Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved ABRILADA™ (adalimumab-afzb), as a biosimilar to Humira® (adalimumab),1 for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.2 For full details of indications please see the approved label.
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Press Release Archive
PRINCETON, N.J. & The Bristol-Myers Squibb-Pfizer Alliance today announced the initiation of a new randomized, controlled study, GUARD-AF (ReducinG stroke by screening for UndiAgnosed atRial fibrillation in elderly inDividuals). The study seeks to determine if earlier detection of atrial fibrillation (AFib) through screening in previously undiagnosed men and women at least 70 years of age in the U.S. ultimately impacts the rate of stroke, compared to usual standard medical care. This study will also assess potential bleeding leading to hospitalization, and therefore provide an evaluation of net clinical benefit or harm. AFib is the most common type of significant irregular heart rhythm, and it is estimated that 8 million people in the U.S. will be affected by AFib in 2019.i,ii AFib is a significant risk factor for stroke; stroke risk is up to five times higher in people with AFib than in those without it.iii,iv AFib can often go undetected, as it can be asymptomatic,i and some studies suggest that more than 25 percent of people who have an AFib-related stroke find out they have AFib after a stroke.v
HERTFORDSHIRE, England & PITTSBURGH & Mylan N.V. (NASDAQ: MYL) and Pfizer Inc. (NYSE: PFE) today announced that the name of the new company to be formed by the planned combination of Mylan and Upjohn, a division of Pfizer, will be Viatris (pronounced ‘viǝ-trīs).
Pfizer Inc. (NYSE: PFE) announced today that positive results from a Phase 3 investigational study of tofacitinib in children and adolescents aged two to less than 18 with juvenile idiopathic arthritis (JIA) will be presented for the first time during a late-breaking oral presentation at the American College of Rheumatology (ACR)/Association of Rheumatology Professionals (ARP) Annual Meeting (November 8-13, Atlanta, GA). The study of tofacitinib in JIA is investigative and JIA is not an FDA-approved indication for XELJANZ. Pfizer has plans to file for the indication in 2020.
Rockland, MA and New York, US, November 8, 2019 – EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced topline results of the Phase III JAVELIN Gastric 100 study evaluating avelumab as first-line maintenance therapy following induction chemotherapy in patients with unresectable, locally advanced or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) cancer versus continuation of chemotherapy or best supportive care. While the study showed clinical activity for avelumab in this setting, it did not meet the primary endpoints of superior overall survival compared with the standard of care in the overall intent-to-treat population (n=499; HR: 0.91; 95% CI: 0.74, 1.11) or the PD-L1–positive population (n=54; HR: 1.13; 95% CI: 0.57, 2.23).
Pfizer Inc. (NYSE:PFE) reported financial results for third-quarter 2019 and updated certain components of its 2019 financial guidance.
- EU approval based on JAVELIN Renal 101 trial results demonstrating significant improvement in progression-free survival with BAVENCIO in combination with axitinib compared with sunitinib
- Combination regimen approved across all IMDC prognostic risk groups and irrespective of PD-L1 expression
MIAMI and NEW YORK, October 21, 2019 – OPKO Health Inc. (NASDAQ: OPK) and Pfizer Inc. (NYSE: PFE) announced today that the global Phase 3 trial evaluating somatrogon dosed once-weekly in pre-pubertal children with growth hormone deficiency (GHD) met its primary endpoint of non-inferiority to daily GENOTROPIN® (somatropin) for injection, as measured by annual height velocity at 12 months.
PRINCETON, N.J., NEW YORK, N.Y. and SAN FRANCISCO, C.A., October 17, 2019 – The Bristol-Myers Squibb-Pfizer Alliance and Fitbit today announced at the TIME 100 Health Summit in New York
Pfizer Inc. (NYSE: PFE) announced today complete results from a Phase 3, 12-week, pivotal study (JADE MONO-1) in patients aged 12 and older with moderate to severe atopic dermatitis (AD). Abrocitinib, an investigational oral Janus kinase 1 (JAK1) inhibitor, met all the co-primary and key secondary endpoints, which were related to skin clearance and itch relief compared to placebo. Safety data showed that both evaluated doses of abrocitinib (200mg and 100mg) were well tolerated and were consistent with a companion study (JADE MONO-2) from the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program. The results were shared as a Late-Breaking presentation at the 28th Congress of the European Academy of Dermatology and Venereology (EADV) taking place October 9-13, 2019 in Madrid, Spain.
