Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted and granted Priority Review to the company’s New Drug Application for lorlatinib. Lorlatinib is an investigational . . .
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Press Release Archive
Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) and Pfizer Inc. (NYSE: PFE) announced today results from the Phase 3 PROSPER trial in patients with non-metastatic (M0) Castration-Resistant Prostate Cancer (CRPC). The results show that the use of XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) significantly reduced the risk of developing metastases or death by 71 percent compared to ADT alone.
Pfizer reported financial results for fourthquarter and full-year 2017 and provided 2018 financial guidance.
Pfizer today announced that REFLECTIONS B3281006, a comparative safety and efficacy study of PF-05280586 versus MabThera® (rituximab-EU), met its primary endpoint. PF-05280586 is being developed by Pfizer as a potential biosimilar to Rituxan® (rituximab-US)/MabThera®1.
Pfizer announced today findings from the U.S. UC Narrative survey1,2 of ulcerative colitis (UC) patients and gastroenterologists (GIs). The U.S. survey findings are an initial analysis of a subset of the UC Narrative global survey, which was developed with input from the Global UC Narrative Advisory Panel.1
Pfizer Inc. (NYSE:PFE) (“Pfizer”) today announced the expiration and results of its previously announced (i) offer to purchase for cash (the “Tender Offer”) any and all of its outstanding €2,000,000,000 5.750 per cent.
Pfizer Inc. (NYSE:PFE) today announced the creation of the Innovative Target Exploration Network (ITEN), a new, early-stage partnering model that enables collaborative relationships with select academic institutions and principal investigators around the world, to identify research projects that have the potential to deliver novel therapeutic targets and mechanisms of action to underpin future drug discovery in core areas of interest to Pfizer.
Sangamo Therapeutics, Inc. (Nasdaq: SGMO) and Pfizer Inc. (NYSE: PFE) today announced a collaboration for the development of a potential gene therapy using zinc finger protein transcription factors (ZFP-TFs) to treat amyotrophic lateral sclerosis (ALS) and frontotemporal lobar degeneration (FTLD) linked to mutations of the C9ORF72 gene.
Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pfizer Inc. (NYSE:PFE), today announced that the U.S. Food and Drug Administration (FDA) has approved STEGLATRO™(ertugliflozin) tablets, an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, and the fixed-dose combination STEGLUJAN™ (ertugliflozin and sitagliptin) tablets.
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 granted Breakthrough Therapy Designation for avelumab in combination with INLYTA® (axitinib)* for treatment-naïve patients with advanced renal cell carcinoma (RCC).
Pfizer Inc. (NYSE:PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to expand the indication for BOSULIF® (bosutinib) to include adult patients with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML).
The board of directors of Pfizer Inc. today declared a 34-cent first-quarter 2018 dividend on the company’s common stock, payable March 1, 2018, to shareholders of record at the close of business on February 2, 2018. Pfizer increased the dividend by approximately 6 percent, to 34 cents from 32 cents per share. The first-quarter 2018 cash dividend will be the 317th consecutive quarterly dividend paid by Pfizer.
Pfizer today announced the expiration and results of its previously announced offers to exchange and to repurchase any and all of its outstanding £1,500,000,000 6.500 per cent. Notes due 2038 (the “Old Notes”).
Pfizer Inc. (NYSE:PFE) announced today that the United States Food and Drug Administration (FDA) has approved XELJANZ® 5 mg twice daily (BID) and XELJANZ® XR (tofacitinib) extended release 11 mg once daily (QD) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs). XELJANZ/XELJANZ XR is the first and only Janus kinase (JAK) inhibitor approved by the FDA for both moderate to severe rheumatoid arthritis (RA) and active PsA.
Pfizer Inc. (NYSE: PFE) (“Pfizer”) today announced the pricing terms of its previously announced offers to exchange and to repurchase any and all of its outstanding £1,500,000,000 6.500 per cent. Notes due 2038 (the “Old Notes”).
Pfizer Inc. (NYSE:PFE) today announced the initiation of a Phase 3 program for its once-daily Janus kinase 1 (JAK1) inhibitor PF-04965842, to evaluate the efficacy and safety of PF-04965842 for the treatment of moderate-to-severe atopic dermatitis (AD).
Pfizer Inc. announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved IXIFI™ (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade® (infliximab) for all eligible indications of the reference product.
Pfizer Inc. (NYSE: PFE) today announced that detailed results from two pivotal Phase 3 studies of TRUMENBA® (Meningococcal Group B Vaccine) were published in the New England Journal of Medicine (NEJM). Data from both studies demonstrated that TRUMENBA, as a three-dose series, elicits a protective immune response against diverse meningococcal group B (MenB) strains representative of prevalent strains causing invasive disease in the United States and Europe.
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has extended the action date by three months for the supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib), an oral treatment under investigation for adult patients with moderately to severely active ulcerative colitis (UC).
Spark Therapeutics, a fully integrated gene therapy company dedicated to challenging the inevitability of genetic disease, and Pfizer Inc., today announced that, with a cumulative follow-up of more than 13 patient years of observation, all 11 participants in the ongoing Phase 1/2 clinical trial of investigational SPK-9001 for the treatment of patients with hemophilia B had discontinued routine infusions of factor IX concentrates and shown sustained steady-state factor IX activity levels with no serious adverse events, thrombotic events or factor IX inhibitors observed.
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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