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Pfizer Inc (PFE.N)

PFE.N on New York Stock Exchange

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15 Nov 2018
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Latest Key Developments (Source: Significant Developments)

Pfizer Says U.S. FDA Approves Lorbrena
Friday, 2 Nov 2018 

Nov 2 (Reuters) - Pfizer Inc ::U.S. FDA APPROVES LORBRENA® (LORLATINIB) FOR PREVIOUSLY-TREATED ALK-POSITIVE METASTATIC NSCLC.PFIZER INC - APPROVAL WAS BASED ON A NON-RANDOMIZED, DOSE-RANGING AND ACTIVITY-ESTIMATING, MULTI-COHORT, MULTICENTER PHASE 1/2 STUDY, B7461001.  Full Article

FDA Says Some Epipen Auto-Injectors May Not Readily Slide Out Of Carrier Tube
Friday, 2 Nov 2018 

Nov 2 (Reuters) - U.S. FOOD AND DRUG ADMINISTRATION::FDA SAYS IN A VERY SMALL NUMBER OF CASES, SOME EPIPEN AUTO-INJECTORS MAY NOT READILY SLIDE OUT OF CARRIER TUBE - TWEET.  Full Article

Pfizer CEO Hopes Trump Administration Reconsiders Plan To Base Medicare Part B Drug Prices On Cheaper Prices Paid Outside U.S.
Tuesday, 30 Oct 2018 

Oct 30 (Reuters) - Pfizer Inc ::PFIZER CEO SAYS "WE ARE SUPPORTIVE OF DEVELOPING A MARKET-BASED ALTERNATIVE TO THE CURRENT BUY-AND-BILL SYSTEM... A SYSTEM FACILITATED BY MANY VENDORS, NOT JUST ONE OR TWO PBM'S" - CONF. CALL."WE ARE TAKING STEPS TO SIMPLIFY THE ORGANIZATION. WE EXPECT TO NOT ONLY GENERATE SAVINGS BUT TO REDUCE BUREAUCRACY AND EXPEDITE DECISION-MAKING" - INCOMING CEO ALBERT BOURLA - CONF. CALL."WE CONTINUE NOT TO SEE THE NEED FOR ANY LARGE SCALE M&A ACTIVITY AT THIS TIME" - PFIZER INCOMING CEO ALBERT BOURLA.PFIZER EXPECTS TO MAKE A DECISION BY YEAR-END ON CONSUMER HEALTH BUSINESS- INCOMING CEO ALBERT BOURLA.PFIZER CEO HOPES TRUMP ADMINISTRATION RECONSIDERS PLAN TO BASE MEDICARE PART B DRUG PRICES ON CHEAPER PRICES PAID OUTSIDE U.S. - CONF. CALL.PFIZER SAYS EXPECTS SUPPLY FROM STERILE INJECTABLES UNIT TO IMPROVE SIGNIFICANTLY TOWARDS END OF 2019 - CONF. CALL.A LARGE M&A TYPICALLY COMES WITH BIG INTEGRATION PLANS AND DISTRACTS OPERATIONS AND THIS IS WHAT WE'D LIKE TO AVOID -CEO DESIGNATE ALBERT BOURLA - CONF. CALL.PFIZER EXPECTS TO TAKE PRICE INCREASE DECISIONS IN JANUARY- CONF. CALL.  Full Article

Pfizer Inc announces complete results from Phase 3 Study evaluating efficacy, safety of subcutaneous administration of Tanezumab
Tuesday, 23 Oct 2018 

Oct 23 (Reuters) - Pfizer Inc ::PFIZER INC - ANNOUNCES COMPLETE RESULTS FROM PHASE 3 STUDY EVALUATING EFFICACY, SAFETY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB.PFIZER INC - PHASE 3 STUDY MET ALL THREE CO-PRIMARY EFFICACY ENDPOINTS.PFIZER INC - TANEZUMAB WAS GENERALLY WELL TOLERATED IN PHASE 3 STUDY.PFIZER INC - OVER HALF OF PATIENTS TREATED WITH TANEZUMAB REPORTED 50 PERCENT OR GREATER REDUCTION IN OSTEOARTHRITIS PAIN OF KNEE/HIP.PFIZER INC - THERE WERE NO CASES OF OSTEONECROSIS OBSERVED IN PHASE 3 STUDY.PFIZER INC - ADDITIONAL READOUTS FROM PHASE 3 PROGRAM ARE ANTICIPATED BEGINNING IN H1 2019.PFIZER INC - IN PHASE 3 STUDY, NASOPHARYNGITIS, PAIN INEXTREMITY AND PARESTHESIA WERE THE MOST COMMON ADVERSE EVENTS.  Full Article

Biomarin Receives Milestone Payments From Pfizer For Talzenna
Tuesday, 16 Oct 2018 

Oct 16 (Reuters) - Biomarin Pharmaceutical Inc ::BIOMARIN RECEIVES MILESTONE PAYMENTS FROM PFIZER FOR TALZENNA® (TALAZOPARIB) FOR METASTATIC BREAST CANCER PATIENTS WITH AN INHERITED BRCA MUTATION.BIOMARIN PHARMACEUTICAL INC - FDA APPROVAL TRIGGERS $15 MILLION PAYMENT.BIOMARIN PHARMACEUTICAL - ENTITLED TO EARN MID-SINGLE DIGIT ROYALTIES ON FUTURE SALES.  Full Article

Pfizer Inc Says Board Approved New Compensation Arrangements For Albert Bourla
Monday, 1 Oct 2018 