Akcea Therapeutics, Inc. (NASDAQ: AKCA), a majority-owned affiliate of Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) and Pfizer Inc. (NYSE:PFE), today announced that the companies have entered into a worldwide exclusive licensing agreement for AKCEA-ANGPTL3-LRx, an investigational antisense therapy being developed to treat patients with certain cardiovascular and metabolic diseases.
Pfizer Inc. (NYSE: PFE) today announced detailed results from the interim analysis of the Phase 3 BEACON CRC trial evaluating the combination of BRAFTOVI® (encorafenib), MEKTOVI® (binimetinib), and cetuximab (BRAFTOVI Triplet), in patients with advanced BRAFV600E-mutant metastatic colorectal cancer (mCRC), following one or two lines of therapy. The results show significant improvements in overall survival (OS) and objective response rates (ORR) for the BRAFTOVI Triplet and BRAFTOVI Doublet combination (BRAFTOVI and cetuximab), compared to cetuximab plus irinotecan-containing regimens (Control), and provide analysis of the efficacy and safety of the BRAFTOVI Triplet compared to the BRAFTOVI Doublet. These data will be presented today during a late-breaking oral session at the 2019 European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain, and simultaneously published online in The New England Journal of Medicine (NEJM). Pfizer intends to submit the results of the BEACON CRC trial for marketing approval in the U.S. in the fourth quarter of 2019. The use of BRAFTOVI, MEKTOVI and cetuximab for the treatment of patients with BRAFV600E-mutant mCRC is investigational and not approved by the FDA.
Following its regularly scheduled meeting, the Board of Directors of Pfizer Inc. (NYSE:PFE) today announced that Executive Chairman of the Board Ian C. Read has chosen to retire on December 31, 2019, and that it has unanimously elected Pfizer’s Chief Executive Officer (CEO), Dr. Albert Bourla, to succeed him as Chairman of the Board of Directors effective January 1, 2020. Bourla will also retain the CEO role.
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today positive top-line results from a second Phase 3 pivotal study evaluating the efficacy and safety of its investigational oral Janus kinase 1 (JAK1) inhibitor, abrocitinib, in patients aged 12 and older with moderate to severe atopic dermatitis (AD). This is the second monotherapy trial in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program (B7451013, or JADE MONO-2). Pfizer announced positive top-line results from the first trial in the JADE program (B7451012, or JADE MONO-1) on May 15, 2019. Complete results from JADE MONO-1 will be presented as a late-breaking abstract at a major upcoming European scientific meeting in Madrid in October 2019.
• Analyses from the Phase III JAVELIN Renal 101 study support efficacy of BAVENCIO plus axitinib across multiple subgroups of patients with advanced renal cell carcinoma (RCC)
• Abstracts highlight data on BAVENCIO as a monotherapy and in combination in multiple advanced cancers
The Board of Directors of Pfizer Inc. today declared a 36-cent fourth-quarter 2019 dividend on the company’s common stock, payable December 2, 2019, to holders of the Common Stock of record at the close of business on November 8, 2019. Pfizer maintained the dividend from the third-quarter at 36 cents per share. The fourth-quarter 2019 cash dividend will be the 324th consecutive quarterly dividend paid by Pfizer.
Pfizer Inc. (NYSE: PFE) today announced the presentation of four IBRANCE® (palbociclib) real-world analyses. The studies support the effectiveness of IBRANCE combination therapy in everyday clinical practice and provide additional insights on its use in certain patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). The posters will be presented at the European Society for Medical Oncology (ESMO) Congress 2019 in Barcelona, Spain on Sunday, September 29.
Pfizer Inc. (NYSE: PFE) and Flatiron Health today announced an expanded strategic collaboration to further integrate and increase the use of real-world data in Pfizer’s development of innovative targeted cancer medicines.
Rockland, MA and New York, US, September 20, 2019 – EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of BAVENCIO® (avelumab) in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) is presenting data across its industry-leading oncology portfolio, including company-sponsored and collaborative research studies, spanning 11 therapies in 22 types of cancer, at the European Society for Medical Oncology (ESMO) Congress to be held in Barcelona, Spain, September 27 - October 1, 2019. Data from nearly 50 abstracts involving Pfizer cancer medicines will illustrate the diversity of the portfolio and the company’s cutting-edge scientific approach. For the first time, this will include data presentations on compounds from the acquisition of Array Biopharma Inc.
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.