Today, a joint meeting of the U.S. Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee and Drug Safety Risk Management Advisory Committee reviewed data from EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study) evaluating the neuropsychiatric safety of CHANTIX® (varenicline). The Committees recommended by a majority vote to remove the boxed warning regarding serious neuropsychiatric adverse events from the CHANTIXlabeling.
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Press Release Archive
Today, Pfizer Inc announced it has launched a new app, Moodivator, to help motivate and encourage the millions of adults who experience depression. Depression is one of the most common mental health disorders in the United States, as an estimated one in 15 adults (6.7%) experience at least one major depressive episode in any given year.
Pfizer Inc. announced today that Dr. Ole Isacson, a world-renowned scientist and thought leader in neurology, will become Chief Scientific Officer of the Neuroscience Research Unit and Senior Vice President, effective September 16. Dr. Isacson is a Professor of Neurology at Harvard Medical School, and will continue to serve in an educational role. He is also a founding director of the Neuroregeneration Institute at McLean Hospital. Dr. Isacson will report directly to Mikael Dolsten, President of Worldwide Research and Development.
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 Global Healthcare Conference on Tuesday, September 13, 2016 at 3:30 p.m. Eastern Daylight Time.
Pfizer Inc. invites investors and the general public to listen to a webcast of a discussion with Ian Read, Chairman and Chief Executive Officer, at the 2016 Wells Fargo Healthcare Conference on Thursday, September 8, 2016 at 12:15 p.m. Eastern Daylight Time.
Pfizer Inc. (NYSE:PFE) today announced that the European Commission has approved XALKORI® (crizotinib) for the treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC). In the European Union (EU), XALKORI is also indicated for treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced NSCLC. In March of this year, XALKORI was approved by the United States (U.S.) Food and Drug Administration for patients with metastatic NSCLC whose tumors are ROS1-positive.
Pfizer Inc. (NYSE:PFE) today announced that it has entered into an agreement with AstraZeneca to acquire the development and commercialization rights to its late-stage small molecule anti-infectives business, primarily outside the United States.
Pfizer Inc. (NYSE:PFE) and Medivation, Inc. (NASDAQ:MDVN) today announced that they have entered into a definitive merger agreement under which Pfizer will acquire Medivation, a biopharmaceutical company focused on developing and commercializing small molecules for oncology, for $81.50 a share in cash for a total enterprise value of approximately $14 billion.
Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved TROXYCA® ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules, for oral use, CII for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pfizer Inc. (NYSE:PFE) announced the publication of a new post-hoc analysis of data from three studies of VYNDAQEL in patients with mild transthyretin familial amyloid polyneuropathy (TTR-FAP). The analysis, which included patients with the Val30Met mutation treated over varying periods of up to 5.5 years, showed that treatment with VYNDAQEL initiated during the early stage of the disease resulted in minimal neurological disease progression and in preservation of body weight, which often declines as the disease progresses. VYNDAQEL was well tolerated with no new safety signals observed.
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/Q2_2016_PFE_Earnings_Press_Release_lkasdvfjlskad.pdf
Pfizer Inc. (NYSE:PFE) today announced that it has acquired Bamboo Therapeutics, Inc., a privately held biotechnology company based in Chapel Hill, N.C., focused on developing gene therapies for the potential treatment of patients with certain rare diseases related to neuromuscular conditions and those affecting the central nervous system.
Pfizer Inc. (NYSE:PFE) announced today top-line results from Oral Clinical Trials for tofAcitinib in ulceratiVE colitis (OCTAVE) Sustain, the third Phase 3 study of XELJANZ® (tofacitinib citrate) being investigated in patients with moderately to severely active ulcerative colitis (UC).
Pfizer Inc. (NYSE:PFE) and Western Oncolytics announced today that they have entered into a development collaboration, license and option agreement to advance Western Oncolytics’ novel oncolytic vaccinia virus, WO-12. Oncolytic viruses are viruses engineered to kill cancer cells while sparing healthy cells, which subsequently elicits anti-cancer immune responses. This collaboration in oncolytic virus development adds another novel technology platform to Pfizer’s cancer vaccine efforts and provides an additional tool to bolster its immuno-oncology portfolio.
PHILADELPHIA and NEW YORK CITY, July 21, 2016 -- Spark Therapeutics (NASDAQ:ONCE) and Pfizer Inc. (NYSE:PFE) announced today that the U.S.
Pfizer Inc. (NYSE: PFE) announced today that the World Health Organization (WHO) has prequalified its four-dose, multi-dose vial (MDV) presentation of Prevenar 13®* (pneumococcal polysaccharide conjugate vaccine [13 – valent, adsorbed]). WHO prequalification allows for the global use of Prevenar 13® MDV by United Nations agencies and countries worldwide that require WHO prequalification.
Pfizer Inc. (NYSE:PFE) announced today the publication of findings from two pivotal Phase 3 studies of investigational crisaborole topical ointment 2% (formerly AN2728) in the online issue of the Journal of the American Academy of Dermatology.
Pfizer Inc. (NYSE:PFE) today announced that Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) received U.S. Food and Drug Administration (FDA) approval for an expanded age indication to include adults 18 through 49 years of age, in addition to the already approved indication for adults 50 years and older, for active immunization for the prevention of pneumonia and invasive disease caused by 13 Streptococcus pneumoniae (S. pneumoniae) serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F).
Pfizer Inc. (NYSE:PFE) today announced that the S-TRAC clinical trial (Sunitinib Trial in Adjuvant Renal Cancer), a Phase 3 study of SUTENT versus placebo in the adjuvant setting, met its primary endpoint of improving disease-free survival (DFS) as determined by blinded independent central review in patients with renal cell carcinoma (RCC) who are at high risk for recurrence after surgery.
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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