Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved RUXIENCE™ (rituximab-pvvr), a biosimilar to Rituxan® (rituximab),1 for the treatment of adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).2
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Press Release Archive
Sangamo Therapeutics, Inc. (NASDAQ: SGMO), a genomic medicine company, and Pfizer, Inc. (NYSE: PFE) today announced updated results from the Phase 1/2 Alta study evaluating investigational SB-525 gene therapy for severe hemophilia A.
Pfizer Inc. (NYSE: PFE) today announced the successful completion of its acquisition of the privately held clinical-stage biotechnology company Therachon Holding AG. Under the terms of the transaction, Pfizer acquired Therachon for $340 million with an additional $470 million in additional payments contingent on the achievement of key milestones in the development and commercialization of TA-46. TA-46 is an investigational medicine for the treatment of achondroplasia, a genetic condition and the most common form of short-limb dwarfism. There are currently no approved treatment options for achondroplasia.
Pfizer Inc. (NYSE:PFE) today announced top-line results from a Phase 4 study (CrisADe CARE 1) which showed that crisaborole ointment, 2%, was well-tolerated in children aged 3 months to less than 24 months with mild to moderate atopic dermatitis (AD), also known as eczema. The data from the trial are supportive of the primary study objective to examine the safety of crisaborole ointment, 2%, in this patient population, and are consistent with previous clinical trial experience.1 Crisaborole ointment, 2%, is currently approved in select countries for mild to moderate AD in patients two years of age and older.2,3,4,5
Pfizer Inc. (NYSE: PFE) announced today that a Phase 3 study to assess the efficacy and safety of intravenous (IV) sildenafil when added to inhaled nitric oxide (iNO) for the treatment of newborns with Persistent Pulmonary Hypertension (PPHN) did not meet its primary efficacy endpoint. Treatment with IV sildenafil when added to iNO did not result in a statistically significant reduction in treatment failure rate or time on iNO compared to treatment with iNO alone. Sildenafil is not indicated for the treatment of PPHN. The study was part of an EU Pediatric Investigational Plan (PIP).
Pfizer Inc. (NYSE:PFE) will present initial Phase 1b clinical data on PF-06939926, an investigational gene therapy to potentially treat Duchenne muscular dystrophy (DMD) at the 25th Annual Parent Project Muscular Dystrophy (PPMD) Connect Conference in Orlando, FL. These are preliminary data drawn from a small number of participants in an ongoing study.
Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration(FDA) has approved ZIRABEV™ (bevacizumab-bvzr), a biosimilar to Avastin® (bevacizumab),1 for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent or metastatic cervical cancer.2
Pfizer Inc. (NYSE:PFE) today announced the election of Dr. Scott Gottlieb to its Board of Directors, effective immediately. Dr. Gottlieb, age 47, was also appointed to the Regulatory and Compliance Committee and the Science and Technology Committee of Pfizer’s Board.
The Board of Directors of Pfizer Inc. today declared a 36-cent third-quarter 2019 dividend on the company’s common stock, payable September 3, 2019, to holders of the Common Stock of record at the close of business on August 2, 2019. Pfizer maintained the dividend from the second-quarter at 36 cents per share. The third-quarter 2019 cash dividend will be the 323rd consecutive quarterly dividend paid by Pfizer.
Pfizer Inc. (NYSE:PFE) today announced that the European Commission approved TALZENNA® (talazoparib), an oral poly (ADP-ribose) polymerase (PARP) inhibitor, as monotherapy for the treatment of adult patients with germline breast cancer susceptibility gene (gBRCA)1/2-mutations, who have human epidermal growth factor receptor 2-negative (HER2-) locally advanced (LA) or metastatic breast cancer (MBC). Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor-positive (HR+) breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.1 This approval follows the medicine’s approval by the U.S. Food and Drug Administration (FDA) in October 2018.
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. EDT on Tuesday, July 30, 2019. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s Second Quarter 2019 Performance Report, to be issued that morning.
NEW YORK & BOULDER, Colo.--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and Array BioPharma Inc. (NASDAQ: ARRY) today announced that they have entered into a definitive merger agreement under which Pfizer will acquire Array, a commercial stage biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule medicines to treat cancer and other diseases of high unmet need. Pfizer has agreed to acquire Array for $48 per share in cash, for a total enterprise value of approximately $11.4 billion. The Boards of Directors of both companies have approved the merger.
