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.
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Press Release Archive
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
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.
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).
Pfizer Inc. (NYSE: PFE) reported financial results for fourth-quarter and full-year 2018 and provided 2019 financial guidance.
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.
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
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
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. invites investors and the general public to listen to a webcast of a discussion with Albert Bourla, Chief Operating Officer, and Mikael Dolsten, President, Worldwide Research and Development, at the 37th Annual J.P. Morgan Healthcare Conference on Monday, January 7, 2019 at 8:30 a.m. Pacific Standard Time. Effective January 1, 2019, Albert Bourla will become Chief Executive Officer.
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. invites investors and the general public to listen to a webcast of a discussion with Albert Bourla, Chief Operating Officer, at the Goldman Sachs 11th Annual Healthcare CEOs Unscripted: A View from the Top on Thursday, January 3, 2019 at 10:15 a.m. Eastern Standard Time. Effective January 1, 2019, Albert Bourla will become Chief Executive Officer.
Darmstadt, Germany, and New York, US, December 21, 2018 – Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE) today announced that data from a planned interim analysis of the Phase III JAVELIN Ovarian 100 study of avelumab* did not support the study’s initial hypothesis, and therefore the alliance made the decision to terminate the trial in alignment with the independent Data Monitoring Committee.
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) announced today that the Phase 2b trial STRIVE (STaphylococcus aureus SuRgical Inpatient Vaccine Efficacy) evaluating the company’s investigational Staphylococcus aureus (S. aureus) multi-antigen vaccine (PF-06290510) is being discontinued due to futility. This decision is based on a recommendation from an independent Data Monitoring Committee (DMC), composed of external experts, after conducting a pre-planned interim analysis.
TOKYO & NEW YORK--(BUSINESS WIRE)--Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced that the Phase 3 ARCHES trial evaluating XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC) met its primary endpoint, significantly improving radiographic progression-free survival (rPFS) versus ADT alone. The preliminary safety analysis of the ARCHES trial appears consistent with the safety profile of XTANDI in previous clinical trials in castration-resistant prostate cancer (CRPC). Detailed results will be submitted for presentation at an upcoming medical congress.
Pfizer Inc. (NYSE: PFE) and GlaxoSmithKline plc (NYSE:GSK) today announced they have entered into an agreement to create a premier global consumer healthcare company with robust iconic brands. The Boards of Directors of both companies have unanimously approved the transaction under which Pfizer will contribute its consumer healthcare business to GlaxoSmithKline’s existing consumer healthcare business. The 2017 global sales for the combined business were approximately $12.7 billion.
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. 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 29, 2019. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s Fourth Quarter 2018 Performance Report, to be issued that morning.
The board of directors of Pfizer Inc. today declared a 36-cent first-quarter 2019 dividend on the company’s common stock, payable March 1, 2019, to shareholders of record at the close of business on February 1, 2019. Pfizer increased the dividend by approximately 6 percent, to 36 cents from 34 cents per share. The first-quarter 2019 cash dividend will be the 321st consecutive quarterly dividend paid by Pfizer.
Pfizer Inc. (NYSE:PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for ZIRABEV™ (bevacizumab), a potential biosimilar to Avastin (bevacizumab).1 ZIRABEV is a monoclonal antibody 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.2
Pfizer Inc. (NYSE:PFE) announced today the initiation of a Phase 3 program for its 20-Valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged 18 years and older.
Pfizer Inc. (NYSE:PFE) announced today at the American Society of Hematology Annual Meeting that the REFLECTIONS B328-06 study, a comparative safety and efficacy study of PF-05280586 versus Rituxan®/MabThera® (rituximab-EU)i, met its primary endpoint of overall response rate (ORR) at Week 26 of the 52-week study.1
Pfizer Inc. (NYSE:PFE) today announced that it has signed licensing agreements with AbbVie, resolving all global intellectual property matters for Pfizer’s proposed adalimumab biosimilar. Under the terms of the agreements, AbbVie grants Pfizer a non-exclusive patent license for the use and sale of Pfizer’s proposed adalimumab biosimilar for many countries around the world.
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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