Source: Sagient Research Systems

Sagient Research Publishes Report on FDA and EMA Approval Rates

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.

BioMedTracker is an independent research service that offers proprietary clinical assessments and patient-based revenue forecasts of developmental drugs within a comprehensive and intuitive drug information database. Clients from the pharmaceutical, biotech, and investment industries rely on BioMedTracker for its insight on the likelihood of approval, commercial potential, and future data and regulatory catalysts for drugs within the competitive landscape of every important disease and indication.  CatalystTracker is the most efficient method to track upcoming volatility events for public companies.  Catalysts are constantly updated by Sagient's in-house analyst team and presented to clients online in an easy to use, searchable, and customizable format.

Commenting on the report of FDA Approval Rates, William Akie, Senior Research Analyst for BioMedTracker said, "Companies looking to file for approvals in the US and EU will be happy to see recent up-ticks in regulatory approvals and approval rates in both regions. Additionally, though Europe has often been seen as a lagging regulatory agency, it appears that much of the delay to market is due to companies filing later in Europe than the US, and the time between CHMP opinion (Approval decision) and EMA ratification." Akie continued, "Drugs approved in recent years had fairly similar regulatory timelines in both the US, and EU, with the EU approving drugs at a higher rate."

                                                            BioMedTracker FDA Approval Rates: 2008 - 2012
  Decision Type 2012 2011 2010 2009
  Approved 76% 69% 64% 68%
  Not-Approved 24%  31% 36% 32%

BioMedTracker's powerful biomedical investment information can be accessed online with a paid subscription via

CatalystTracker's dynamic updating upcoming catalyst calendar can be accessed online with a paid subscription via

Sagient's product portfolio also includes PlacemenTracker, a dynamic, customizable research service that provides clients with market data, research, and analysis on the PIPE (Private Investment in Public Entity) market.  This data can be accessed online with a paid subscription via

To arrange for a demonstration of  BioMedTracker and CatalystTracker, or to obtain a copy of FDA Report Update, please send an inquiry to:     


About Sagient Research Systems

Sagient Research Systems is a publisher of specialized research and data. We develop, produce, and sell proprietary research products to global enterprises, including investment banks, mutual and hedge funds, pharmaceutical companies, academic institutions, and government agencies. Our business strategy is to continue to leverage our development, technology, and marketing expertise to solidify our position as a leading provider of independent research.

In each of 2007, 2008, 2009, 2010 and 2012 Sagient Research was recognized by Inc. Magazine as one of the 5000 fastest-growing private companies in America. For more information, please visit the Sagient Research Systems website at

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