Oct 1 (Reuters) - Pfizer Inc ::PFIZER INC - BOARD APPROVED NEW COMPENSATION ARRANGEMENTS FOR ALBERT BOURLA INCLUDING INCREASE IN HIS ANNUAL BASE SALARY FROM $1.4 MILLION TO $1.6 MILLION.PFIZER INC - BOARD APPROVED NEW COMPENSATION FOR IAN READ IN HIS ROLE AS EXECUTIVE CHAIRMAN AN ANNUAL BASE SALARY OF $1.2 MILLION.PFIZER INC - NEW COMPENSATIONS FOR BOURLA & READ ARE EFFECTIVE FROM JANUARY 1, 2019 WHEN THEY GET INTO THEIR NEW ROLES.  Full Article

Pfizer Granted FDA Breakthrough Therapy Designation For 20-Valent Pneumococcal Conjugate Vaccine
Thursday, 20 Sep 2018 

Sept 20 (Reuters) - Pfizer Inc ::PFIZER GRANTED FDA BREAKTHROUGH THERAPY DESIGNATION FOR 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE FOR THE PREVENTION OF INVASIVE DISEASE AND PNEUMONIA IN ADULTS AGED 18 YEARS AND OLDER.PFIZER INC - PFIZER EXPECTS TO START PHASE 3 TRIALS IN A FEW MONTHS.PFIZER INC - 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE (20VPNC) CANDIDATE, PF-06482077, RECEIVED BREAKTHROUGH THERAPY DESIGNATION FROM US FDA.  Full Article

Pfizer Receives Breakthrough Therapy Designation From FDA For Pf-06651600, An Oral Jak3 Inhibitor, For The Treatment Of Patients With Alopecia Areata
Wednesday, 5 Sep 2018 

Sept 5 (Reuters) - Pfizer Inc ::PFIZER RECEIVES BREAKTHROUGH THERAPY DESIGNATION FROM FDA FOR PF-06651600, AN ORAL JAK3 INHIBITOR, FOR THE TREATMENT OF PATIENTS WITH ALOPECIA AREATA.PFIZER INC - PHASE II DATA ACCEPTED FOR LATE-BREAKER NEWS SESSION AT 2018 EADV CONGRESS.PFIZER INC - PFIZER IS ALSO WORKING WITH EUROPEAN MEDICINES AGENCY (EMA) ON CLINICAL DEVELOPMENT PROGRAM FOR PF-06651600.  Full Article

Pfizer And Astellas Amend Clinical Research Protocols For Two Phase 3 Trials Of Enzalutamide
Wednesday, 22 Aug 2018 

Aug 22 (Reuters) - Astellas Pharma Inc <4503.T>::PFIZER AND ASTELLAS AMEND CLINICAL RESEARCH PROTOCOLS FOR TWO PHASE 3 TRIALS OF ENZALUTAMIDE IN PATIENTS WITH HORMONE-SENSITIVE PROSTATE CANCER.PFIZER INC - AMENDMENTS ACCELERATE ANTICIPATED PRIMARY COMPLETION DATES FOR BOTH ARCHES AND EMBARK TRIALS.PFIZER INC - AMENDMENTS TO PROTOCOLS FOR TWO REGISTRATIONAL PHASE 3 TRIALS, ARCHES AND EMBARK.PFIZER INC - CHANGES TO PROTOCOL FOR PHASE 3 ARCHES STUDY INCLUDE REVISION OF PLANNED ANALYSES OF PRIMARY AND SECONDARY ENDPOINTS.PFIZER INC - COS ANTICIPATE PRIMARY COMPLETION DATE FOR ARCHES CLINICAL TRIAL TO BE IN LATE 2018.PFIZER INC - ESTIMATED PRIMARY COMPLETION DATE FOR EMBARK CLINICAL TRIAL IS MID-2020.PFIZER INC - REVISIONS WERE ALSO MADE TO PROTOCOL FOR PHASE 3 EMBARK STUDY.PFIZER - MAIN PURPOSE OF AMENDMENT TO PROTOCOL FOR PHASE 3 EMBARK STUDY IS TO REVISE THE PLANNED ANALYSES OF THE PRIMARY & SEVERAL SECONDARY ENDPOINTS.  Full Article

Exact Sciences Says Enter Agreement Through 2021 With Pfizer To Co-Promote Cologuard
Wednesday, 22 Aug 2018 

Aug 22 (Reuters) - Exact Sciences Corp ::EXACT SCIENCES SAYS CO, PFIZER ENTER INTO AGREEMENT THROUGH 2021 TO CO-PROMOTE COLOGUARD, A STOOL DNA SCREENING TEST FOR COLORECTAL CANCER.EXACT SCIENCES SAYS AS PER AGREEMENT, PFIZER WILL CO-PROMOTE COLOGUARD WITH CO BEGINNING IN Q4 2018.EXACT SCIENCES SAYS AS PER AGREEMENT, CO WILL MAINTAIN RESPONSIBILITY FOR ALL ASPECTS OF MANUFACTURING & LABORATORY OPERATIONS OF COLOGUARD.EXACT SCIENCES SAYS AS PER AGREEMENT, PFIZER WILL SHARE GROSS PROFITS & MARKETING EXPENSES EQUALLY ABOVE AN AGREED UPON BASELINE.  Full Article

Novartis launches third-to-market Remicade copy in Germany

ZURICH, Nov 15 Novartis launched a copy of Johnson & Johnson's (J&J) inflammation-fighting Remicade in Germany on Thursday as the Swiss drugmaker aims to catch rival biosimilars that are already available in Europe's largest healthcare market.