In a positive sign for its future success, Harbinger Health Inc. closed a $140 million series B fundraising round, bringing total funds raised since its founding in 2020 to $190 million. The new funds will be used to support completion of the company’s CORE-HH 10,000 participant study of its blood-based multicancer early detection (MCED) test. The company expects to complete enrollment in CORE-HH, a three-part case control, adaptive study with development, validation and longitudinal cohorts in 2024. Read More
The U.S. FDA may be the most prominent agency in the federal government when it comes to the use of real-world data (RWD), but the National Institutes of Health is keen to immerse itself in this trove of information. The agency has made a request for public comment on how NIH centers can best leverage RWD for biomedical and behavioral research, although some ethical and practical considerations may have to be overcome. Read More
Inventors from the International School of Advanced Studies (SISSA) in Trieste, Italy reported filing a patent for a graphene-based device for the targeted mucosal and transmucosal delivery and/or controlled release of active pharmaceutical ingredients (APIs) for various therapeutic applications when on-demand drug administration is needed. Read More
The fungus Candida auris has become an urgent clinical problem at a shocking speed. It was not even mentioned in the U.S. CDC’s 2013 reports on antimicrobial threats, but was one of five pathogens on the agency’s 2019 top-tier Urgent Threat List. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Benchmark Medical, Better Therapeutics, Biostem, Biovica, Gedi Cube, Lazurite, Medaustron, Nyxoah, Raysearch, Renovaro Biosciences, Resmed. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Seastar Medical. Read More
