There are now two FDA-backed monoclonal antibody COVID-19 treatments after the agency granted Glaxosmithkline plc (GSK) emergency use authorization (EUA) for single-dose sotrovimab to treat mild to moderate COVID-19 in adults and children as young as 12. Vir Biotechnology Inc. collaborated on the program.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Beyond Air, Circassia Group, Exthera Medical, Gensight Biologics, Henry Schein, Innova Medical Group, Medical Diagnostic Laboratories, Mesi, Mirati Therapeutics, Neovasc, Qiagen, Sharp Packaging, Retractable Technologies, Udg Healthcare.
With the global COVID-19 pandemic and variants raising expectations about the need for booster shots, more companies are jumping into the vaccine space. But unless those sponsors have been engaging “in an ongoing manner” with the U.S. FDA on developing the manufacturing process and clinical trial program for their vaccine candidates, their emergency use authorization (EUA) requests may be denied, according to a new FDA guidance on EUAs for COVID-19 vaccines.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Immunitybio, Larimar, Mezzion, PTC, Revance, Travere.
A new study by Laboratory Corp. of America Holdings (Labcorp) has found that nearly 9 in 10 COVID-19 patients continue to have antibodies to SARS-CoV-2 proteins 10 months after infection. Published in The Lancet-affiliated Eclinicalmedicine, the study provides real-world evidence of the persistence of SARS-CoV-2 antibodies in infected individuals, though the authors said more research is needed to determine if, and to what degree, protection against reinfection persists.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Biological Laboratories, Amg International, Choicespine, Guard Medical, Ihealthscreen, Jenavalve, Quidel, Unity HA, Uroviu.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adventhealth, Alpha Imaging, Anpac Bio-Medical Science, Burstiq, Confluent Medical Technologies, Drawbridge Health, F-Star Therapeutics, GT Medical Technologies, Henry Schein, Inivata, Isoplexis, Jarvis Analytics, Ka Imaging, Lifebit Biotech, Mount Sinai Genomics, Nexstim, Novocure, Paige, Promis Neurosciences, Quest Diagnostics, Rulestar, Thorne Healthtech, Waters.
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