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RSS FeedsPortola Pharmaceuticals Provides Update on European Marketing Authorization Application for Betrixaban
(WorldNews Health)

 
 

12 december 2017 15:36:16

 
Portola Pharmaceuticals Provides Update on European Marketing Authorization Application for Betrixaban
(WorldNews Health)
 


South San Francisco, Calif., Dec. 12, 2017 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc. (Nasdaq:PTLA) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has requested additional information related to the Marketing Authorization Application (MAA) for betrixaban. The CHMP has provided the Day 195 List of Outstanding Issues (LoOI) to the company with a request for responses during the next available submission window of January 23, 2018. Based on this new timeline, the Company expects the CHMP to issue an opinion later in the first quarter of 2018. `We have had a productive ongoing dialogue with the CHMP throughout the MAA...


 
10 viewsCategory: Science > Medicine
 
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