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Recent Pfizer Press Releases
Merck KGaA, Darmstadt, Germany, and Pfizer Initiate Two Phase III Studies of Investigational Immunotherapy Avelumab in Advanced Gastric and Gastro-esophageal Junction Cancers12/9/15 11:00 am EST
DARMSTADT, Germany & NEW YORK--(BUSINESS WIRE)--Merck KGaA, Darmstadt, Germany, and Pfizer today announced the initiation of two Phase III studies of avelumab*, an investigational, fully human anti-PD-L1 IgG1 monoclonal antibody, in treating advanced or metastatic gastric/gastro-esophageal junction (GEJ) cancers, which are aggressive cancers with poor survival rates. These pivotal trials are investigating avelumab in the first-line and third-line settings, with overall survival (OS) as themore...
- Trials mark third and fourth Phase III studies of avelumab initiated by Merck KGaA, Darmstadt, Germany, and Pfizer this year
- First-line study designed to evaluate superiority of avelumab immunotherapy as a maintenance treatment for advanced or metastatic gastric/gastro-esophageal junction cancers versus continuation of first-line platinum-based chemotherapy
- Third-line study designed to evaluate avelumab immunotherapy as a third-line treatment in advanced or metastatic
gastric/gastro-esophageal junction cancers
Pfizer Announces U.S. FDA Acceptance and Priority Review of Supplemental New Drug Application for XALKORI® (crizotinib) for the Treatment of Patients with ROS1-Positive Metastatic Non-Small Cell Lung Cancer12/8/15 11:01 am ESTNEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for a supplemental New Drug Application (sNDA) for XALKORI® (crizotinib) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. In April 2015, XALKORI received Breakthrough Therapy designation by the FDA for this potential indication. If approved, XALKORI wouldmore...
Pfizer Awards More Than $4 Million in Grants to Further Clinical Research in Advanced Breast Cancer for 201512/8/15 8:00 am EST
Additional $4 million in funding to be awarded in 2016NEW YORK--(BUSINESS WIRE)--Pfizer Inc. today announced the first-ever recipients of the Advancing Science through Pfizer Investigator Research Exchange (ASPIRE) Breast Cancer Research Awards. Five grants totaling more than $4 million in funding were awarded to support clinical research projects investigating IBRANCE® (palbociclib), an oral, first-in-class inhibitor of cyclin-dependent kinases (CDKs) 4 and 6, in advanced breast cancer for 2015. Simultaneously, the companymore...
12/1/15 10:00 am ESTNEW YORK--(BUSINESS WIRE)--Pfizer Inc. invites investors and the general public to listen to a webcast of a discussion with Mikael Dolsten, President, Worldwide Research and Development, at the 27th Annual Piper Jaffray Healthcare Conference on Wednesday, December 2, 2015 at 9:00 a.m. Eastern Standard Time. To listen to the webcast, visit our web site at www.pfizer.com and click on the “27th Annual Piper Jaffray Healthcare Conference” link in the Formore...
Pfizer Reports Top-Line Results from a Phase 3 Study of LYRICA® (pregabalin) Capsules CV in Adults with Post-Traumatic Peripheral Neuropathic Pain11/25/15 8:00 am ESTNEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) announced today top-line results of a Phase 3 study evaluating the efficacy and safety of LYRICA® (pregabalin) Capsules CV in adults with chronic post-traumatic peripheral neuropathic pain. The study did not meet its primary efficacy endpoint. The study was conducted as a 15-week, double-blind, placebo-controlled, parallel group study with a primary objective to evaluate the efficacy of pregabalin in themore...
