Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aravive, Avexis, Fulcrum, Leading Biosciences, Milestone, Novartis, Novavax, Oncolytics, Oncopeptides, Oncoquest, Partner, Rafael, Seelos.
It took less than a week from the publication of Science 37’s whitepaper on March 12 encouraging virtual clinical trials to the FDA’s decision to endorse the idea, tailored to address the COVID-19 pandemic.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Behold.ai, Biome Analytics, COVID-19 Healthcare Coalition, Harvard Bioscience, Masimo, Medical Alley Association, Mitre, Nxgen MDx, Novocyt, Parallax Health Sciences, Senseonics, Smiths Group, Thornhill Medical, Xphyto Therapeutics.
The U.S. FDA has granted an emergency use authorization (EUA) to Cepheid Inc., of Sunnyvale, Calif., for a rapid molecular diagnostic to detect SARS-CoV-2, the virus that causes COVID-19. The Xpert Xpress SARS-CoV-2 test is designed for the qualitative detection of the novel coronavirus and runs on the company’s automated Genexpert systems, with a turnaround time of about 45 minutes.
Humanigen Inc., the Burlingame, Calif.-based developer of an anti-human-GM-CSF monoclonal antibody for preventing and treating cytokine storms, is urgently working to spin up a phase III trial of the candidate, lenzilumab, for COVID-19 patients whose immune systems have gone into overdrive.
Business as usual only three months ago has transformed into health care industry overdrive as biopharma and med-tech companies scramble to test and scale-up treatments, vaccines and diagnostics to address COVID-19.