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Pfizer Inc (PFE.N)

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Latest Key Developments (Source: Significant Developments)

BioMarin Receives $20 Mln In Milestone Payments From Pfizer For Talazoparib
Thursday, 7 Jun 2018 

June 7 (Reuters) - Biomarin Pharmaceutical Inc ::BIOMARIN RECEIVES MILESTONE PAYMENTS FROM PFIZER FOR TALAZOPARIB.BIOMARIN PHARMACEUTICAL INC - COMPANY RECEIVED $20 MILLION IN MILESTONE PAYMENTS FROM PFIZER INC.BIOMARIN PHARMACEUTICAL INC - MILESTONE PAYMENTS ARE PART OF AGREEMENT MADE WITH MEDIVATION, INC. WHEN CO PURCHASED TALAZOPARIB.BIOMARIN PHARMA - MILESTONE PAYMENTS TRIGGERED BY U.S. FDA ACCEPTANCE OF PFIZER'S NEW DRUG APPLICATION (NDA) SUBMISSION FOR TALAZOPARIB.BIOMARIN PHARMA - MILESTONE PAYMENTS ALSO TRIGGERED BY EUROPEAN MEDICINES AGENCY ACCEPTANCE OF PFIZER'S SUBMISSION OF MAA FOR TALAZOPARIB.  Full Article

U.S. FDA And European Medicines Agency Accept Regulatory Submissions For Review Of Talazoparib For Metastatic Breast Cancer Patients With An Inherited BRCA Mutation
Thursday, 7 Jun 2018 

June 7 (Reuters) - Pfizer Inc ::U.S. FDA AND EUROPEAN MEDICINES AGENCY ACCEPT REGULATORY SUBMISSIONS FOR REVIEW OF TALAZOPARIB FOR METASTATIC BREAST CANCER PATIENTS WITH AN INHERITED BRCA MUTATION.PFIZER INC - U.S. NEW DRUG APPLICATION GRANTED FDA PRIORITY REVIEW.PFIZER INC - SUBMISSIONS BASED ON DATA FROM EMBRACA, LARGEST PHASE 3 TRIAL PERFORMED TO DATE OF A PARP INHIBITOR IN BRCA-MUTATED MBC.PFIZER INC - PRESCRIPTION DRUG USER FEE ACT (PDUFA) GOAL DATE FOR A DECISION BY FDA IS IN DECEMBER 2018.  Full Article

Pfizer's Xalkori Receives FDA Breakthrough Therapy Designation In Two New Indications
Tuesday, 29 May 2018 

May 29 (Reuters) - Pfizer Inc ::PFIZER’S XALKORI® (CRIZOTINIB) RECEIVES FDA BREAKTHROUGH THERAPY DESIGNATION IN TWO NEW INDICATIONS.PFIZER- FDA GRANTED BREAKTHROUGH THERAPY DESIGNATION FOR XALKORI FOR TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY SYSTEMIC ALCL THAT IS ALK-POSITIVE.  Full Article

ACCC Unsuccessful In Appeal Against Pfizer
Friday, 25 May 2018 

May 25 (Reuters) - Australian Competition and Consumer Commission::FULL COURT OF THE FEDERAL COURT OF AUSTRALIA DISMISSED APPEAL BY ACCC AGAINST EARLIER JUDGMENT IN RELATION TO PFIZER AUSTRALIA PTY LTD.  Full Article

FDA Grants Breakthrough Therapy Designation For Pfizer's Tafamidis
Wednesday, 23 May 2018 

May 23 (Reuters) - Pfizer Inc ::FDA GRANTS BREAKTHROUGH THERAPY DESIGNATION FOR TAFAMIDIS FOR THE TREATMENT OF PATIENTS WITH TRANSTHYRETIN CARDIOMYOPATHY.PFIZER INC - DECISION IS SUPPORTED BY TOPLINE RESULTS FROM TAFAMIDIS PHASE 3 TRANSTHYRETIN CARDIOMYOPATHY (ATTR-ACT) STUDY.  Full Article

Trial shows Pfizer's Lyrica reduces seizures in children with epilepsy
Thursday, 17 May 2018 

