MAINZ, Germany & BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”), and Pfizer Inc. (NYSE: PFE) today disclosed additional details of their collaboration to advance candidates from BioNTech’s mRNA vaccine program, previously announced on March 17, 2020.
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Pfizer Inc. (NYSE: PFE) today announced important advances in the battle against the global COVID-19 pandemic.
The application is based on positive results from an interim analysis of the Phase III JAVELIN Bladder 100 trial, which met its primary endpoint of overall survival (OS).
Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI? (encorafenib) in combination with cetuximab (marketed as ERBITUX?) for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAFV600E mutation, as detected by an FDA-approved test, after prior therapy.1 The approval is based on results from the BEACON CRC trial, the only Phase 3 trial to specifically study patients with previously treated metastatic CRC with a BRAFV600E mutation.
Pfizer Inc. (NYSE: PFE) today announced that its 2020 Annual Meeting of Shareholders will be held in a virtual-only format due to continued public health concerns related to coronavirus / COVID-19, and to support the health and well-being of our shareholders and other meeting participants. The previously announced date and time of the meeting, April 23, 2020 at 9:00 a.m. Eastern Daylight Time, will not change. Shareholders can find additional details regarding participation in the 2020 Annual Meeting at www.meetingcenter.io/280277443. The password for the meeting is PFE2020.
Pfizer Inc. (NYSE: PFE) and The Pfizer Foundation today announced the commitment of $40 million in medical and charitable cash grants to help combat the global health effects of the COVID-19 pandemic in the U.S. and around the world. The donation addresses the urgent needs of partners who are working to slow the spread of the virus within communities and strengthen vulnerable healthcare systems against future public health threats. Pfizer is also responding to patient and healthcare provider needs during this unprecedented time by evolving its U.S. Patient Assistance Program and donating additional critical medicines and vaccines in the U.S. and around the world.
Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has approved RUXIENCE? (rituximab), a monoclonal antibody (mAb) and biosimilar to MabThera? (rituximab), for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), and pemphigus vulgaris (PV).1,2,3
Pfizer Inc. (NYSE: PFE) today announced the election of Dr. Susan Desmond-Hellmann to its Board of Directors, effective immediately. Dr. Desmond-Hellmann, age 62, was also appointed to the Governance & Sustainability Committee and the Science and Technology Committee of Pfizer’s Board.
KENILWORTH, N.J. & NEW YORK & INDIANAPOLIS--(BUSINESS WIRE)--Merck & Co., Inc., (NYSE: MRK), Pfizer Inc. (NYSE: PFE), and Eli Lilly and Company (NYSE: LLY) today announced medical service volunteer programs to enable employees who are licensed medical professionals to aid in the fight against COVID-19 while maintaining their base pay.
Pfizer Inc. (NYSE: PFE) today announced the completion of a $1.25 billion ten-year “sustainability” bond paying interest semi-annually of 2.625 percent and maturing April 1, 2030. This is Pfizer’s first-ever sustainability bond and a first for a biopharmaceutical company.
HERTFORDSHIRE, England & PITTSBURGH & Mylan N.V. (Nasdaq: MYL) and Pfizer Inc. (NYSE: PFE) today announced that due to the unprecedented circumstances surrounding the COVID-19 pandemic, including associated delays in the regulatory review process, the proposed transaction involving Mylan and Upjohn, a division of Pfizer, is now anticipated to close in the second half of 2020.
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for EUCRISA? (crisaborole) ointment, 2%, extending the lower age limit from 24 months down to 3 months in children with mild-to-moderate atopic dermatitis (AD), also known as eczema.1 EUCRISA was previously approved for use in adults and children 2 years of age and older.2 This supplemental approval makes EUCRISA the first and only steroid-free, topical prescription medication for mild-to-moderate AD patients as young as 3 months of age.
Pfizer Inc. (NYSE: PFE) announced today that given the unique circumstances of the COVID-19 pandemic and Pfizer’s responsibility to prioritize the health and safety of colleagues and invited guests, the company will reschedule its planned March 31, 2020 Investor Day for a later date.
Pfizer Inc. (NYSE:PFE) today announced top-line results from one of its Phase 3 studies (NCT03760146), which evaluated the safety and immunogenicity of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate in adults 18 years of age or older not previously vaccinated against pneumococcal disease. The primary immunogenicity objectives of non-inferiority for the 20 serotypes included in 20vPnC in adults 60 years of age and older at one month after vaccination were met for all serotypes in common with licensed Prevnar 13? (pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) and six of the seven additional serotypes when compared to a licensed pneumococcal polysaccharide vaccine (PPSV23); one of the new seven serotypes missed noninferiority criteria by a small margin.1 Secondary immunogenicity objectives for adults 18-59 years old compared to those 60-64 years old met non-inferiority for all 20 serotypes. The safety objectives were met in adults 18 years of age or older demonstrating that the safety and tolerability of 20vPnC were comparable to licensed pneumococcal vaccines. Based on prior discussions with regulators, these data are expected to meet licensure criteria.
Pfizer Inc. (NYSE:PFE) announced today that JADE COMPARE (B7451029) met its co-primary efficacy endpoints. The Phase 3 study evaluated the safety and efficacy of abrocitinib, an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor, in adults with moderate to severe atopic dermatitis who were also on background topical therapy. The study also included an active control arm, dupilumab, a biologic treatment administered by subcutaneous injection, compared with placebo.
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. EDT on Tuesday, April 28, 2020. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s First Quarter 2020 Performance Report, to be issued that morning.
NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the companies have agreed to a letter of intent regarding the co-development and distribution (excluding China) of a potential mRNA-based coronavirus vaccine aimed at preventing COVID-19 infection. The companies have executed a Material Transfer and Collaboration Agreement to enable the parties to immediately start working together.
Pfizer today issued a five-point plan calling on the biopharmaceutical industry to join the company in committing to unprecedented collaboration to combat COVID-19.
Rockland, MA and New York, US, March 13, 2020 – EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced an update from the Phase III JAVELIN Head and Neck 100 study evaluating avelumab in addition to chemoradiotherapy (CRT) versus standard-of-care CRT in patients with untreated locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). The alliance has accepted the recommendation of the independent Data Monitoring Committee (DMC) to terminate the JAVELIN Head and Neck 100 trial, as the study is unlikely to show a statistically significant improvement in the primary endpoint of progression-free survival (PFS) based on a preplanned interim analysis. A detailed analysis of the Phase III JAVELIN Head and Neck 100 study is being conducted and study findings will be shared with the scientific community.
Pfizer Inc. (NYSE: PFE) today announced the election of Dr. Susan Hockfield to its Board of Directors, effective immediately. Dr. Hockfield, age 68, was also appointed to the Regulatory and Compliance Committee and the Science and Technology Committee of Pfizer’s Board.
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.