Merck KGaA, Darmstadt, Germany, and Pfizer Receive Positive Opinion for Orphan Drug Designation for Avelumab in Merkel Cell Carcinoma from EMA Committee for Orphan Medicinal Products11/25/15 4:00 am EST
DARMSTADT, Germany & NEW YORK--(BUSINESS WIRE)--Merck KGaA, Darmstadt, Germany, and Pfizer today announced that the European Medicines Agency (EMA)’s Committee for Orphan Medicinal Products (COMP) has issued a positive opinion for Orphan Drug designation (ODD) for avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, pending an official decision by the European Commission (EC), expected in December. The COMP positive opinion is for the cancer immunotherapy avelumab,more...
- EMA ODD is an important regulatory milestone for avelumab in metastatic Merkel cell carcinoma (MCC)
Pfizer Receives European Approval to Expand Use of XALKORI® (crizotinib) to First-Line Treatment of Adults with ALK-Positive Advanced Non-Small Cell Lung Cancer11/25/15 2:00 am ESTNEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) today announced that the European Commission has approved a label update to expand use of XALKORI® (crizotinib) to first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). The Summary of Product Characteristics also has been updated to include efficacy data from PROFILE 1014, which demonstrated that XALKORI significantly prolonged progression-free survival (more...
11/23/15 7:03 am EST
NEW YORK & DUBLIN--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) and Allergan plc (NYSE:AGN) today announced that their boards of directors have unanimously approved, and the companies have entered into, a definitive merger agreement under which Pfizer, a global innovative biopharmaceutical company, will combine with Allergan, a global pharmaceutical company and a leader in a new industry model – Growth Pharma, in a stock transaction currently valued at $363.63 per Allergan share, for amore...
- Creates a new global biopharmaceutical leader with best-in-class innovative and established businesses
- Enhances revenue and earnings growth profile of innovative and established businesses
- Broadens innovative pipeline with more than 100 combined mid-to-late stage programs in development
- Transaction expected to close in the second half of 2016
- Expected to be neutral to Pfizer’s Adjusted Diluted EPS1 in 2017, accretive beginning in calendar year 2018 and more than 10% accretive in 2019 with high-teens percentage accretion in 20202
- Expect combined Operating Cash Flow in excess of $25 Billion beginning in 2018
- Increased financial flexibility facilitates continued investment in the United States
- Preserves opportunity for a potential future separation of innovative and established businesses
Pfizer Reports Positive Topline Results from Phase 3 Trial Comparing XALKORI® (crizotinib) to Chemotherapy in Previously Untreated East Asian Patients with ALK-Positive Advanced Non-Small Cell Lung Cancer (NSCLC)11/18/15 8:00 am EST
Data Reinforces XALKORI Superiority Over Chemotherapy in Prolonging PFS in Patients with ALK-Positive Advanced NSCLCNEW YORK--(BUSINESS WIRE)--Pfizer Inc. announced today that PROFILE 1029, a Phase 3 study of anaplastic lymphoma kinase (ALK) inhibitor XALKORI® (crizotinib), met its primary objective of significantly prolonging progression-free survival (PFS) in previously untreated East Asian patients with ALK-positive advanced non-small cell lung cancer (NSCLC) when compared to a standard chemotherapy doublet. In this study, XALKORI was used as the first systemic therapy for patientsmore...
Merck KGaA, Darmstadt, Germany, and Pfizer Receive FDA Breakthrough Therapy Designation for Avelumab in Metastatic Merkel Cell Carcinoma11/18/15 7:00 am EST
DARMSTADT, Germany & NEW YORK--(BUSINESS WIRE)--Merck KGaA, Darmstadt, Germany, and Pfizer today announced that the US Food and Drug Administration (FDA) has granted avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Breakthrough Therapy designation for the treatment of patients with metastatic Merkel cell carcinoma (MCC) who have progressed after at least one previous chemotherapy regimen. Breakthrough Therapy designation is designed to accelerate the developmentmore...
- Breakthrough Therapy designation highlights the potential of avelumab* as a new immunotherapy for patients with metastatic Merkel cell carcinoma (MCC)
- Metastatic MCC is a devastating disease and if approved, avelumab could potentially become the first immunotherapy to treat metastatic MCC