Pfizer (PFE), BioNTech (BNTX) Start Rolling Submission to FDA for Booster - Bloomberg

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Pfizer (PFE) Appoints Aamir Malik as Chief Business Innovation Officer

August 26, 2021 8:00 AM EDT

Pfizer Inc. (NYSE: PFE) today announced that Aamir Malik has joined the company as Executive Vice President and Chief Business Innovation Officer. Mr. Malik will be a member of Pfizers Executive Leadership Team reporting to Chairman and Chief Executive Officer, Albert Bourla. Mr. Malik joins Pfizer from McKinsey & Company, where he most recently served as the Managing Partner responsible for the firms U.S. operations. Previously, he led the firms Global Pharmaceuticals & Medical Products practice.

Mr. Malik succeeds John Young, Executive Vice... More

Pfizer (PFE) and BioNTech(BTNX) Partner With Eurofarma Laboratórios to Manufacture COVID-19 Vaccine in Latin America

August 26, 2021 6:47 AM EDT

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with Eurofarma Laboratórios SA, a Brazilian biopharmaceutical company, to manufacture COMIRNATY® (COVID-19 Vaccine, mRNA) for distribution within Latin America.

Eurofarma will perform manufacturing activities within Pfizers and BioNTechs global COVID-19 vaccine supply chain and manufacturing network, which will now span four continents and include more than 20 manufacturing facilities. To facilitate Eurofarmas involvement in the process, technical transfer, on-site development, and equipment installation activities will begin immediately.... More

Pfizer (PFE), BioNTech (BNTX) Confirm Rolling Submission of sBLA to U.S. FDA for Booster Dose of Covid-19 Vaccine

August 25, 2021 12:09 PM EDT

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the approval of a booster (third) dose of COMIRNATY® (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older. The companies intend to complete submission of the sBLA by the end of this week.

The sBLA includes data from a Phase 3 clinical trial of 306 participants 18-55 years of age who received a booster (third)... More