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.
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.
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.
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.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4Web Medical, Siemens Medical Solutions, Sun Nuclear.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acculine, Clearnote, Grail, Percassist, Regeltec, Spectral AI, Spectral MD.