Pfizer Inc. (NYSE:PFE) announced today positive results from ORAL Shift, a Phase 3b/4 study in adult patients with moderately to severely active rheumatoid arthritis (RA). Patients who achieved low disease activity (LDA) with XELJANZ® (tofacitinib) extended release (XR) 11 mg once daily (QD) plus methotrexate (MTX) after a 24-week open-label run-in period, were randomized to evaluate the efficacy and safety of XELJANZ XR 11 mg QD as monotherapy after MTX withdrawal compared with XELJANZ XR with continued MTX. The study demonstrated non-inferiority of MTX withdrawal with XELJANZ XR 11 mg QD compared to XELJANZ XR 11 mg QD plus MTX at week 48 as measured by the primary endpoint, the change in the Disease Activity Score (DAS28-4[ESR]) from randomization at week 24 to the end of the double-blind MTX withdrawal phase at week 48. The study results will be presented during a late-breaking oral session at the Annual European Congress of Rheumatology (EULAR 2019) in Madrid, Spain (15 June).
Pfizer Inc. (NYSE: PFE) announced today that Jeff Settleman, Ph.D., will join the company as Senior Vice President and Group Head of Oncology Research & Development, leading all early oncology research, from discovery to proof of concept clinical studies. Dr. Settleman, a leader in molecularly targeted cancer therapeutics, the epigenetics of cancer drug resistance, and personalized cancer medicine, will report directly to Mikael Dolsten, M.D., Ph.D., Chief Scientific Officer and President of Worldwide Research, Development and Medical at Pfizer, and will be based in La Jolla, California.
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today that a Phase 3 study to assess the use of LYRICA® (pregabalin) as adjunctive therapy for epilepsy patients 5 to 65 years of age with primary generalized tonic-clonic (PGTC) seizures did not meet its primary endpoint. Treatment with LYRICA did not result in a statistically significant reduction in seizure frequency versus placebo. Lyrica is not indicated in any population for the treatment of PGTC seizures. The study was a post-marketing commitment to the U.S. Food and Drug Administration (FDA).
Pfizer Inc. (NYSE:PFE) will present data across its industry-leading oncology portfolio, covering multiple tumor types and mechanisms of action at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from May 31-June 4, 2019. Data will highlight Pfizer’s cutting-edge approach, expertise in precision medicine and work in immunotherapy combinations, including company-sponsored and collaborative research studies.
Pfizer Inc. (NYSE: PFE) announced today positive top-line results from a Phase 3 pivotal study (B7451012) evaluating the efficacy and safety of its investigational oral Janus kinase 1 (JAK1) inhibitor, abrocitinib (PF-04965842), in patients aged 12 and older with moderate to severe atopic dermatitis (AD).
Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) in combination with INLYTA® (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This is the first FDA approval for an anti-PD-L1 therapy as part of a combination regimen for patients with advanced RCC.
Pfizer Inc. announced today the opening of a new 175,000 square-foot manufacturing facility in Andover, Mass. Pfizer’s Andover site houses commercial manufacturing and product development functions, with colleagues dedicated to the development and production of high-quality complex biologics and vaccines. With its modular and flexible design, the newly opened Andover Clinical Manufacturing Facility (ACMF) will expand the capacity for Pfizer’s BioTherapeutics Pharmaceutical Sciences organization to manufacture clinical supplies.
NEW YORK & BASEL, Switzerland--(BUSINESS WIRE)-- Pfizer (NYSE: PFE) today announced that it has entered into a definitive agreement to acquire all the shares of Therachon Holding AG, a privately-held clinical-stage biotechnology company focused on rare diseases, with assets in development for the treatment of achondroplasia and short bowel syndrome (SBS). Under the terms of the agreement, Pfizer will acquire Therachon for $340 million upfront with an additional $470 million in additional payments contingent on the achievement of key milestones in the development and commercialization of TA-46 for the treatment of achondroplasia, a genetic condition and the most common form of short-limbed dwarfism. Achondroplasia can result in serious cardiovascular, neurological and metabolic complications for approximately 250,000 people worldwide. There are currently no approved treatments for achondroplasia.
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.