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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 1 (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.

United statesUnited kingdomSylke maasAndy widgerChuck trianoFosun pharmaEuropean commissionDrug administrationBayer animal healthExchange commissionEuropean unionEuropean medicines agencyRoche groupConditional marketing authorizationEmergency use authorizationMarketing authorization holder

Pfizer : Acquires Amplyx Pharmaceuticals

Deal expands anti-infectives pipeline with addition of novel antifungal Phase 2 candidate, Fosmanogepix Opportunity to advance Pfizer’s expertise and deep heritage in infectious disease . | April 28, 2021

Angela lukinArix bioscienceAmplyx pharmaceuticals incNational prevalence of fungal diseasesWorld health organizationDrug administrationAmplyx pharmaceuticalsGlobal health data exchangeInstitute for health metricsExchange commissionUniversity of washingtonPfizer incEnterprise associatesGlobal presidentAdage capital managementBiomed ventures

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 novel investigational asset

City ofUnited kingdomSupriya mathurAboutarix bioscienceCharlotte parryShabnam bashirEamonn nolanArix bioscienceAngela lukinMary clarkChuck trianoAmplyx pharmaceuticals incNational prevalence of fungal diseasesAmplyx pharmaceuticalsGlobal health data exchangeInstitute for health metrics

Pfizer Acquires Amplyx Pharmaceuticals

Pfizer Acquires Amplyx Pharmaceuticals
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Angela lukinEamonn nolanChuck trianoArix bioscienceAmplyx pharmaceuticals incNational prevalence of fungal diseasesWorld health organizationDrug administrationAmplyx pharmaceuticalsGlobal health data exchangeInstitute for health metricsExchange commissionUniversity of washingtonPfizer incEnterprise associatesGlobal president

Pfizer and BioNTech to Supply the European Union with 100 Million Additional Doses of COMIRNATY®

Pfizer and BioNTech to Supply the European Union with 100 Million Additional Doses of COMIRNATY®
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Andy widgerAlbert bourlaRelationssylke maasRelationsjasmina alatovicSean marettRelationschuck trianoFosun pharmaEuropean commissionBayer animal healthExchange commissionPfizer incEuropean unionRoche groupEuropean medicines agencyWall streetAdvanced purchase agreement