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Portola Pharmaceuticals Inc (PTLA.OQ)

PTLA.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

Portola Pharmaceuticals Submits Prior Approval Supplement To FDA
Friday, 31 Aug 2018 

Aug 31 (Reuters) - Portola Pharmaceuticals Inc ::PORTOLA PHARMACEUTICALS SUBMITS PRIOR APPROVAL SUPPLEMENT TO U.S. FDA FOR LARGE-SCALE GENERATION 2 ANDEXXA PROCESS.PORTOLA PHARMACEUTICALS INC - BASED ON FDA TIMELINES, COMPANY EXPECTS A FINAL DECISION ON PAS IN Q1 2019.PORTOLA PHARMACEUTICALS INC - FINAL CHMP OPINION IS EXPECTED IN Q4 2018 WITH POTENTIAL FOR APPROVAL IN Q1 2019.  Full Article

European CHMP Maintains Negative Opinion On Portola Pharma's Betrixaban Following Appeal
Friday, 27 Jul 2018 

July 27 (Reuters) - Portola Pharmaceuticals Inc ::EUROPEAN CHMP MAINTAINS NEGATIVE OPINION ON PORTOLA PHARMACEUTICALS’ BETRIXABAN FOLLOWING APPEAL.PORTOLA PHARMACEUTICALS - CHMP MAINTAINED ITS NEGATIVE OPINION FOLLOWING A RE-EXAMINATION PROCEDURE REQUESTED BY COMPANY.PORTOLA - WILL CONTINUE WORKING WITH REGULATORY AUTHORITIES IN COUNTRIES OUTSIDE EU TO POTENTIALLY BRING TREATMENT OPTION TO PATIENTS SOON.PORTOLA PHARMACEUTICALS INC - WILL MAINTAIN FOCUS ON U.S. COMMERCIAL LAUNCH OF TREATMENT.PORTOLA PHARMACEUTICALS - IN MAINTAINING NEGATIVE OPINION, CHMP DID NOT CONSIDER OVERALL BETRIXABAN'S RISK-BENEFIT PROFILE SUFFICIENTLY ROBUST.  Full Article

Portola Pharmaceuticals Announces Retirement Of CEO Bill Lis In 2018
Monday, 4 Jun 2018 

June 4 (Reuters) - Portola Pharmaceuticals Inc ::PORTOLA PHARMACEUTICALS ANNOUNCES RETIREMENT OF CEO BILL LIS IN 2018.PORTOLA PHARMACEUTICALS INC - LIS WILL CONTINUE TO SERVE AS CEO AND MEMBER OF BOARD THROUGH AUGUST 1, 2018.PORTOLA PHARMACEUTICALS INC - BOARD HAS INITIATED AN ACTIVE SEARCH TO EVALUATE CANDIDATES TO SERVE AS COMPANY'S NEXT CEO.  Full Article

Portola Pharmaceuticals Announces New Interim Results From Ongoing Annexa-4 Study
Monday, 12 Mar 2018 

March 12 (Reuters) - Portola Pharmaceuticals Inc ::PORTOLA PHARMACEUTICALS ANNOUNCES NEW INTERIM RESULTS FROM ONGOING ANNEXA-4 STUDY OF FACTOR XA INHIBITOR REVERSAL AGENT ANDEXXA® (ANDEXANET ALFA) IN PATIENTS WITH LIFE-THREATENING BLEEDING.PORTOLA PHARMACEUTICALS INC - THE INTERIM RESULTS INCLUDED SAFETY DATA FROM 227 OF 228 ENROLLED PATIENTS.PORTOLA PHARMACEUTICALS INC - EXCELLENT OR GOOD HEMOSTASIS ACHIEVED IN 83 PERCENT OF PATIENTS IN ANNEXA-4.PORTOLA PHARMACEUTICALS INC - ANDEXANET ALFA IS CURRENTLY UNDER REVIEW BY U.S. FDA WITH AN ASSIGNED ACTION DATE OF MAY 4, 2018.  Full Article

