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GSK and Vir Biotechnology Announce the Start of the EMA Rolling Review of VIR-7831 .
Vir Biotechnology, Inc.May 7, 2021 GMT
– Rolling review will evaluate sotrovimab in adults and adolescents with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19 –
– Review will support a formal Marketing Authorization Application –
– GSK and Vir continue discussions with global regulators to make sotrovimab available to patients with COVID-19 –
LONDON and SAN FRANCISCO, May 07, 2021 (GLOBE NEWSWIRE) GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the European Medicines Agency (EMA) has started a rolling review of data on sotrovimab (previously VIR-7831), an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents (aged 12 years and o
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Vir Biotechnology and GSK Announce Start of NIH-Sponsored ACTIV-3 Trial Evaluating VIR-7831 in Hospitalized Adults with COVID-19
Vir Biotechnology and GSK Announce Start of NIH-Sponsored ACTIV-3 Trial Evaluating VIR-7831 in Hospitalized Adults with COVID-19
– Randomized, placebo-controlled, multicenter, global Phase 3 trial will investigate the safety and efficacy of VIR-7831 in hospitalized adults with COVID-19 –
SAN FRANCISCO and LONDON, Dec. 17, 2020 Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the first patient has been dosed in a new sub-trial of the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial. This trial is designed to evaluate the safety and efficacy of VIR-7831 for the treatment of hospitalized adults with COVID-19. VIR-7831 (also known as GSK4182136) is a fully human anti