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Recent Pfizer Press Releases

2/19/19 10:30am EST
Ochsner Health System and Pfizer Partner to Develop Innovative Models for Clinical Trials

NEW ORLEANS & Ochsner Health System, Louisiana’s largest non-profit academic healthcare system, and Pfizer Inc (NYSE:PFE) have entered into a multi-year strategic alliance to develop innovative models for clinical trials. Through this partnership, Pfizer and Ochsner — through its innovation lab, innovationOchsner (iO), in partnership with Ochsner Research — will explore ways to enhance the clinical trial experience and ease participation in clinical research for both patients and healthcare professionals.

2/19/19 9:32am EST
Pfizer Receives European Approval for ZIRABEV™ (bevacizumab), a Biosimilar to Avastin®*

Pfizer Inc. (NYSE: PFE) today announced the European Commission (EC) has approved ZIRABEV™ for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell cancer and persistent, recurrent or metastatic carcinoma of the cervix.1,2

2/19/19 6:45am EST
Pfizer and Lilly Announce Top-line Results From Phase 3 Study of Tanezumab in Chronic Low Back Pain

Pfizer Inc. (NYSE: PFE) and Eli Lilly and Company (NYSE: LLY) today announced positive top-line results from a Phase 3 study evaluating tanezumab in patients with moderate-to-severe chronic low back pain (CLBP). In the study, treatment with tanezumab 10 mg met the primary endpoint, demonstrating a statistically significant improvement in pain at 16 weeks compared to placebo. The tanezumab 5 mg arm demonstrated a numerical improvement in pain, but did not reach statistical significance compared to placebo at the week 16 analysis. Full results from this study will be submitted for future scientific publication and presentation. Tanezumab is a monoclonal antibody that is part of an investigational class of non-opioid pain medications known as nerve growth factor (NGF) inhibitors.

2/16/19 5:10pm EST
Pivotal Phase III Data for BAVENCIO® (avelumab) Plus INLYTA® (axitinib) in Advanced Renal Cell Carcinoma Published in The New England Journal of Medicine

Darmstadt, Germany and New York, NY, February 16, 2019 – Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced the publication of results from an interim analysis of the pivotal JAVELIN Renal 101 trial online in the New England Journal of Medicine.1 The combination of BAVENCIO® (avelumab) and INLYTA® (axitinib)* significantly extended median progression-free survival (PFS) by more than five months compared with SUTENT® (sunitinib) as a first-line treatment for patients with advanced renal cell carcinoma (RCC), irrespective of PD-L1 expression (HR: 0.69 [95% CI: 0.56–0.84]; BAVENCIO+INLYTA: 13.8 months [95% CI: 11.1-NE]; SUTENT: 8.4 months [95% CI: 6.9-11.1]; p<0.001). Further, the objective response rate (ORR) was doubled with BAVENCIO+INLYTA versus SUTENT in this population (51.4% [95% CI: 46.6-56.1] vs. 25.7% [95% CI: 21.7-30.0]). The study is continuing for the other primary endpoint of overall survival (OS).

2/11/19 5:29pm EST
FDA Accepts sBLA and Grants Priority Review for BAVENCIO® (avelumab) Plus INLYTA® (axitinib) for the Treatment of Advanced Renal Cell Carcinoma

Rockland, MA and New York, NY, – EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for BAVENCIO® (avelumab) in combination with INLYTA® (axitinib)* for patients with advanced renal cell carcinoma (RCC). The application has been given a target action date in June 2019.

2/11/19 5:00pm EST
Phase 3 ARCHES Trial Shows XTANDI® (enzalutamide) Significantly Improved Radiographic Progression-Free Survival in Men with Metastatic Hormone-Sensitive Prostate Cancer

Data to be presented at the 2019 Genitourinary Cancers Symposium

NEW YORK & TOKYO--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today results from the Phase 3 ARCHES trial in men with metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer is considered metastatic once the cancer has spread outside of the prostate gland to other parts of the body.1 Men are considered hormone (or castration) sensitive if their disease still responds to medical or surgical treatment to lower testosterone levels.2

2/4/19 8:00am EST
The Union For International Cancer Control And Pfizer Announce New Phase Of Global Grants Initiative Supporting Metastatic Breast Cancer Patients

New phase of the SPARC MBC Challenge aims to expand the reach of the program to 10 additional organizations, bringing the total to 50 cancer organizations in countries around the world, including India, Canada, Mexico, Brazil, Argentina, Greece, Australia and Nigeria, among others. 

