The emergence of the Omicron variant of the SARS-CoV-2 virus has sparked a vigorous reaction around the globe, which in the U.S. includes steps taken by the Biden administration to ensure that the roughly 100 million people who have received an initial vaccination regime will receive a booster if eligible. The administration also reported Dec. 2 that it will take steps to ensure that home testing will be covered by private payers, all of which amounts to a massive boost in business for manufacturers of vaccines and tests despite concerns about how the Omicron variant might affect vaccine and test performance.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Active Life Scientific, Amra Medical, Qiagen.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aditxt Technologies, Aipharma Global Holdings, Becton, Dickinson and Co., Eurofins Scientific, Janssen Research & Development, Nurx, One Mind Psyberguide, Ovia Health, Syndi, Tempus, Venclose.
While discussing positive data on its lead candidate lenzilumab for treating hospitalized COVID-19 patients, Humanigen Inc.’s CEO sparred a bit with the FDA and its refusal to grant the treatment emergency use authorization. The monoclonal antibody, Cameron Durrant told investors on a Dec. 2 call, could possibly have saved 60,000 to 70,000 patients while the company waits for another meeting with the FDA.
The U.S. Court of Appeals for the Federal Circuit struck a blow Nov. 30 to Biogen Inc.’s blockbuster multiple sclerosis (MS) drug, Tecfidera, affirming a lower court’s determination that a patent claiming a method of treating MS was invalid for lack of written description. In two other precedential cases the next day, the appellate court opened the door for Arbutus Biopharma Corp. to seek royalties on Moderna Inc.’s COVID-19 vaccine.
The U.K. is stepping up its response to the Omicron COVID-19 variant after the country’s regulatory agency approved Xevudy (sotrovimab), the antibody therapy from Glaxosmithkline plc and Vir Biotechnology Inc. At the same time the country placed orders for 114 million more doses of COVID-19 vaccines from Pfizer Inc. and Moderna Inc., for use in 2022 and 2023.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cocrystal, Codiak, Entos, EOM, Fusion, Glaxosmithkline, Highlight, Huyabio, Immunocellular, Medigene, Moderna, Omeros, Orexo, Rayner, Shanghai Jemincare, Soligenix, University of Montréal, Vir.
Abogen Biosciences Co. Ltd. has raised $300 million in a series C+ round to support the development of its mRNA products, specifically to support the development of its COVID-19 mRNA vaccine and expand to the global market.
RSS
