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BioNTech SE: Pfizer and BioNTech Submit Request to Expand Conditional Marketing Authorization of COMIRNATY in the EU to Adolescents


BioNTech SE: Pfizer and BioNTech Submit Request to Expand Conditional Marketing Authorization of COMIRNATY in the EU to Adolescents
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(Nasdaq: BNTX) today announced they have submitted a variation to the Conditional Marketing Authorization (CMA) in the European Union (EU) to the European Medicines Agency (EMA) for the Pfizer-BioNTech vaccine COMIRNATY
(BNT162b2) to request an extension of the indication for use in adolescents 12 to 15 years of age. If EMA approves the variation, the amended CMA will be valid in all 27 member states of the EU. The companies have already submitted a similar request to the U.S. Food and Drug Administration (FDA) for the Emergency Use Authorization (EUA) and plan to request additional amendments with other regulatory authorities worldwide. ....

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Investegate |Arix Bioscience PLC Announcements | Arix Bioscience PLC: Amplyx Pharmaceuticals acquired by Pfizer


About Arix Bioscience plc
Arix Bioscience plc is a global venture capital company focused on investing in and building breakthrough biotech companies around cutting-edge advances in life sciences.
 
We collaborate with exceptional entrepreneurs and provide the capital, expertise and global networks to help accelerate their ideas into important new treatments for patients. As a listed company, we are able to bring this exciting growth phase of our industry to a broader range of investors. www.arixbioscience.com
 
Pfizer Acquires Amplyx Pharmaceuticals
Opportunity to advance Pfizer s expertise and deep heritage in infectious disease
NEW YORK Pfizer Inc. (NYSE: PFE) announced today that it has acquired Amplyx Pharmaceuticals, Inc., a privately-held company dedicated to the development of therapies for debilitating and life-threatening diseases that affect people with compromised immune systems. Amplyx s lead compound, Fosmanogepix (APX001), is a nove ....

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