Key Developments: Pfizer Inc (PFE)

PFE on New York Consolidated

24 Oct 2014
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Latest Key Developments (Source: Significant Developments)

Pfizer Inc declares fourth-quarter 2014 dividend
Thursday, 23 Oct 2014 04:05pm EDT 

Pfizer Inc:Declares 26-cent fourth-quarter 2014 dividend on the company's common stock.Payable Dec. 2, of record at the close of business on Nov. 7.  Full Article

Pfizer Inc approves abuse deterrent labeling for EMBEDA (morphine sulfate and naltrexone hydrochloride) extended-release capsules CII
Friday, 17 Oct 2014 04:38pm EDT 

Pfizer Inc:Says the United States Food and Drug Administration (FDA) has approved an updated label for EMBEDA (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, for oral use, CII, to include abuse-deterrence studies.Says updated label states that EMBEDA has properties that are expected to reduce abuse via the oral and intranasal (i.e., snorting) routes when crushed.However, abuse of EMBEDA by these routes is still possible.Says updated label also includes data from a human abuse potential study of intravenous (IV) morphine and naltrexone to simulate crushed EMBEDA.However, it is unknown whether the results with simulated crushed EMBEDA predict a reduction in abuse by the IV route until additional postmarketing data are available.EMBEDA is indicated 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 expects EMBEDA will be available in the U.S. in early 2015.  Full Article

Pfizer Inc Announces FDA Acceptance Of Palbociclib New Drug Application
Monday, 13 Oct 2014 08:00am EDT 

Pfizer Inc:Says the New Drug Application (NDA) for palbociclib has been accepted for filing and granted Priority Review by the United States Food and Drug Administration (FDA).This NDA requests FDA approval of palbociclib, with letrozole, as a first-line treatment for postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous treatment for advanced disease.The submission is based on the final results of PALOMA-1, a randomized, Phase 2 trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients.  Full Article

Pfizer Inc gets patent for Voriconazole in India-Business Standard
Sunday, 12 Oct 2014 10:14am EDT 

Pfizer Inc:Has received a patent for its anti-fungal drug Voriconazole, which it is selling in US under the brand name Vfend-Business Standard.  Full Article

Pfizer Inc to present safety and immunogenicity data from A Phase 2 study of investigational meningococcal group B vaccine, Bivalent rLP2086, Co-administered with licensed human papillomavirus vaccine
Wednesday, 8 Oct 2014 08:00am EDT 

Pfizer Inc:Announces it will present results of Phase 2, randomized study to evaluate co-administration of company's investigational meningococcal group B vaccine, bivalent recombinant LP2086 (rLP2086), with licensed quadrivalent human papillomavirus vaccine (HPV4), at IDWeek 2014 in Philadelphia.Data demonstrated immune responses to both vaccines were generated after concomitant administration of bivalent rLP2086 and HPV4.Prespecified noninferiority criteria were met for bivalent rLP2086 antigens studied and three of four antigens for HPV4.Phase 2, randomized study evaluated co-administration of licensed quadrivalent human papillomavirus vaccine (HPV4) with bivalent rLP2086.Says an investigational vaccine against meningococcal disease caused by Neisseria meningitidis serogroup B in healthy individuals 11 through 17 years of age at multiple sites across U.S.  Full Article

Pfizer Inc completes acquisition Of InnoPharma Inc
Thursday, 25 Sep 2014 08:00am EDT 

Pfizer Inc:Completes acquisition of the pharmaceutical development company, InnoPharma, Inc., following receipt of United States regulatory approval from all government authorities required by agreement and other closing conditions.  Full Article

MedGenesis enters into agreement with Pfizer Inc for potential treatments for Parkinson's Disease
Tuesday, 16 Sep 2014 09:00am EDT 

MedGenesis Therapeutix Inc:Entered into an agreement with Pfizer Inc.To license its glial cell line-derived neurotrophic factor (GDNF) protein and convection enhanced delivery (CED) technology to be used in research for potential treatments for Parkinson's disease.  Full Article

Bristol-Myers Squibb Company and Pfizer Inc announces results of secondary analysis of Eliquis Phase 3 AMPLIFY-EXT trial
Saturday, 30 Aug 2014 05:04am EDT 

Bristol-Myers Squibb Company and Pfizer Inc:Announces results of a pre-specified secondary analysis of the Eliquis Phase 3 AMPLIFY-EXT trial (A pixaban after the initial M anagement of P u L monary embol I sm and deep vein thrombosis with F irst-line therap Y - EXT ended 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).Says results from this analysis demonstrated that during the 12-month extended treatment of VTE, Eliquis significantly reduced the risk of hospitalization versus placebo.Says this effect was independent of other variables including renal function, the only other significant predictor of hospitalization in the AMPLIFY-EXT population.  Full Article

Pfizer and Protalix BioTherapeutics announce FDA approval of pediatric indication for ELELYSO
Thursday, 28 Aug 2014 01:15pm EDT 

Pfizer Inc and Protalix BioTherapeutics, Inc:Says U.S. Food and Drug Administration (FDA) approved ELELYSO (taliglucerase alfa) for injection for pediatric patients.ELELYSO is indicated for long-term enzyme replacement therapy for adult and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease.  Full Article

Pfizer Inc's investigational vaccine candidate for clostridium difficile receives U.S. Food and Drug Administration fast track designation
Thursday, 28 Aug 2014 08:00am EDT 

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.  Full Article

Deals of the day-Mergers and acquisitions

Oct 24 - The following bids, mergers, acquisitions and disposals were reported by 2000 GMT on Friday:

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