U.S. Food and Drug Administration Approved 30% More Drugs in 2012
RDInvesting Provides Stocks Research on Sangamo Biosciences and Spectrum Pharmaceuticals
NEW YORK, NY -- (Marketwire) -- 02/28/13 -- 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 Sangamo Biosciences, Inc. (NASDAQ: SGMO) and Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI).
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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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Sangamo is a clinical stage biopharmaceutical company focused on the research, development and commercialization of engineered DNA-binding proteins for the development of novel therapeutic strategies for unmet medical needs. The company is using engineered zinc finger DNA-binding protein transcription factors (ZFP TFs) to "up-regulate" or "down-regulate" gene expression to achieve a desired therapeutic effect.
Spectrum has three marketed oncology products and two products in late-stage development. The company also has as a diversified portfolio of proprietary drugs in various stages of development, with a focus on oncology/hematology. The company reported a net income of $94.5 million for the full year 2012, nearly double the net income of $48.5 million posted in 2011.
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