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pfizer inc (PFE) Key Developments

Pfizer Inc. Seeks Acquisitions

Pfizer Inc. (NYSE:PFE) is looking at big, medium and small acquisitions, anything that fits with its current strategy to support innovative businesses, the established business and helps in growth of the company.

Pfizer to Invest $5.4 Million in Romanian Drug Plant; Plans to Transfer Part of the Production in Soborg and Aprilia

Pfizer announced it is investing $5.4 million (EUR 4.1 million) in the packaging line of its Ferrosan plant in the northwestern Romanian city of Cluj-Napoca. The company also plans to transfer part of the production in Soborg and Aprilia, as well as from third-party suppliers, to the Romanian plant. Pfizer aims to raise the capacity of the plant in Cluj-Napoca to 11 million packages in the next few years from three million packages in 2013. The upgrade and the expansion works are to be completed by the end of March 2015, it added.

Bristol-Myers Squibb Company and Pfizer Inc. Announce Results of Pre-Specified Secondary Analysis of Eliquis Phase 3 AMPLIFY-EXT Trial

Bristol-Myers Squibb Company and Pfizer Inc. announced results of a pre-specified secondary analysis of the Eliquis Phase 3 AMPLIFY-EXT trial (Apixaban after the initial Management of PuLmonary embolIsm and deep vein thrombosis with First-line therapY-EXTended Treatment). The analysis evaluated clinical and demographic predictors of all-cause hospitalization in patients with VTE, which includes deep vein thrombosis (DVT) and pulmonary embolism (PE). Results from this analysis demonstrated that during the 12-month extended treatment of VTE, Eliquis significantly reduced the risk of hospitalization versus placebo. This effect was independent of other variables including renal function, the only other significant predictor of hospitalization in the AMPLIFY-EXT population. These data were presented during an oral session in Barcelona, Spain, at the ESC Congress 2014. AMPLIFY-EXT was a randomized, double-blind, placebo-controlled extended treatment superiority study with 12 months of treatment plus one month follow-up in patients with VTE who completed six to 12 months of anticoagulation therapy. The secondary analysis presented showed that, compared with placebo, Eliquis 2.5 mg (p=0.032) and 5 mg (p=0.004) were both associated with significant reduction in all-cause hospitalization. Of the 2,486 patients included in the AMPLIFY-EXT trial, 138 patients were hospitalized at least once, including 62 (7.48%) in the placebo group (n=829), 42 (5.00%) in the Eliquis 2.5 mg group (n=840), and 34 (4.18%) in the Eliquis 5 mg group (n=813). Of the first hospitalizations in the placebo group, a total of 32 (51.6%) were attributed to VTE recurrence versus six (17.7%) in the Eliquis 5 mg group and 11 (26.2%) in the Eliquis 2.5 mg group. A total of 14 Bristol-Myers Squibb/Pfizer alliance-sponsored abstracts, including the AMPLIFY-EXT pre-specified secondary analysis were accepted for presentation at the ESC Congress 2014.

Pfizer Inc. and Protalix BioTherapeutics, Inc. Announce FDA Approval of Pediatric Indication for ELELYSO (Taliglucerase Alfa) for Injection, for Intravenous Use for the Treatment of Type 1 Gaucher Disease

Pfizer Inc. and Protalix BioTherapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) approved ELELYSO(TM) (taliglucerase alfa) for injection for pediatric patients. ELELYSO is therefore now indicated for long-term enzyme replacement therapy (ERT) for adult and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease. The safety and efficacy of ELELYSO were assessed in fourteen pediatric patients with Type 1 Gaucher disease in two clinical trials. The first trial consisted of nine patients in a 12-month, multi-center, double-blind, randomized study in treatment-naïve patients aged two to 13 years. At the end of the 12-month study, therapeutic efficacy of ELELYSO was demonstrated, as measured by a decrease in spleen and liver volume and an increase in platelet count. A second trial consisted of 5 pediatric patients aged 6 to 16 years who were switched from imiglucerase to ELELYSO. The trial was a 9-month, multi-center, open-label, single-arm study in patients who had been receiving treatment with imiglucerase at dosages ranging from 9.5 units/kg to 60 units/kg every other week for a minimum of 2 years. ELELYSO was administered for 9 months at the same dose as each patient's previous imiglucerase dose. If needed, adjustment of dosage was allowed during the study in order to maintain stability of clinical parameters. Mean spleen and liver volume, platelet count and hemoglobin value remained stable through 9 months of ELELYSO treatment. The recommended dosage of ELELSYO for treatment-naïve adult and pediatric patients four years of age and older is 60 units per kg of body weight administered every other week as a 60 to 120 minute intravenous infusion. Patients previously treated on a stable dosage of imiglucerase are recommended to begin treatment with ELELYSO at that same dosage when they switch from imiglucerase to ELELYSO. Dosage adjustments can be made based on achievement and maintenance of each patient's therapeutic goals.

Pfizer's Investigational Vaccine Candidate for Clostridium Difficile Receives U.S. Food and Drug Administration Fast Track Designation

Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company's investigational Clostridium difficile (C. difficile) vaccine candidate (PF-06425090). Currently in Phase 2 clinical development, the vaccine candidate is designed to prevent C. difficile-associated disease, which can include life-threatening diarrhea and pseudomembranous colitis. The FDA's Fast Track approach is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address an unmet medical need.


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