ACAD Phase 3 data expected 4Q. SUPN PDUFA date confirmed. THRX file NDA and MAA for COPD

Jul 15, 2012 No Comments by

ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) said in a SEC filing that it expects to complete enrolment in its Phase 3 efficacy, tolerability and safety trial with pimavanserin for Parkinson’s disease psychosis, during August 2012. Data is expected later in 4Q 2012.

Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN) confirmed the PDUFA date for SPN-804 (extended-release oxcarbazepine) for epilepsy, is October 19, 2012. It also mentioned that its product Trokendi (formerly known as SPN-538) which had been given tentative approval from the FDA, will not be given final approval until the period of exclusivity protection associated with paediatric patients, age 1-24 months, expires on June 22, 2013. As a result the company now expects to launch Trokendi in 3Q 2013.

GlaxoSmithKline plc (GSK) and Theravance, Inc. (Nasdaq:THRX) today announced the submission of NDA and MAA filings in the US and European Union for the once-daily investigational medicine fluticasone furoate “FF”/vilanterol “VI” (FF/VI) for patients with chronic obstructive pulmonary disease (COPD) and a MAA filing for asthma in the European Union. For asthma, GSK and Theravance are reviewing the strategy for a future US filing.

Daily News

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Currently residing in New Zealand, Mr. A.Burden holds a Master of Commerce in International Business from the University of Sydney and used these skills together with his passion for investing to establish BioPharmCatalyst in June 2010 as a tool for investing decisions in the US pharmaceutical market. He spends much of his free time mountain biking, playing squash and hiking.
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