Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE) today announced that the Phase III JAVELIN Ovarian 200 trial evaluating avelumab* alone or in combination with pegylated liposomal doxorubicin (PLD), a type of chemotherapy, compared with PLD did not meet the prespecified primary endpoints of overall survival (OS) or progression-free survival (PFS) in patients with platinum-resistant or -refractory ovarian cancer. Signals were observed in the combination arm relative to PLD, and further analyses of the trial are warranted (HR for the primary PFS endpoint for avelumab + PLD vs PLD alone: 0.78 [repeated confidence interval (RCI): 0.587, 1.244; one-sided p-value: 0.0301]; HR for the primary OS endpoint for avelumab + PLD vs PLD alone: 0.89 [RCI: 0.744, 1.241; one-sided p-value: 0.2082]; HR for the primary PFS endpoint for avelumab alone vs PLD alone: 1.68 [RCI: 1.320, 2.601; one-sided p-value: >0.99]; HR for the primary OS endpoint for avelumab alone vs PLD alone: 1.14 [RCI: 0.948, 1.580; one-sided p-value: 0.8253]; objective response, a secondary endpoint: 13.3% [95% CI 8.8, 19.0] for avelumab + PLD; 3.7% [95% CI 1.5, 7.5] for avelumab alone; and 4.2% [95% CI 1.8, 8.1] for PLD alone). No new safety signals were observed for avelumab alone or in combination, and the safety profile for avelumab in this trial was consistent with that observed in the overall JAVELIN clinical development program. The data are currently being analyzed, and detailed results will be shared with the scientific community.
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NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved LORBRENA® [lor-BREN-ah] (lorlatinib), a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease; or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. This represents the third FDA approval Pfizer has received for an oncology treatment, including two lung cancer medicines, within two months.
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) reported financial results for third-quarter 2018 and narrowed certain 2018 financial guidance ranges.
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) announced today that it has entered into a non-exclusive clinical development agreement with Novartis (NYSE: NVS) to investigate one or more combination therapies for the treatment of non-alcoholic steatohepatitis (NASH). The companies will conduct both non-clinical and Phase 1 clinical studies of Pfizer’s investigational therapies, including an Acetyl CoA-Carboxylase (ACC) Inhibitor (PF-05221304, currently in Phase 2), a Diacylglycerol O-Acyltransferase 2 (DGAT2) Inhibitor (PF-06865571, Phase 1) and a Ketohexokinase (KHK) Inhibitor (PF-06835919, Phase 2), together with Novartis’s tropifexor, a non-bile acid, Farnesoid X receptor (FXR) agonist.
NEW YORK & INDIANAPOLIS--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced complete results from a Phase 3 study evaluating the efficacy and safety of subcutaneous administration of tanezumab, an investigational humanized monoclonal antibody, in patients with osteoarthritis (OA) pain treated for 16 weeks. The study met all three co-primary efficacy endpoints, demonstrating that among patients with moderate-to-severe OA pain of the knee or hip, both dosing regimens of tanezumab were associated with a statistically significant improvement in pain, physical function and patient’s global assessment of their OA, compared to placebo. These data were presented during a late-breaking oral session at the 2018 American College of Rheumatology/Association of Rheumatology for Health Professionals (ACR/ARHP) Annual Meeting in Chicago.
Bain Capital, LP and Pfizer Inc. (NYSE: PFE) today announced the creation of Cerevel Therapeutics, LLC (“Cerevel”), a new biopharmaceutical company focused on developing drug candidates to treat disorders of the central nervous system (CNS).
NEW YORK--(BUSINESS WIRE)--Pfizer Inc.(NYSE:PFE) today announced detailed overall survival (OS) data from the PALOMA-3 trial, which evaluated IBRANCE® (palbociclib) in combination with fulvestrant compared to placebo plus fulvestrant in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer whose disease progressed on or after prior endocrine therapy. In the study, there was a numerical improvement in OS of nearly seven months with IBRANCE plus fulvestrant compared to placebo plus fulvestrant, although this difference did not reach the prespecified threshold for statistical significance (median OS: 34.9 months [95% CI: 28.8, 40.0] versus 28.0 months [95% CI: 23.6, 34.6]; HR=0.81 [95% CI: 0.64, 1.03], 1-sided p=0.0429). These data will be presented as a late-breaking oral abstract during the Presidential Symposium at the ESMO 2018 Congress (European Society for Medical Oncology) in Munich, Germany, and simultaneously published in The New England Journal of Medicine.
