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Pfizer Inc (PFE.N)

PFE.N on New York Stock Exchange

36.58USD
12 Dec 2017
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Latest Key Developments (Source: Significant Developments)

U.S. FDA Extends Action Date For Expanded Label of Pfizer's Xeljanz In Ulcerative Colitis By Three Months
3:22am IST 

Dec 12 (Reuters) - Pfizer Inc ::U.S. FOOD AND DRUG ADMINISTRATION EXTENDS ACTION DATE FOR XELJANZ® (TOFACITINIB) SUPPLEMENTAL NEW DRUG APPLICATION IN ULCERATIVE COLITIS BY THREE MONTHS.PFIZER INC - FDA HAS PROVIDED AN ANTICIPATED PRESCRIPTION DRUG USER FEE ACT DATE IN JUNE 2018.PFIZER INC - DRUG HAS BOXED WARNING REGARDING PATIENTS TREATED WITH XELJANZ/XELJANZ XR ARE AT INCREASED RISK FOR DEVELOPING SERIOUS INFECTIONS.  Full Article

Teva Announces Exclusive Launch Of Generic Viagra Tablets In The United States
Monday, 11 Dec 2017 

Dec 11 (Reuters) - Teva Pharmaceutical Industries Ltd ::TEVA ANNOUNCES EXCLUSIVE LAUNCH OF GENERIC VIAGRA® TABLETS IN THE UNITED STATES.TEVA PHARMACEUTICAL INDUSTRIES LTD - ‍EXCLUSIVE LAUNCH OF ITS GENERIC VIAGRA TABLETS IN U.S​.  Full Article

Puma Biotechnology Announces Positive Outcome Of European Opposition Proceedings
Monday, 11 Dec 2017 

Dec 11 (Reuters) - Puma Biotechnology Inc ::PUMA BIOTECHNOLOGY ANNOUNCES POSITIVE OUTCOME OF EUROPEAN OPPOSITION PROCEEDINGS.PUMA BIOTECHNOLOGY - EUROPEAN PATENT OFFICE HAS UPHELD CLAIMS IN PUMA'S LICENSED EUROPEAN PATENT, EP 2416774, WHICH WERE BEING OPPOSED BY HEXAL AG.  Full Article

Pfizer Inc Announces Private Exchange Offer For Its 6.500 Per Cent Notes Due 2038
Thursday, 7 Dec 2017 

Dec 7 (Reuters) - Pfizer Inc ::PFIZER INC. ANNOUNCES (I) PRIVATE EXCHANGE OFFER FOR ITS 6.500 PER CENT. NOTES DUE 2038 OPEN TO CERTAIN INVESTORS AND RELATED TENDER OFFER OPEN TO ALL INVESTORS AND (II) TENDER OFFER FOR ITS 5.750 PER CENT. NOTES DUE 2021 AND RELATED SOLICITATION OF CONSE.PFIZER INC - COMMENCED A PRIVATE OFFER TO EXCHANGE ANY AND ALL OF ITS OUTSTANDING GBP 1.5 BILLION 6.500 PER CENT.PFIZER INC- EXCHANGE OFFER WILL EXPIRE AT 5:00 P.M. (NEW YORK TIME) ON DECEMBER 14, 2017.  Full Article

Pfizer Announces Updated Progression-Free Survival Results
Wednesday, 6 Dec 2017 

Dec 6 (Reuters) - Pfizer Inc ::UPDATED DATA FROM PHASE 3 TRIAL OF IBRANCE® (PALBOCICLIB) PLUS LETROZOLE IN ER+, HER2- METASTATIC BREAST CANCER CONFIRM IMPROVEMENT IN PROGRESSION-FREE SURVIVAL.- UPDATED DATA CONSISTENT WITH RESULTS FROM PRIMARY ANALYSIS FOR PALOMA-2.SAYS ‍OVERALL SURVIVAL DATA WERE NOT YET MATURE AT TIME OF THIS UPDATED PFS ANALYSIS​.- UPDATED DATA DEMONSTRATE THAT COMBINATION OF IBRANCE PLUS LETROZOLE REDUCED RISK OF DISEASE PROGRESSION BY 44 PERCENT.  Full Article

