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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chipscreen, Gilead, Inmed, Prevail, Samsung Bioepis.
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.
Hoth Therapeutics Inc., of New York, and Voltron Therapeutics Inc. have formed a joint venture, Halovax, to develop a vaccine for COVID-19 that can be advanced to clinical testing.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alivecor, Arch Therapeutics, Canon Medical.
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.
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