Key Developments: Pfizer Inc (PFE)

PFE on New York Consolidated

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

Pfizer receives FDA accelerated approval for TRUMENBA
Wednesday, 29 Oct 2014 02:44pm EDT 

Pfizer Inc:Says the U.S. Food and Drug Administration (FDA) has granted accelerated approval of TRUMENB(meningococcal group B vaccine) for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.Approval of TRUMENBA is based on demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the United States.TRUMENBA was reviewed and approved under the FDA's Breakthrough Therapy designation and Priority Review programs.  Full Article

Pfizer Inc lowers high end of prior FY 2014 revenue guidance; narrows FY 2014 EPS guidance
Tuesday, 28 Oct 2014 07:01am EDT 

Pfizer Inc:Expects FY 2014 adjusted revenues in the range of $48.7 to $49.7 billion (previously $48.7 to $50.7 billion).Expects FY 2014 reported diluted EPS in the range of $1.50 to $1.59 (previously $1.47 to $1.62).Expects FY 2014 adjusted diluted EPS in the range of $2.23 to $2.27 (previously $2.20 to $2.30).FY 2014 revenue of $49.5 billion and EPS of $2.24 - Thomson Reuters I/B/E/S.  Full Article

Pfizer to discontinue agreement on REMOXY extended-release capsules CII
Monday, 27 Oct 2014 08:00am EDT 

Pfizer Inc:To discontinue its agreement to develop and commercialize REMOXY (oxycodone) Extended-Release Capsules CII, an investigational extended-release oral formulation of oxycodone.To return all rights, including responsibility for regulatory activities, to Pain Therapeutics, Inc.  Full Article

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

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Pfizer meningitis vaccine wins U.S. approval

- Pfizer Inc has won U.S. approval for its Trumenba vaccine against meningitis B, a potentially deadly bacterial disease that has recently caused outbreaks on college campuses, the U.S. Food and Drug Administration said on Wednesday.

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