Acentrus Specialty Signs New Agreement With Pfizer Oncology
Monday, 4 Dec 2017 

Pfizer Inc ::ACENTRUS SPECIALTY SIGNS NEW AGREEMENT WITH PFIZER ONCOLOGY.ACENTRUS SPECIALTY SAYS SIGNED NEW AGREEMENT THAT OFFERS QUALIFIED ACENTRUS HOSPITAL AND HEALTH SYSTEM CLIENTS ACCESS TO PFIZER ONCOLOGY PRODUCTS.ACENTRUS SPECIALTY - CONTRACT INCLUDES 5 ORAL ONCOLYTIC PRODUCTS; IBRANCE, BOSULIF , SUTENT , INLYTA AND XALKORI​.  Full Article

Basilea Extends Existing License Agreement With Pfizer For Cresemba
Friday, 1 Dec 2017 

Dec 1 (Reuters) - BASILEA PHARMACEUTICA AG ::BASILEA EXTENDS EXISTING LICENSE AGREEMENT WITH PFIZER <<>> FOR ANTIFUNGAL CRESEMBA® (ISAVUCONAZOLE) TO CHINA AND ASIA PACIFIC.BASILEA UPDATES ITS FINANCIAL GUIDANCE FOR 2017 - IMPROVED RESULT EXPECTED.ELIGIBLE TO RECEIVE MILESTONE PAYMENTS OF UP TO USD 226 MILLION AND MID-TEEN ROYALTIES ON SALES.WILL RECEIVE UPFRONT PAYMENT OF USD 3 MILLION.FOR FY EXPECTS A REDUCED OPERATING LOSS OF APPROXIMATELY CHF 1 MILLION ON AVERAGE PER MONTH.FOR FY SEES LOWER OPERATING EXPENSES.  Full Article

Amphastar Announces Approval For Medroxyprogesterone Acetate Injectable Suspension, USP
Thursday, 30 Nov 2017 

Nov 29 (Reuters) - Amphastar Pharmaceuticals Inc ::AMPHASTAR ANNOUNCES APPROVAL FOR MEDROXYPROGESTERONE ACETATE INJECTABLE SUSPENSION, USP.SAYS AMPHASTAR ANTICIPATES LAUNCHING ITS PRODUCT IN Q1 OF 2018.SAYS U.S. FDA GRANTED APPROVAL OF 2 ABBREVIATED NEW DRUG APPLICATIONS FOR MEDROXYPROGESTERONE ACETATE INJECTABLE SUSPENSION.SAYS APPROVAL FOR MEDROXYPROGESTERONE ACETATE INJECTABLE SUSPENSION, USP 150 MG/ML, 1ML VIAL, & 1ML PREFILLED SYRINGE, RESPECTIVELY.  Full Article

Merck And Pfizer Provide Update On Phase III Javelin Gastric 300 Study In Patients With Pre-Treated Advanced Gastric Cancer
Tuesday, 28 Nov 2017 

Nov 28 (Reuters) - Pfizer Inc ::MERCK AND PFIZER PROVIDE UPDATE ON PHASE III JAVELIN GASTRIC 300 STUDY IN PATIENTS WITH PRE-TREATED ADVANCED GASTRIC CANCER.MERCK KGAA- ‍PHASE III JAVELIN GASTRIC 300 TRIAL DID NOT MEET ITS PRIMARY ENDPOINT ​.MERCK KGAA- ‍SAFETY PROFILE OF AVELUMAB WAS CONSISTENT WITH THAT OBSERVED IN OVERALL JAVELIN CLINICAL DEVELOPMENT PROGRAM​.MERCK KGAA - ‍OUTCOME OF JAVELIN GASTRIC 300 DOES NOT HAVE ANY IMPACT ON CURRENT AVELUMAB APPROVALS​.MERCK KGAA - ‍JAVELIN GASTRIC 300 DATA WILL BE FURTHER EXAMINED TO BETTER UNDERSTAND RESULTS; WILL BE SUBMITTED FOR PRESENTATION AT MEDICAL CONGRESS​.  Full Article

U.S. FDA approves Juluca, a two-drug regimen for certain patients with HIV
Wednesday, 22 Nov 2017 

Nov 21 (Reuters) - U.S. Food and Drug Administration::Approved Juluca, a fixed-dose tablet containing dolutegravir and rilpivirine, to treat adults with HIV-1 infections ‍​.Granted approval of Juluca to ViiV Healthcare​.  Full Article

BRIEF-U.S. FDA Extends Action Date For Expanded Label of Pfizer's Xeljanz In Ulcerative Colitis By Three Months

* U.S. FOOD AND DRUG ADMINISTRATION EXTENDS ACTION DATE FOR XELJANZ® (TOFACITINIB) SUPPLEMENTAL NEW DRUG APPLICATION IN ULCERATIVE COLITIS BY THREE MONTHS