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.
One of the biggest concerns at the Nov. 30 meeting of the FDA’s Antimicrobial Drugs Advisory Committee is that, if Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s antiviral drug, molnupiravir, is authorized for use in treating mild to moderate COVID-19 in patients at high risk of progressing to severe disease, it might be used too broadly, given its potential risks.
Whether it’s the highly mutated Omicron variant emerging in South Africa as biopharma researchers scramble to create custom-made vaccines in record time or the institutional mandates juxtaposed with waning vaccine immunity and the ongoing ups and downs of cases and deaths, the SARS-CoV-2 virus continues to dig its ugly spikes into an uncertain and anxious world.
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