Accelerate Diagnostics Announces FDA Emergency Use Authorization for COVID-19 Antibody Testing System

TUCSON, Ariz., Aug. 18, 2020 /PRNewswire/ — Accelerate Diagnostics, Inc. (NASDAQ: AXDX) and BioCheck, Inc., a privately-held San Francisco-based company focused on in vitro diagnostics, today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the BioCheck SARS-CoV-2 IgM and IgG Combo Test and fully-automated MS-Fast instrument.Continue reading

Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Yale School of Public Health for SalivaDirect, Which Uses a New Method of Saliva Sample Processing

FDA, August 15, 2020:  Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection.Continue reading

Sanofi and GSK selected for Operation Warp Speed to supply United States Government with 100 million doses of COVID-19 vaccine

  • Promising vaccine candidate selected by U.S. government’s Operation Warp Speed
  • U.S. government to provide funding up to $2.1 billion for development including clinical trials, manufacturing, scale-up and delivery of an initial 100 million doses
  • Ongoing discussions with European Commission – with France and Italy on the negotiation team – and other governments to ensure global access to a novel coronavirus vaccine
  • Sanofi and GSK today announce a collaborative effort with the U.S. government to accelerate the development and manufacturing of a COVID-19 recombinant protein-based vaccine.

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Innovators Get a Green Light from DOJ to Share Information That Could Expedite Future COVID-19 Treatments

Eli Lilly and Company, AbCellera Biologics, Amgen, AstraZeneca, Genentech, and GlaxoSmithKline  recieved approval from DOJ on July 23, 2020 to share information about manufacturing facilities and other information that could enable them to expedite the production of monoclonal antibody treatments that are determined to be safe and effective to treat COVID-19.

 

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