LONDON – The U.K. Medicines and Healthcare products Agency (MHRA) has given approval for the first-in-human study of Codagenix Inc.’s COVI-VAC, a live, attenuated whole virus COVID-19 vaccine, which is engineered to be structurally identical to wild-type SARS-CoV-2, but is much slower to replicate.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: USTR seeking input on nations with poor IP protections; NICE sticks with ABI to evaluate PAD; Health Canada to extend COVID-19 flexibilities.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Activepure Technologies, Aditx Therapeutics, American Bio Medica, Ashvattha Therapeutics, Babylon Health, Builtspace, Diabeloop, Efemoral Medical, Eurofins Technologies, GE Healthcare, Hummingbird Bioscience, Insightec, Lifescan, Luminultra, Mymedbot, Novacyt, Novocure, Oncimmune, Pacific Biosciences, Roche, SonALAsense, Tempus Labs, Todos Medical, Variscite, Welldoc.
The latest global regulatory news, changes and updates affecting biopharma, including: Health Canada to extend COVID-19 flexibilities; USTR seeking input on nations with poor IP protections.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Acceleron, Amag, Ascletis, Antengene, Astrazeneca, Avelas, Biontech, Codagenix, Daiichi Sankyo, EMD, Gamida, Gannex, Graphite, Legend, Merck KGaA, Mindmed, Open Orphan, Pfizer, Sobi.
TORONTO – Waterloo, Ontario-based DarwinAI Corp. and Raleigh, N.C.-based Red Hat Inc.are developing a suite of deep neural networks for COVID-19 detection and risk stratification via chest radiography in cooperation with Boston Children’s Hospital. DarwinAI designed COVID-Net as “explainable” artificial intelligence (AI) that illuminates the inner workings of AI-driven medical technologies and promptly offered it on an open-source platform for the broader hospital community.
Michael Mina, assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health, again criticized the U.S. FDA for taking a conventional regulatory approach to rapid antigen tests for the pandemic. However, not everyone at the FDA’s parent department deserves brickbats. Mina said Assistant Secretary for Health Brett Giroir deserves a lot of credit for assisting in the effort to stand up pilot studies for rapid antigen tests that could be used to restore the U.S. economy even in the absence of a fully rolled-out vaccination campaign.
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