The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA lists entities recognized under ASCA program.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apyx Medical, Braid Health, Cardiawave, Cepheid, Fluidigm, Neuronetics, Zymo Research.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aspen Surgical, Baxter, Babybe, Blue Earth Diagnostics, Bodycad, Canon Medical Systems, Cloudbreak, Cohealo, Curtis Mathes, DarwinAI, Emphysys, Exactech, Flirtey, Fluidx, Glassbeam, Gigcapital2, Harpak-Ulma, Insightec, Ixlayer, Lockheed Martin, Median Technologies, Natus Medical, Nucleis Radiopharmaceuticals, Pack Health, Paramit, Premier, Protek Medical Products, Storm ID, Todos Medical, Uphealth, Vault Health, Zebra Medical Vision.
More than a third of the money raised through biopharma financings in 2020 was raised by companies developing either a therapeutic or a vaccine for COVID-19, yet completely wiping away those totals still leaves the year with $76.8 billion, a full 12% more than the next highest year.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Appili, BMS, F-star, Mustang, Obseva, Polypid, Viatris.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Apnimed, Bausch, Capricor, Celularity, City of Hope, GSK, Kubota, Oramed, Principia, RDIF, Reithera, Strongbridge, Targovax, Tolmar.
An antibody cocktail developed by Regeneron Pharmaceuticals Inc. has received emergency use authorization (EUA) from the FDA for the treatment of mild to moderate COVID-19. Monoclonal antibodies (Mabs) such as Regeneron's, called casirivimab and imdevimab, "have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load," the company said.
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