its new multi-cancer early detection liquid biopsy test. Spun out from Hsinchu, Taiwan-based Quark Biosciences Taiwan Inc. in July 2022, Pharus is developing solutions to detect cancer early via Oncosweep, its multi-cancer early detection (MCED) liquid biopsy test that evaluates microRNA (miRNA) within the body.
Jenscare Scientific Co. Ltd. has raised HK$225 million (US$29 million) in an initial public offering on the Stock Exchange of Hong Kong. Its shares opened at HK$28 per share, increased by over 9% in the middle of the day and closed at HK$28.25 on the first trading day of Oct. 10.
Australia’s TGA has opened a consultation on drug-device combination products to help sponsors understand the regulatory pathway through which their products will likely pass since these combination products may not fit within existing definitions for drugs, biologicals or medical devices.
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.
RSS
