U.S. Food and Drug Administration Approved 30% More Drugs in 2012 Than the Year Previous
http://media.marketwire.com/attachments/201301/56000_Clipboard01.jpghttp://at.marketwire.com/accesstracking/AccessTrackingLogServlet?PrId=981388&ProfileId=051205&sourceType=1NEW YORK, NY -- (Marketwire) -- 02/04/13 -- A sharp increase in drug approvals and mergers and acquisitions combined to create a bull market for the Biotechnology Industry in 2012. The iShares NASDAQ Biotechnology Index (IBB), the SPDR S&P Biotech ETF (XBI) and the First Trust Amex Biotechnology Index ETF (FBT) have all gained over 20 percent in the past year, outperforming the broader markets by a good margin. Research Driven Investing examines investing opportunities in the Biotech Industry and provides equity research on Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN) and Galena Biopharma Inc. (NASDAQ: GALE).
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Bloomberg recently reported drug approvals by the U.S. Food and Drug Administration reached a 15 year high in 2012. The FDA approved a total of 39 novel medicines last year, an increase of 30 percent when compared to a year ago. Oncology drugs lead the way with 11 new drugs approved last year. Over the last ten years the number of FDA approvals had averaged roughly 23 a year. The passage of the Prescription Drug User Fee Act (PDUFA) played a major role in the sharp increase in approvals.
The PDUFA "has provided critical resources for improving the quality and timeliness of premarket review of drugs," said FDA spokeswoman, Sandy Walsh. "These accomplishments could not have been achieved without the innovations of the biopharmaceutical industry and the dedication and skill of FDA's drug review staff."
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Achillion is focused on solutions for the most challenging problems in infectious disease including the hepatitis C virus (HCV). Achillion also has a portfolio of antibacterial drug candidates for the treatment of serious, resistant bacterial infections. Each of these programs was discovered through Achillion's own proprietary internal drug discovery efforts.
Galena Biopharma is focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using targeted biotherapeutics. Based on a successful Phase 2 trial, which achieved its primary endpoint of disease-free survival (DFS), the FDA granted NeuVax a Special Protocol Assessment for its Phase 3 PRESENT study.
Research Driven Investing has not been compensated by any of the above-mentioned publicly traded companies. Paragon Report is compensated by other third party organizations for advertising services. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at:
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