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Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pfizer Inc. (NYSE:FE), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review three New Drug Applications (NDAs) for medicines containing ertugliflozin, an investigational SGLT2 inhibitor in development to help improve glycemic control in adults with type 2 diabetes: one for monotherapy, one for the fixed-dose combination of ertugliflozin and JANUVIA® (sitagliptin), and one for the fixed-dose combination of ertugliflozin and metformin.
Pfizer Inc. (NYSE:PFE) today announced the pricing of a debt offering consisting of four tranches of notes:
€1,250,000,000 aggregate principal amount of floating rate notes due 2019
€1,000,000,000 aggregate principal amount of 0.000% notes due 2020
€1,000,000,000 aggregate principal amount of 0.250% notes due 2022
€750,000,000 aggregate principal amount of 1.000% notes due 2027
Pfizer Inc. invites investors and the general public to view and listen to a webcast of a presentation by John Young, Group President, Pfizer Essential Health, at the Cowen and Company 37th Annual Healthcare Conference on Tuesday, March 7, 2017 at 11:20 a.m. Eastern Standard Time. To view and listen to the webcast, visit our web site at www.pfizer.com and click on the “Cowen and Company 37th Annual Healthcare Conference” link in the For Investors section located on the lower right-hand corner of that page.
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, and Pfizer Inc. today announced that the US Food and Drug Administration (FDA) has accepted for Priority Review EMD Serono's Biologics License Application (BLA) for avelumab* as a treatment for patients with locally advanced or metastatic urothelial carcinoma (mUC) with disease progression on or after platinum-based therapy. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 27, 2017, for avelumab in this indication.
Pfizer Inc. (NYSE: PFE) today announced the pricing of $1,065,000,000 aggregate principal amount of 4.20% notes due 2047. This offering is expected to besold to professional institutional investors in Taiwan, with application to be made to list the notes on the Taipei Exchange.
Pfizer intends to use the net offering proceeds for general corporate purposes, including to repay a portion of its outstanding commercial paper.
The closing of the offering is expected to occur on March 17, 2017, subject to satisfaction of customary closing conditions.
Pfizer Inc. today announced the election of Ronald E. Blaylock to its Board of Directors, effective immediately. Mr. Blaylock was also appointed to the Corporate Governance and Science and Technology Committees of Pfizer’s Board.
Pfizer Inc. (NYSE:PFE) today announced that a Biologics License Application (BLA) for inotuzumab ozogamicin has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). Inotuzumab ozogamicin is being evaluated for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Data announced jointly today by Pfizer Inc.
Pfizer Inc. (NYSE:PFE) announced today top-line results from ORAL Strategy, a Phase 3B/4 study of XELJANZ® (tofacitinib citrate) 5mg twice daily (BID) in the treatment of moderate to severe rheumatoid arthritis (RA). ORAL Strategy is the first trial to compare a JAK inhibitor as monotherapy or in combination with methotrexate (MTX) versus adalimumab (Humira) plus MTX in MTX inadequate responders using ACR50 at Month 6 as the primary endpoint. There were three comparisons,which found:
Pfizer Inc. (NYSE:PFE) announced today that the U.S.
Nationally-recognized relationship expert and author, Logan Levkoff, Ph.D., has partnered with Pfizer Inc. (NYSE:PFE) to fill a void in information available to people living with chronic diseases: relationship advice. Levkoff will address the topics of relationships and intimacy for those living with a chronic condition, like rheumatoid arthritis (RA), on the newly re-launched Arthritis.com site. The website is a place where people living with a chronic illness can find inspiration, lifestyle advice, tools, and disease information.
Please find Pfizer’s press release and associated financial tables, including reconciliations of certain GAAP reported to non-GAAP adjusted information, at the following hyperlink: http://www.pfizer.com/system/files/presentation/Q4_2016_PFE_Earnings_Pre...
Pfizer Inc. (NYSE:PFE) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending XELJANZ® (tofacitinib citrate) 5 mg twice daily (BID) for the treatment of patients with moderate to severe active rheumatoid arthritis (RA). The CHMP’s opinion will now be sent to the European Commission (EC) for final decision.
Pfizer Inc. (NYSE:PFE) announced today that the Phase 2 study evaluating the Company’s Clostridium difficile (C. difficile) vaccine candidate, PF-06425090, provided positive data, based on a pre-planned interim analysis. The randomized Phase 2 study (NCT02561195) examined the safety, tolerability, and immunogenicity of the vaccine in healthy adults 65 to 85 years of age. Pfizer’s vaccine candidate is designed to help prevent C.
Pfizer Inc. (NYSE:PFE) today announced that the comparative, confirmatory REFLECTIONS B538-02 study met its primary objective by demonstrating equivalent efficacy as measured by the American College of Rheumatology 20 (ACR20) response rate at Week 12. This trial is evaluating the efficacy, safety, and immunogenicity of PF-06410293 compared to Humira® (adalimumab), each taken in combination with methotrexate, in patients with moderate to severe rheumatoid arthritis. PF-06410293 is being developed as a potential biosimilar to Humira.
Pfizer Inc. (NYSE:PFE) 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 31, 2017. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s Fourth Quarter 2016 Performance Report, to be issued that morning.
Pfizer Inc. invites investors and the general public to listen to a webcast of a discussion with Albert Bourla, Group President, Pfizer Innovative Health, Frank D’Amelio, Executive Vice President, Business Operations, and Chief Financial Officer, and Mikael Dolsten, President, Worldwide Research and Development, and at the 35th Annual J.P. Morgan Healthcare Conference on Tuesday, January 10, 2017 at 10:30 a.m. Pacific Standard Time. To listen to the webcast, visit our web site at www.pfizer.com and click on the “35th Annual J.P.
Pfizer Inc. (NYSE:PFE) today announced that it has completed the acquisition of the development and commercialization rights to AstraZeneca’s late-stage small molecule anti-infective business, primarily outside the United States.
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for its first-in-class CDK 4/6 inhibitor, IBRANCE® (palbociclib).
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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