May 17 (Reuters) - Pfizer Inc ::LYRICA® (PREGABALIN) ORAL SOLUTION CV PHASE 3 TRIAL IN PEDIATRIC EPILEPSY MEETS PRIMARY ENDPOINT.PFIZER - POSITIVE TOP-LINE RESULTS OF PHASE 3 STUDY EXAMINING USE OF LYRICA ORAL SOLUTION CV AS ADJUNCTIVE THERAPY.PFIZER - RESULTS SHOWED ADJUNCTIVE TREATMENT WITH LYRICA 14 MG/KG/DAY RESULTED IN STATISTICALLY SIGNIFICANT REDUCTION IN SEIZURE FREQUENCY VERSUS PLACEBO.PFIZER INC - TREATMENT WITH LYRICA AT LOWER DOSE DID NOT RESULT IN STATISTICALLY SIGNIFICANT REDUCTION IN SEIZURE FREQUENCY VERSUS PLACEBO.  Full Article

Pfizer’S Biosimilar Retacrit® (Epoetin Alfa-Epbx) Approved By U.S. FDA
Tuesday, 15 May 2018 

May 15 (Reuters) - Pfizer Inc ::PFIZER’S BIOSIMILAR RETACRIT® (EPOETIN ALFA-EPBX) APPROVED BY U.S. FDA.PFIZER INC - RETACRIT IS EXPECTED TO BE AVAILABLE IN U.S. AT A SIGNIFICANT DISCOUNT TO CURRENT WHOLESALER ACQUISITION COST OF EPOGEN AND PROCRIT.PFIZER INC - ENTERED AGREEMENT WITH VIFOR PHARMA INC FOR COMMERCIALIZATION OF RETACRIT IN CERTAIN CHANNELS.  Full Article

U.S. FDA Approves Retacrit As Biosimilar To Epogen/Procrit For Treatment Of Anemia
Tuesday, 15 May 2018 

May 15 (Reuters) - The U.S. Food and Drug Administration::SAYS APPROVED RETACRIT AS BIOSIMILAR TO EPOGEN/PROCRIT FOR TREATMENT OF ANEMIA.SAYS GRANTED APPROVAL OF RETACRIT TO HOSPIRA INC, A PFIZER COMPANY.SAYS AS WITH EPOGEN/PROCRIT, RETACRIT CONTAINS BOXED WARNING ABOUT INCREASED RISKS OF DEATH, HEART PROBLEMS, STROKE, TUMOR GROWTH OR RECURRENCE.SAYS APPROVAL OF RETACRIT FOR TREATMENT OF ANEMIA CAUSED BY CHRONIC KIDNEY DISEASE, CHEMOTHERAPY, OR USE OF ZIDOVUDINE IN PATIENTS WITH HIV INFECTION.SAYS RETACRIT HAS BEEN APPROVED AS A BIOSIMILAR, NOT AS AN INTERCHANGEABLE PRODUCT.  Full Article

Xtalpi Says Research Collaboration With Pfizer To Develop Artificial Intelligence-Powered Software Platform
Tuesday, 8 May 2018 

May 8 (Reuters) - Xtalpi Inc::XTALPI INC - STRATEGIC RESEARCH COLLABORATION WITH PFIZER TO DEVELOP A HYBRID PHYSICS- AND ARTIFICIAL INTELLIGENCE-POWERED SOFTWARE PLATFORM.  Full Article

Pfizer Doses First Patient Using Investigational Mini Dystrophin Gene Therapy For The Treatment Of Duchenne Muscular Dystrophy
Thursday, 12 Apr 2018 

April 12 (Reuters) - Pfizer Inc ::PFIZER DOSES FIRST PATIENT USING INVESTIGATIONAL MINI-DYSTROPHIN GENE THERAPY FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY.EARLY DATA FROM MINI-DYSTROPHIN GENE THERAPY STUDY TRIAL ARE EXPECTED IN FIRST HALF OF 2019 .  Full Article

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How U.S. tax reform rewards companies that shift profit to tax havens

The corporate tax cut passed by U.S. President Donald Trump and fellow Republicans that was in part designed to help dissuade U.S. companies from moving profits overseas may instead make the practice a lot more rewarding.