Pfizer Inc. today announced that the U.S. Food and Drug Administration approved TALZENNA® (talazoparib).
Pfizer Inc. (NYSE:PFE) today announced its executive team that will
report to Albert Bourla, incoming Chief Executive Officer, coincident
with the commencement of his new role effective January 1, 2019.
Pfizer today announced the recipients of the Advancing Science through Pfizer Investigator Research Exchange (ASPIRE) Breast Cancer Research Awards. Four grants totaling more than $3 million (USD) in funding will be awarded to investigators in the United States (U.S.) to support clinical research projects involving Pfizer compounds in breast cancer.
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) today announced its Board of Directors has unanimously elected Dr. Albert Bourla, 56, Pfizer Chief Operating Officer (COO), to succeed Ian Read as CEO effective January 1, 2019. Ian Read will transition from his current role as Chairman and CEO to Executive Chairman of Pfizer’s Board of Directors.
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved VIZIMPRO® [vih-ZIM-pro] (dacomitinib), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.
NEW YORK--(BUSINESS WIRE)--The board of directors of Pfizer Inc. today declared a 34-cent fourth-quarter 2018 dividend on the company’s common stock, payable December 3, 2018, to shareholders of record at the close of business on November 9, 2018. The third-quarter 2018 cash dividend will be the 320th consecutive quarterly dividend paid by Pfizer.
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) announced today that its 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) candidate, PF-06482077, received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged 18 years and older.2 Pfizer expects to start Phase 3 trials in a few months.
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, October 30, 2018. The purpose of the call is to provide
an update on Pfizer’s results, as reflected in the company’s Third
Quarter 2018 Performance Report, to be issued that morning.
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) announced today that additional sensitivity and post-hoc analyses from the Tafamidis Phase 3 Transthyretin Amyloid Cardiomyopathy (ATTR-ACT) study provide further detail on the effect of tafamidis across wild-type, hereditary, and New York Heart Association (NYHA) class sub-groups of patients with transthyretin amyloid cardiomyopathy (ATTR-CM).1 Tafamidis is the only investigational treatment that has completed a Phase 3 trial evaluating its safety and efficacy for the treatment of ATTR-CM.1 ATTR-CM is a rare, fatal, and underdiagnosed condition associated with progressive heart failure for which there are currently no approved pharmacologic treatments.2
Pfizer Inc. (NYSE:PFE) today announced results from its Phase 2a study
of PF-06651600, an oral Janus kinase (JAK) 3 inhibitor, and PF-06700841,
a tyrosine kinase (TYK) 2/JAK1 inhibitor, compared to placebo, in
patients with moderate to severe alopecia areata (AA), an autoimmune
disease characterized by hair loss and often associated with profound
psychological consequences. Both JAK inhibitors met the primary efficacy
endpoint in improving hair regrowth on the scalp relative to baseline at
week 24 (33.6 points and 49.5 points for JAK3 and TYK2/JAK1,
respectively) as measured by the Severity of Alopecia Tool (SALT) score
(100 point scale). The findings were presented during a Late-Breaking
News session at the 27th European Academy of Dermatology and Venereology
(EADV) Congress in Paris, France.
Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE) today announced positive top-line results from the pivotal Phase III JAVELIN Renal 101 study evaluating BAVENCIO® (avelumab) in combination with INLYTA® (axitinib), compared with SUTENT® (sunitinib) as initial therapy for patients with advanced renal cell carcinoma (RCC).
Pfizer Inc. invites investors and the general public to listen to a
webcast of a discussion with Frank D’Amelio, Executive Vice President,
Business Operations, and Chief Financial Officer, at the Morgan Stanley
16th Annual Global Healthcare Conference on Thursday,
September 13, 2018 at 2:55 p.m. Eastern Daylight Time.
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) today announced its investigational oral Janus kinase 3 (JAK3) inhibitor PF-06651600 received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with alopecia areata, a chronic autoimmune skin disease that causes hair loss on the scalp, face, or body.1,2
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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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