Portola Pharma Says FDA will extend review of AndexXa by 90 days
Friday, 22 Dec 2017 

Dec 22 (Reuters) - Portola Pharmaceuticals Inc ::PORTOLA PHARMACEUTICALS PROVIDES UPDATE ON BIOLOGICS LICENSE APPLICATION (BLA) FOR ANDEXXA® (ANDEXANET ALFA).PORTOLA PHARMACEUTICALS - U.S. FDA WILL EXTEND REVIEW OF BIOLOGICS LICENSE APPLICATION FOR ANDEXXA (ANDEXANET ALFA) BY 90 DAYS.  Full Article

U.S. FDA Approves Prior Approval Supplement For Launch Of Portola Pharmaceuticals' Betrixaban
Tuesday, 19 Dec 2017 

Dec 19 (Reuters) - Portola Pharmaceuticals Inc ::U.S. FOOD AND DRUG ADMINISTRATION APPROVES PRIOR APPROVAL SUPPLEMENT FOR COMMERCIAL LAUNCH OF PORTOLA PHARMACEUTICALS’ NOVEL ORAL ANTICOAGULANT BEVYXXA® (BETRIXABAN).PORTOLA PHARMACEUTICALS INC - CO PLANS TO INITIATE COMMERCIAL LAUNCH IN EARLY JANUARY 2018.  Full Article

Portola Provides Update On European Marketing Authorization Application For Betrixaban
Tuesday, 12 Dec 2017 

Dec 12 (Reuters) - Portola Pharmaceuticals Inc ::PORTOLA PHARMACEUTICALS PROVIDES UPDATE ON EUROPEAN MARKETING AUTHORIZATION APPLICATION FOR BETRIXABAN.CHMP OF EMA HAS REQUESTED ADDITIONAL INFORMATION RELATED TO MARKETING AUTHORIZATION APPLICATION (MAA) FOR BETRIXABAN.CHMP OF EUROPEAN MEDICINES AGENCY REQUESTED MORE INFORMATION RELATED TO MARKETING AUTHORIZATION APPLICATION (MAA) FOR BETRIXABAN.PORTOLA PHARMA SAYS CHMP HAS PROVIDED DAY 195 LOOI TO CO WITH REQUEST FOR RESPONSES DURING NEXT AVAILABLE SUBMISSION WINDOW OF JAN 23, 2018.EXPECTS CHMP TO ISSUE AN OPINION ON BETRIXABAN LATER IN Q1 OF 2018..  Full Article

Portola Pharmaceuticals provides update on Bevyxxa commercial launch
Tuesday, 21 Nov 2017 

Nov 21 (Reuters) - Portola Pharmaceuticals Inc ::Portola Pharmaceuticals provides update on Bevyxxa(betrixaban) commercial launch.FDA extended review period for co's prior approval supplement for Bevyxxa to allow agency time to review entire submission​.‍FDA said it will respond to PAS request to change current manufacturing release specification within 60-day extension period​.New action date for Bevyxxa is January 30, 2018​.  Full Article

Portola Pharmaceuticals submits NDA to U.S. FDA for betrixaban
Tuesday, 25 Oct 2016 

Portola Pharmaceuticals Inc : Submits new drug application to U.S. FDA for betrixaban for extended duration prophylaxis of venous thromboembolism in acute medically ill patients . Sees submission of betrixaban NDA as a first step towards a potential approval in 2017 .Says plans to submit a marketing authorization application for approval of betrixaban in EU by end of this year.  Full Article

BRIEF-Portola Pharmaceuticals Receives $100 Mln Milestone Payment From Healthcare Royalty Partners For FDA Approval Of Andexxa

* PORTOLA PHARMACEUTICALS RECEIVES $100 MILLION MILESTONE PAYMENT FROM HEALTHCARE ROYALTY PARTNERS FOR FDA APPROVAL OF ANDEXXA® Source text for Eikon: Further company coverage: