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Vimizim: Regulatory applications on track. FDA Advisory Committee Meeting expected to be scheduled for November 19, 2013.
BMN 701: Maximal Inspiratory Pressure (MIP) accepted by FDA as primary endpoint for Phase 3 Study in Late Onset Pompe Disease.
BMN 111: US and European Regulatory Authorities agree that Phase 2 Study in Achondroplasia can start without additional data.
BMN 190: BioMarin enrolls first patient in Phase 1/2 Study for the treatment of Neuronal Ceroid Lipofuscinosis Type 2, a form of Batten Disease.
SAN RAFAEL, Calif., Sept. 17, 2013 (GLOBE NEWSWIRE) -- BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced highlights to be presented at the company's Research and Development Day for the investment community to be held today from 8:00 a.m. to 12:00 p.m. ET. Members of BioMarin's management team and industry experts will provide an update on the company's product portfolio and advancements in the research and development pipeline. Interested parties may access a live audio webcast and slides of the presentation via the investor section of the BioMarin website,
Vimizim for the Treatment of Morquio A
BioMarin announced today that it expects that Vimizim will be reviewed by the U.S. Food and Drug Administration Advisory Committee on November 19, 2013. The Company noted that the FDA has previously granted Vimizim priority review designation and assigned a PDUFA date of February 28, 2014. The European Medicines Agency (EMA) has validated the Vimizim Marketing Authorization Application (MAA) and has granted accelerated review status, which could lead to a (Committee for Medicinal Products for Human Use) CHMP opinion before year end. During the second quarter of 2013, the company also submitted the Marketing Authorisation (MA) in Brazil. Ongoing production of bulk drug substance and drug product will allow for a global launch of Vimizim following approvals in multiple countries. Both the FDA and EMA have conducted or scheduled pre-approval inspections associated with the review of the marketing applications.