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Showing posts with the label Biotech & Pharma.

News | Biotech & Pharma : Pfizer, BioNTech's coronavirus vaccines get FDA's 'fast track' status

2minutes - Source: CNBC Albert Bourla, Pfizer Gian Ehrenzeller | Keystone | AP Two experimental coronavirus vaccines jointly developed by German biotech firm BioNTech  and U.S. pharmaceutical giant Pfizer  have received ‘fast track’ designation from the U.S. drug regulator, the companies said on Monday. The candidates, BNT162b1 and BNT162b2, are the most advanced of at least four vaccines being assessed by the companies in ongoing trials in the United States and Germany. Pfizer’s shares were up about 2% and U.S.-listed shares of BioNTech were up about 6% before the bell. Earlier this month, the companies said BNT162b1 showed potential against the virus and was found to be well tolerated in early-stage human trials. Early data from the German trial of BNT162b1 are expected to be released in July, the companies said. If the ongoing studies are successful, and the vaccine candidate receives regulatory approval, the companies said they e