Global Blood Therapeutics, Inc.
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A number of companies have sought to convince the European Medicine Agency that their drug merits a fast-track regulatory review.
Gilead's remdesivir is first drug fully approved by FDA to treat COVID-19. Roche and Atea team up on an investigational direct acting antiviral while Moderna reaches the 30,000-patient enrollment target for its Phase III COVE study of the company's investigational mRNA vaccine.
The developers of three drugs are hoping the European Medicines Agency will decide that their products merit fast-tracking when they are submitted for review for potential pan-EU approval.
In an open letter to the biopharmaceutical industry, BIO lays out principles for conducting COVID-19 clinical trials and disclosing and using the data. Senator Durbin asks eight vaccine makers backed by Operation Warp Speed how they will withstand political pressure to speed up the approval process.