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Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akston, Biolexis, Calithera, GSK, Intellia, Regeneron, Sanofi.
Sanofi SA and GSK plc said new phase III data show their adjuvanted bivalent D614 and beta (B.1.351) COVID-19 vaccine candidate responded well against omicron despite it being designed to fight the original SARS-CoV-2 virus and the beta variant.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Alterity, Amryt, Astrazeneca, Biontech, CNS, Fusion, Menarini, Merck & Co., Novartis, Novavax, Radius, Realta, Rockwell, Valneva.
Pfizer Australia Holdings Pty Ltd. has revised its offer to acquire digital health company Resapp Health Ltd. after results from an independent data confirmation study of its COVID-19 algorithm failed to meet Pfizer’s required sensitivity and specificity results.
While the biopharma industry was widely praised for its fast response to the COVID-19 pandemic, moves are afoot to ensure that the world is better prepared in case another pandemic hits. Moderna Inc. was one of the companies that blazed a trail in the early stages of the pandemic with its revolutionary mRNA vaccine. Now the firm is investing in manufacturing and R&D in the U.K. to make good on a pledge to respond to the next global disease threat within 100 days of its detection.