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Recent Pfizer Press Releases
Pfizer Receives Positive CHMP Opinion in Europe for XELJANZ® (tofacitinib citrate) for the Treatment of Moderate to Severe Active Rheumatoid Arthritis1/27/17 7:00 am ESTNEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending XELJANZ® (tofacitinib citrate) 5 mg twice daily (BID) for the treatment of patients with moderate to severe active rheumatoid arthritis (RA). The CHMP’s opinion will now be sent to the European Commission (EC) for final decision. If approved, XELJANZ in combinationmore...
Pfizer Announces Positive Top-Line Results from Phase 2 Study of Investigational Clostridium difficile Vaccine for the Prevention of C. difficile Infection1/26/17 8:00 am EST
Pfizer’s C. difficile Vaccine Candidate to Commence Phase 3 Study in First Half of 2017
C. difficile is an Increasing Worldwide Concern Associated with Approximately 29,000 Annual Deaths in the U.S. AloneNEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) announced today that the Phase 2 study evaluating the Company’s Clostridium difficile (C. difficile) vaccine candidate, PF-06425090, provided positive data, based on a pre-planned interim analysis. The randomized Phase 2 study (NCT02561195) examined the safety, tolerability, and immunogenicity of the vaccine in healthy adults 65 to 85 years of age. Pfizer’s vaccine candidate is designed to help prevent C. difficilemore...
Pfizer Announces Positive Top-Line Results from the Comparative REFLECTIONS B538-02 Study for PF-06410293, a Potential Biosimilar to Humira®1 (adalimumab)1/5/17 8:30 am EST
Marks Pfizer’s third proposed biosimilar pipeline molecule 2 to report positive top-line data results within the past four monthsNEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) today announced that the comparative, confirmatory REFLECTIONS B538-02 study met its primary objective by demonstrating equivalent efficacy as measured by the American College of Rheumatology 20 (ACR20) response rate at Week 12. This trial is evaluating the efficacy, safety, and immunogenicity of PF-06410293 compared to Humira® (adalimumab), each taken in combination with methotrexate, in patients with moderate to severemore...
1/3/17 11:00 am ESTNEW 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, January 31, 2017. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s Fourth Quarter 2016 Performance Report, to be issued that morning. To view and listen to the webcast and view the Performance Report, visit our web sitemore...
FDA Accepts Supplemental New Drug Application for Pfizer’s IBRANCE® (palbociclib) in HR+, HER2- Metastatic Breast Cancer12/21/16 8:00 am EST
sNDA includes data from Phase 3 PALOMA-2 trial to support conversion from accelerated approval to regular approvalNEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for its first-in-class CDK 4/6 inhibitor, IBRANCE® (palbociclib). The sNDA supports the conversion of the accelerated approval of IBRANCE in combination with letrozole to regular approval and includes data from the Phase 3 PALOMA-2 trial, which evaluated IBRANCE as initial therapy inmore...
Pfizer Receives Approval in the European Union for Nimenrix™ (Meningococcal Group A, C, W-135, and Y Conjugate Vaccine) in Infants Six Weeks of Age and Older12/19/16 7:00 am ESTNEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) announced today the European Commission (EC) has approved an expanded indication for Nimenrix™ (meningococcal group A, C, W-135, and Y conjugate vaccine) for active immunization against invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W-135, and Y (MenACWY) in infants as early as six weeks of age. Nimenrix is now the first and only MenACWY conjugate vaccine in the European Union (EU)more...
FDA Approves Removal Of Boxed Warning Regarding Serious Neuropsychiatric Events From CHANTIX® (varenicline) Labeling12/16/16 2:09 pm EST
Labeling Revisions Also Include Updates to Corresponding Warning and Addition of Clinical Data on Superior Efficacy of CHANTIX Compared to Bupropion or Nicotine Patch 1
Labeling Revisions May Further Encourage Smokers and Healthcare Providers to Discuss Smoking Cessation Treatment OptionsNEW YORK--(BUSINESS WIRE)--Pfizer announced today that the U.S. Food and Drug Administration (FDA) approved updates to the CHANTIX® (varenicline) labeling, including removal of the boxed warning regarding serious neuropsychiatric events. The removal of the boxed warning is based on the outcomes of EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study), the largest smoking cessation clinical trial in patients without and with a history of psychiatricmore...
Pfizer and Astellas Announce Top-Line Results from Phase 4 PLATO Trial of XTANDI® (enzalutamide) Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer12/14/16 4:15 pm ESTNEW YORK & TOKYO--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (TSE:4503) today announced the Phase 4 PLATO study, evaluating the efficacy and safety of continued treatment with XTANDI ® (enzalutamide), plus abiraterone acetate and prednisone as compared to treatment with abiraterone acetate and prednisone alone, did not meet its primary endpoint of improvement in progression-free survival (PFS) in patients with chemotherapy-naïve metastatic castration-more...
Pfizer and Avillion Announce Positive Top-Line Results for Phase 3 BFORE Study of BOSULIF for First-Line Treatment of Philadelphia Chromosome Positive Chronic Myeloid Leukemia12/5/16 8:00 am ESTNEW YORK--(BUSINESS WIRE)--Today, Pfizer Inc. and its partner Avillion LLP announced results from the Phase 3 BFORE ( B osutinib trial in F irst line chr O nic myelogenous leukemia t RE atment) trial demonstrating superiority of BOSULIF® (bosutinib) over imatinib as a first-line treatment for patients with chronic phase Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). The study met its primary endpoint of major molecular response (MMR) at 12more...
12/1/16 8:00 am ESTNEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) announced today positive top-line results of a study that evaluated the use of LYRICA® (pregabalin) Capsules CV and Oral Solution CV as adjunctive therapy for pediatric epilepsy patients four to 16 years of age with partial onset seizures. Results showed that adjunctive treatment with LYRICA 10 mg/kg/day resulted in a statistically significant reduction in seizure frequency versus placebo, the primary efficacy endpoint.more...