Sharp Increase in FDA Drug Approvals a Major Factor in Biotech Industry's Success
Research Driven Investing Provides Stocks Research on ImmunoGen and Omeros
NEW YORK, NY -- (Marketwire) -- 02/12/13 -- 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 ImmunoGen, Inc. (NASDAQ: IMGN) and Omeros Corporation (NASDAQ: OMER).
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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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ImmunoGen develops targeted anticancer therapeutics using our expertise in cancer biology, engineered antibodies and highly potent cancer-cell killing agents. Ten TAP compounds are now in clinical testing, of which three are wholly owned by the company. Marketing applications for T-DM1, the most advanced compound using ImmunoGen's TAP technology, are under review in the US and Europe.
Omeros is committed to discovering, developing and commercializing products targeting inflammation, coagulopathies and disorders of the central nervous system. The company's most clinically advanced product candidates, OMS302 for lens replacement surgery and OMS103HP for arthroscopy, are derived from its proprietary PharmacoSurgery platform designed to improve clinical outcomes of patients undergoing a wide range of surgical and medical procedures.
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