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Arena Pharmaceuticals, Inc. Message Board

  • chrisanja chrisanja Mar 21, 2013 4:47 PM Flag

    EMA approved 84% of drugs in 2012

    While we wait... googled "EMA Approval"

    Interesting that EMA approves 84% of drugs. No expert here, but it seems to me they knock down and knock out companies and drugs that are going to be rejected; many bow out before a decision.

    Many times have we seen the "93%" when a LoOI is issued. Just thought I'd pass this along. AF seemed very sure of Belviq rejection. I'd say the odds are in our favor. One of the 16% was Qsymia. LOL

    San Diego, Feb. 11, 2013 (GLOBE NEWSWIRE) -- Sagient Research Systems, a leading publisher of independent research for the financial services, institutional investment and corporate intelligence communities, recently published an updated report analyzing approval rates at the U.S Food and Drug Administration (FDA) and European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). According to its research service, BioMedTracker, the rate of drugs that were approved by the FDA in fiscal year 2011 and 2012 were 69% and 76%, respectively. The 76% marked a significant increase over the 5 year average of 69%. The report also analyzed EMA approval rates, with 2011 marking a 6-year high of 84% of drugs receiving a positive opinion. In addition, the report analyzed the regulatory timelines of both agencies, providing in-depth analysis by disease group for each agency, as well as stock price movements around PDUFA and EMA decision dates. The report also highlighted important upcoming PDUFA decisions for Aveo's (NASDAQ: AVEO), Tivopath for Renal Cell Cancer, GlaxoSmithKline's (NYSE:GSK) Breo Ellipta for Chronic Obstructive Pulmonary Disease and Biogen Idec's (NASDAQ: BIIB) Tecfidera for Multiple Sclerosis.

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