In conjunction with World Cancer Day, the Union for International Cancer Control (UICC) and Pfizer Inc. announce the third round of the Seeding Progress And Resources for the Cancer Community (SPARC): Metastatic Breast Cancer (MBC) Challenge: their pioneering grants initiative designed to support the implementation of projects worldwide that address the specific needs of women with metastatic breast cancer in local communities – many of which extend beyond treatment. 

2/1/19 9:17am EST
Pfizer Receives Positive CHMP Opinion for Vizimpro® (dacomitinib) for the First-line Treatment of Adult Patients with Locally Advanced Or Metastatic Non-Small Cell Lung Cancer with EGFR-Activating Mutations

NEW YORK--(BUSINESS WIRE)--Pfizer today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending Vizimpro® (dacomitinib) 45 mg, as monotherapy, be granted marketing authorization in the European Union (EU) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations. The CHMP’s opinion will now be reviewed by the European Commission (EC).

1/29/19 6:45am EST

PROVIDES 2019 FINANCIAL GUIDANCE Full-Year 2018 Revenues of $53.6 Billion, Reflecting 2% Operational Growth; Fourth-Quarter 2018 Revenues of $14.0 Billion, Reflecting 5% Operational Growth Full-Year 2018 Reported Diluted EPS(1) of $1.87, Adjusted Diluted EPS(2) of $3.00; Fourth-Quarter 2018 Reported Loss Per Share(1) of $0.07, Adjusted Diluted EPS(2) of $0.64 Returned $20.2 Billion Directly to Shareholders in 2018 Through Share Repurchases and Dividends; Anticipates Repurchasing Approximately $9 Billion of Shares in 2019 Provides 2019 Financial Guidance Reflects a Full Year of Revenue and Expense Contributions from Consumer Healthcare(3) Reflects Anticipated Unfavorable Impact of Foreign Exchange of Approximately $0.9 billion on Revenues and Approximately $0.06 on Adjusted Diluted EPS(2) Guidance for Adjusted Diluted EPS(2) Excludes the Impact of Gains and Losses on Equity Investments, Which Favorably Impacted 2018 Adjusted Diluted EPS(2) by $0.08 Revenue Guidance of $52.0 to $54.0 Billion and Adjusted Diluted EPS(2) Guidance of $2.82 to $2.92; Midpoints of These Ranges Imply Essentially Flat Operational Performance Compared to 2018 Excluding the Unfavorable Impact of Foreign Exchange and Net Gains on Equity Investments from 2018 Results

Pfizer Inc. (NYSE: PFE) reported financial results for fourth-quarter and full-year 2018 and provided 2019 financial guidance.

1/29/19 6:30am EST
Pfizer and Lilly Announce Top-Line Results From Second Phase 3 Study of Tanezumab in Osteoarthritis Pain

NEW YORK & INDIANAPOLIS--(BUSINESS WIRE)-- Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced positive top-line results from a Phase 3 study evaluating tanezumab 2.5 mg or 5 mg in patients with moderate-to-severe osteoarthritis (OA) pain. The tanezumab 5 mg treatment arm met all three co-primary endpoints at 24 weeks, demonstrating a statistically significant improvement in pain, physical function and the patients’ overall assessment of their OA compared to those receiving placebo. The tanezumab 2.5 mg treatment arm met two of the three protocol-defined co-primary efficacy endpoints compared to placebo, demonstrating a statistically significant improvement in pain and physical function, while patients’ overall assessment of their OA was not statistically different than placebo. Tanezumab is a humanized monoclonal antibody that is part of an investigational class of non-opioid pain medications known as nerve growth factor (NGF) inhibitors.

1/14/19 8:00am EST
US FDA Accepts Regulatory Submissions for Review of Tafamidis to Treat Transthyretin Amyloid Cardiomyopathy

—FDA grants a Priority Review based on Phase 3 ATTR-ACT study findings in ATTR-CM—

Pfizer Inc. (NYSE: PFE) announced today that the US Food and Drug Administration (FDA) accepted for filing the company’s New Drug Applications (NDAs) for tafamidis for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). Pfizer has submitted two NDAs based on two forms of tafamidis: meglumine salt and free acid. Tafamidis is the only product to complete a Phase 3 trial evaluating its efficacy, safety, and tolerability in patients with ATTR-CM, a rare, fatal, and underdiagnosed condition.1,2

1/3/19 8:30am EST
Pfizer Initiates Phase 2b/3 Clinical Trial for PF-06651600, an Oral JAK3 Inhibitor, for the Treatment of Patients with Moderate to Severe Alopecia Areata

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today the initiation of a Phase 2b/3 clinical trial for its oral JAK3 inhibitor, PF-06651600, for the treatment of patients with moderate to severe alopecia areata, a chronic autoimmune skin disease that causes hair loss on the scalp, face, or body, and currently has no approved therapies.1,2