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BRIEF-FDA not planning to hold advisory committee meeting for Biomarin's Pegvaliase BLA
September 14, 2017 / 8:26 PM / 3 months ago

BRIEF-FDA not planning to hold advisory committee meeting for Biomarin's Pegvaliase BLA

Sept 14 (Reuters) - Biomarin Pharmaceutical Inc

* FDA not currently planning to hold advisory committee meeting for Biomarin’s Pegvaliase Biologics License Application (BLA)

* Biomarin Pharmaceutical Inc - ‍FDA has provided company with “Day-74” filing communication for its BLA for Pegvaliase​

* Biomarin Pharmaceutical Inc - ‍FDA comments based on preliminary evaluation are generally in-line with company’s expectations​

* Biomarin Pharmaceutical Inc- PDUFA action date is February 28, 2018

* Biomarin Pharmaceutical-FDA indicated that review is proceeding according to agency’s internal review timelines ​

* Biomarin- ‍FDA requested additional chemistry, manufacturing, controls information, which we expect, will result in 3 month extension of PDUFA date​ Source text for Eikon: Further company coverage:

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