Recent Pfizer Press Releases
Pfizer Inc. (NYSE:PFE) and Protalix BioTherapeutics, Inc. (NYSE-MKT:PLX, TASE:PLX) announced today that the U.S. Food and Drug Administration (FDA) approved ELELYSO™ (taliglucerase alfa) for injection for pediatric patients. ELELYSO is therefore now indicated for long-term enzyme replacement therapy (ERT) for adult and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease.
Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s investigational Clostridium difficile (C. difficile) vaccine candidate (PF-06425090). Currently in Phase 2 clinical development, the vaccine candidate is designed to prevent C. difficile-associated disease, which can include life-threatening diarrhea and pseudomembranous colitis.
Agreement to Combine Merck’s Investigational Anti-PD-1 Antibody Pembrolizumab and Pfizer’s Crizotinib (XALKORI®) in Clinical Trial
- Eliquis demonstrated noninferiority in the primary efficacy endpoint of recurrent symptomatic venous thromboembolism (VTE) or VTE-related death versus enoxaparin/warfarin in the AMPLIFY trial
- Eliquis demonstrated superiority in the primary safety endpoint of major bleeding versus enoxaparin/warfarin in the AMPLIFY trial
Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) has approved a Supplemental New Drug Application (sNDA) for Eliquis for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. Combined, DVT and PE are known as VTE. It is estimated that every year, approximately 900,000 Americans are affected by DVT and PE.more...
- Fourteen abstracts to be presented, including new analyses from the ARISTOTLE®, AMPLIFY® and AMPLIFY-EXT trials evaluating patients with nonvalvular atrial fibrillation (NVAF) and venous thromboembolism (VTE)
- New global health economics and outcomes research (GHEOR) assessing Eliquis cost effectiveness and real-world comparative effectiveness research will also be presented
Pfizer Inc. today announced it has completed the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for palbociclib. This NDA requests FDA approval of palbociclib, in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease.more...
Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for bivalent recombinant LP2086 (rLP2086), the company’s vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 through 25 year olds. The FDA has also granted Priority Review designation for the BLA, providing an anticipated Prescription Drug User Fee Act (PDUFA) action date of February 14, 2015.more...
Pfizer Inc. (NYSE:PFE) today announced that the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein] (PCV13) for routine use to help protect adults aged 65 years and older against pneumococcal disease, which includes pneumonia caused by the 13 pneumococcal serotypes included in the vaccine. Specifically, the ACIP voted to recommend the following:more...
Application Includes Data from Pfizer’s Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA)
Pfizer Inc. (NYSE:PFE) announced today that the European Medicines Agency (EMA) has accepted Pfizer’s application seeking to expand the indication for Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) in adults to include the prevention of pneumonia caused by the 13 pneumococcal serotypes contained in the vaccine.
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Pfizer Inc. (NYSE:PFE) announced today that the members of Rascal Flatts, the most-awarded country music band of the past decade, are among the thousands of people who choose Nexium® 24HR every day since becoming available without a prescription for frequent heartburn this past May.
Pfizer Inc. today announced that it has entered into a definitive agreement to acquire Baxter International Inc.’s portfolio of marketed vaccines for $635 million. As part of the transaction, Pfizer will also acquire a portion of Baxter’s facility in Orth, Austria, where these vaccines are manufactured.more...
- In the AMPLIFY trial, Eliquis was shown to be non-inferior for the treatment of recurrent venous thromboembolism (VTE)/VTE-related death and was statistically superior in the primary safety endpoint of major bleeding vs. enoxaparin/warfarin
- In the AMPLIFY-EXT trial, Eliquis demonstrated a superior reduction in VTE/all-cause death with no statistical difference in major bleeding events vs. placebo
- Second-Quarter 2014 Reported Revenues(1) of $12.8 Billion
- Second-Quarter 2014 Adjusted Diluted EPS(2) of $0.58, Reported Diluted EPS(1) of $0.45
- Repurchased $2.9 Billion of Common Stock to Date in 2014
- Reaffirmed 2014 Adjusted Diluted EPS(2) Guidance; Updated Certain Other 2014 Financial Guidance Components
- Expects to Complete U.S. Regulatory Submission for Palbociclib in Advanced Breast Cancer in August 2014
Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) today announced that the first patient has been enrolled into a Phase IV clinical trial called EMANATE (Eliquis evaluated in acute cardioversion coMpared to usuAl treatmeNts for AnTicoagulation in subjEcts with NVAF) assessing the effectiveness and safety of Eliquis in patients with nonvalvular atrial fibrillation (NVAF) undergoing cardioversion. Eliquis is currently approved to reduce the risk of stroke and systemic embolism in patients with NVAF.more...
Pfizer’s Get Old Campaign Challenges Conventional Attitudes about Aging
New social study finds 4.2 million tweets a year on aging; topic of health grew 48% in 2014 over 20132
Life expectancy continues to climb — up to more than 81 years for women and 76 years for men3 – but many of us have concerns around aging. Pfizer is challenging Americans to address their #FOGO – Fear of Getting Old – as the next phase of Get Old, an initiative by Pfizer around aging, encouraging honest conversations and celebrating getting “old” at whatever stage of life you are.more...
InnoPharma Has Established Track Record in the Development of Hard-to-Make, Differentiated, Sterile Injectable Products
Portfolio of 10 Approved Products and Pipeline of More Than 30 Products in Development; 19 Pending Approval with the United States Food and Drug Administration
Pfizer Inc. (NYSE:PFE) and InnoPharma, Inc., a privately held pharmaceutical development company, today announced that they have entered into an agreement under which Pfizer will acquire InnoPharma.more...
Once-Weekly Prophylaxis Treatment with BeneFIX® Significantly Reduced Annualized Bleeding Rate Compared to On-Demand Treatment
Pfizer Inc. (NYSE:PFE) today announced the positive results of a Phase 3 study comparing a prophylaxis regimen of BeneFIX® Coagulation Factor IX (Recombinant) 100 IU/kg once-weekly to on-demand treatment in people with moderately severe to severe hemophilia B. The top-line results of the study showed that the primary study endpoint was met and hemophilia B patients taking once-weekly BeneFIX (100 IU/Kg) showed a statistically significant reduction in the annualized bleeding rate (ABR) (P < 0.0001) relative to on-demand treatment with BeneFIX.more...
CliniWorks announced a strategic alliance between its Israeli subsidiary CliniWorks (Israel) Ltd. (“CliniWorks Israel”) and Pfizer Inc. (“Pfizer”) to jointly advance the parties’ respective capabilities in working with healthcare provider organizations to identify and close clinical or quality gaps to improve population health.more...