Press Release Archive
- European Union orders 100 million additional doses of COMIRNATY® bringing total doses to 300 million for 27 EU member states
- All 300 million doses expected to be delivered in 2020 and 2021
NEW YORK & MAINZ, Germany--(BUSINESS
Supplemental New Drug Application being reviewed under FDA Real-Time Oncology Review (RTOR) and Project ORBIS pilot programs
BASEL, Switzerland and NEW YORK, Dec. 28, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced a collaboration to develop and commercialize relugolix – a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist – in oncology and women’s health in the U.S. and Canada. Pfizer will also receive an exclusive option to commercialize relugolix in oncology outside the U.S. and Canada, excluding certain Asian countries.
- U.S. government orders 100 million additional doses of the Pfizer-BioNTech COVID-19 Vaccine bringing total doses for U.S.
NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10 a.m. EST on Tuesday, February 2, 2021.
- COMIRNATY® (also known as BNT162b2) receives conditional marketing authorization from the European Commission; this milestone represents a global joint effort to advance the first authorized mRNA vaccine
- Pfizer and BioNTech are ready to immediately ship
- European Commission decision on conditional marketing authorization expected imminently
- Positive CHMP opinion follows several emergency use authorizations worldwide; committee reviewed totality of scientific evidence, including Phase 3 efficacy and safety data
- Analysis of 37 participants immunized with BNT162b2 showed a broad immune response with SARS-CoV-2-specific neutralizing antibodies, TH1 type CD4+ T cells, and strong expansion of CD8+ T cells of the early effector memory phenotype
- All vaccinated participants demonstrated neutralizing antibody as well as T cell responses. T cell responses were directed against multiple regions of the spike protein, including the RBD, suggesting immune recognition of multiple independent epitopes
- Data confirm previous findings from the U.S.
- Recommendation follows yesterday’s FDA authorization for emergency use of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2), to address the crisis
- Based on urgent need, Committee recommends Pfizer-BioNTech COVID-19 va
- U.S. FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S. immediately
- Pfizer and BioNTech previously announced an agreement with the U.S.
Rockland, MA and New York, US, December 11, 2020 – 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.
Rockland, MA and New York, US, December 11, 2020 – EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc.
Board of Directors approves quarterly cash dividend of $0.39 per share
- FDA expected to make a decision on Emergency Use Authorization in the coming days
- Positive vote based on totality of scientific evidence presented by the companies, including Phase 3 efficacy and safety data
- If authorized, BNT162b2 would b
- 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
- Vac
If approved, the vaccine will help protect adults against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia
NEW YORK--(BUSINESS WIRE)--
Subcutaneous administration demonstrates manageable safety and encouraging clinical activity
- First patient was dosed in pivotal Phase 3 AFFINE study in October 2020
- U.K. regulator, MHRA, authorizes supply of COVID-19 mRNA vaccine for emergency supply under Regulation 174; Companies are ready to deliver the first doses to the U.K.
– If approved, marstacimab has potential to be a best-in-class treatment option among novel non-factor agents –
Note: These press releases were issued in the United States and are intended as reference information for U.S. investors and journalists. The information contained in each press release was accurate at the time of issuance, and Pfizer assumes no responsibility for updating the information to reflect subsequent developments.
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