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Investegate |BioNTech SE Announcements | BioNTech SE: Pfizer and BioNTech Receive FDA Advisory Committee Vote Supporting Potential First Emergency Use Authorization for Vaccine to Combat COVID-19 in the U.S.

Investegate |BioNTech SE Announcements | BioNTech SE: Pfizer and BioNTech Receive FDA Advisory Committee Vote Supporting Potential First Emergency Use Authorization for Vaccine to Combat COVID-19 in the U.S.
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BAVENCIO® Receives Positive CHMP Opinion for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma

EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada and Pfizer Inc. today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending approval of BAVENCIO ® as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma who …
– EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada and Pfizer Inc. (NYSE: PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of BAVENCIO ® (avelumab) as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy. The CHMP positive opinion will now be reviewe ....

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BioNTech SE: FDA-Beratungsausschuss unterstützt die erste U.S.-Notfallzulassung für Pfizers und BioNTechs COVID-19-Impfstoff

BioNTech SE: FDA-Beratungsausschuss unterstützt die erste U.S.-Notfallzulassung für Pfizers und BioNTechs COVID-19-Impfstoff
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BioNTech SE: Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine

BioNTech SE: Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine
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Pfizer Inc.: Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine

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Data from 43,448 participants, half of whom received BNT162b2 and half of whom received placebo, showed that the vaccine candidate was well tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose
Vaccine efficacy observed in the overall study population was also generally consistent across subgroups defined by age, gender, race, ethnicity, baseline body mass index (BMI), or presence of other underlying co-morbidities
Partial protection from the vaccine candidate appears to begin as early as 12 days after the first dose
These data were included in the requests for regulatory authorization submitted to regulatory agencies across the globe, including the U.S. Food and Drug Administration and the European Medicines Agency ....

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