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Portola Pharmaceuticals Inc (PTLA.OQ)

PTLA.OQ on NASDAQ Stock Exchange Global Select Market

47.69USD
16 Feb 2018
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Latest Key Developments (Source: Significant Developments)

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 Complete Response Letter from FDA for biologics license application for AndexXa
Thursday, 18 Aug 2016 

Corrects headline of brief.Portola Pharmaceuticals Inc : Portola pharmaceuticals receives complete response letter from fda for biologics license application for andexxa(tm) (andexanet alfa) . FDA also asked for additional data to support inclusion of edoxaban and enoxaparin in label .In letter, fda requested that portola provide additional information primarily related to manufacturing.  Full Article

Portola Pharmaceuticals reports Q2 loss per share $1.02
Tuesday, 9 Aug 2016 

Portola Pharmaceuticals Inc : Portola Pharmaceuticals reports second quarter 2016 financial results and provides corporate update . Q2 earnings per share view $-1.20 -- Thomson Reuters I/B/E/S .Q2 loss per share $1.02.  Full Article

Portola Pharmaceuticals, inc announces topline results from Phase 3 APEX Trial of Betrixaban for Prevention of Blood Clots in Acute Medically Ill Patients
Thursday, 24 Mar 2016 

Portola Pharmaceuticals, Inc:Says topline data from the Phase 3 APEX (Acute Medically Ill VTE Prevention with Extended Duration Betrixaban) Study.Says there was no statistical difference in major bleeding between the betrixaban and enoxaparin arms in any of these three patient groups.Net clinical benefit with betrixaban was observed.APEX results will be presented at the International Society on Thrombosis and Haemostasis (ISTH) Congress on May 27, 2016.  Full Article

BRIEF-Portola Pharma Says FDA will extend review of AndexXa by 90 days

* PORTOLA PHARMACEUTICALS PROVIDES UPDATE ON BIOLOGICS LICENSE APPLICATION (BLA) FOR ANDEXXA® (ANDEXANET ALFA)