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Biomeme | August 20, 2020
Biomeme, Inc. announced today that the U.S. Food and Drug Administration (FDA) gave Biomeme’s SARS-CoV-2 Real-Time RT-PCR Test Emergency Use Authorization (EUA) for use in any lab CLIA-certified to perform high complexity testing. It is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is designed to detect the virus&r...
CELL AND GENE THERAPY
Gritstone bio | December 07, 2021
Gritstone bio, Inc. a clinical-stage biotechnology company developing next generation cancer and infectious disease immunotherapies, and CEPI, the Coalition for Epidemic Preparedness Innovations, announced the expansion of their agreement in order to support the development of a self-amplifying mRNA vaccine designed to tackle the Omicron COVID-19 variant. CEPI will provide up to $5 million in additional funding to conduct a Phase 1 clinical trial of Gritstone’s Omicron vaccine ...
GlobeNewswire | September 01, 2020
-Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc announced that the first patient was dosed last week in a Phase 2/3 study with VIR-7831 (also known as GSK4182136), a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) monoclonal antibody, for the early treatment of COVID-19 in patients who are at high risk of hospitalization. The aim of the COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) study, which will enroll approximatel...
FierceBiotech | January 21, 2020
With a new research team, outlook and more than a little help from the tech world, GSK has been quietly going about shoring up its pipeline. After seeming to turn away from oncology R&D under its old CEO Sir Andrew Witty a few years ago, new CEO and R&D head Emma Walmsley and Hal Barron, respectively, have made powering their pipeline out of the slow lane the priority. Today, GSK announced that one of its top prospects (and a drug Barron has singled out in the past) has been handed an FD...
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