Press Release Archive
Bristol-Myers Squibb Company (NYSE: BMY) and 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 ELIQUIS® (apixaban) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is August 25, 2014.
Pfizer Inc. announced that it has settled its litigation against Teva Pharmaceuticals, USA Inc., relating to Pfizer’s patent covering the use of Viagra® to treat erectile dysfunction (sildenafil citrate 25, 50, and 100 mg tablets), which expires in April 2020 (including pediatric exclusivity).
Pfizer Inc. (NYSE: PFE) named Albert Bourla as Group President of the Vaccines, Oncology and Consumer Healthcare business effective January 1, 2014.
The board of directors of Pfizer Inc. today declared a 26-cent first-quarter 2014 dividend on the company’s common stock, payable March 4, 2014, to shareholders of record at the close of business on February 7, 2014. Pfizer increased the dividend by more than 8 percent, to 26 cents from 24 cents per share.
Pfizer Inc. (NYSE: PFE) today announced an update of its clinical trial data access policy that will simplify and broaden access to information gathered in Pfizer-sponsored clinical trials. The updated policy builds upon and expands the company’s established methods of clinical trial information sharing, including Pfizer’s long track record of submitting for publication results from all interventional clinical trials in patients and its pioneering efforts to provide clinical trial results and data to study participants.
Pfizer Inc. (NYSE: PFE) today announced that a wholly-owned Polish subsidiary of Pfizer has acquired the rights to Polocard, a low-dose aspirin (acidum acetylsalicylicum), and the leading over-the-counter (OTC) brand for heart attack prevention in Poland, from ZF Polpharma SA.
With more than 40 million Americans expected to travel this holiday season, facing the increased chance of catching a cough, cold or flu while on the road, Robitussin® has introduced Maximum Strength Cough + Chest Congestion DM, its new liquid-filled capsules that control cough on-the-go. This formulation not only harnesses the power of Maximum Strength Robitussin® cough liquid, but is a convenient option for those hitting the road or boarding a plane this holiday season.
Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Pfizer’s XALKORI® (crizotinib) regular approval for the treatment of patients with metastatic ALK-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. XALKORI was previously granted accelerated approval in August 2011 due to the critical need for new agents for people living with ALK-positive NSCLC.
Pfizer Inc. announced today that it has entered into an agreement with GSK to explore the anti-cancer efficacy and the safety of GSK’s trametinib (GSK1120212) combined with Pfizer’s palbociclib (PD-0332991) in a Phase I/II study (Study 200344) in patients with advanced/metastatic melanoma.
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib citrate) to include additional Patient-Reported Outcomes (PRO) data in the label. These additional data show improvement in patients receiving XELJANZ based on health-related outcome measures reported by patients, including vitality, role emotional, physical function, bodily pain, social function, mental health, role physical and general health, which are the eight domains of the Medical Outcomes Study Short-Form (36-Item) Health Survey (SF-36).
Pfizer Inc. (NYSE: PFE) today announced that Wyeth LLC, its wholly owned subsidiary, has notified The Bank of New York Mellon, as trustee under the applicable indenture, of its election to fully redeem all of its outstanding 5.500% Notes due February 1, 2014 (CUSIP No. 983024AE0) (the “Notes”). The aggregate principal amount of Notes currently outstanding is $1.75 billion. The redemption date for the Notes will be December 16, 2013 (the “Redemption Date”).
Pfizer Inc. (NYSE:PFE) announced today top-line results from a Phase 3B/4 study of RAPAMUNE® (sirolimus) evaluating kidney transplant patients who transitioned from tacrolimus-based therapy (TAC) to RAPAMUNE® 3 to 5 months after transplant. The primary endpoint of the study was not achieved as there was not a statistically significant difference in renal function improvement between patients who continued receiving TAC and those who switched to RAPAMUNE®.
Former U.S. President Jimmy Carter joined Pfizer (NYSE:PFE) today to commemorate the 15th Anniversary of the International Trachoma Initiative (ITI), an independent, not-for-profit program dedicated to the elimination of blinding trachoma as a public health concern. Trachoma is an infectious eye disease that is a leading cause of blindness and suffering in the poorest regions of the world. Pfizer has provided hundreds of millions of doses of the antibiotic Zithromax® (azithromycin) to help the global campaign wipe out blinding trachoma by the year 2020.
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved a Prior Approval Supplement for EMBEDA® (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules CII.
People who have an irregular heartbeat known as atrial fibrillation (AFib) not caused by a heart valve problem may not know the facts about the condition. Emmy®-nominated game show host Howie Mandel didn’t either. That is, until he was diagnosed with the condition and became one of approximately 5.8 million people in the United States
The board of directors of Pfizer Inc. today declared a 24-cent fourth-quarter 2013 dividend on the company’s common stock, payable December 3, 2013, to shareholders of record at the close of business on November 8, 2013. The fourth-quarter 2013 cash dividend will be the 300 consecutive quarterly dividend paid by Pfizer.
Pfizer Inc. (NYSE: PFE) announced today that, having achieved technical milestones related to manufacturing, it will continue the development program for Remoxy® (oxycodone) Extended-Release Capsules CII. Following guidance received from the U.S. Food and Drug Administration (FDA) earlier this year, Pfizer will proceed with the additional clinical studies and other actions required to address the Complete Response Letter received in June 2011.
Pfizer Inc. (NYSE: PFE) announced today top-line results from two phase 3b, placebo-controlled studies with Lyrica® (pregabalin) Capsules CV in patients with fibromyalgia (FM) and painful diabetic peripheral neuropathy (DPN), respectively. The fibromyalgia study, A0081275 met its primary endpoint, showing a reduction in pain associated with fibromyalgia in patients who were treated concurrently with antidepressant therapy for comorbid depression. Separately, the painful DPN study, A0081269 did not meet its co-primary endpoints by sufficiently reducing DPN pain and DPN pain on walking compared to placebo.
Pfizer Inc. (NYSE: PFE) announced today that the European Commission approved updates to the Summary of Product Characteristics (SmPC) for the company’s pneumococcal conjugate vaccine Prevenar 13[*] (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]), regarding its use in certain populations at high risk of pneumococcal disease. The updated label now includes information describing the use of the vaccine in preterm infants, children and adolescents with sickle cell disease who were previously vaccinated with the 23-valent pneumococcal polysaccharide vaccine, and adults with human immunodeficiency virus (HIV) infection who were previously vaccinated with the 23-valent pneumococcal polysaccharide vaccine.
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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