NEW YORK, NY -- (Marketwire) -- 03/04/13 -- 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 Coronado Biosciences Inc. (NASDAQ: CNDO) and Clovis Oncology Inc. (NASDAQ: CLVS).
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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Coronado is a biopharmaceutical company focused on novel immunotherapy biologic agents for autoimmune diseases and cancer. Coronado's two principal pharmaceutical product candidates are initially targeted for clinical development for inflammatory bowel disease, multiple sclerosis and acute myeloid leukemia.
Clovis Oncology has global rights for three product candidates in various stages of development: CO-1686, which is in Phase I/II development for the treatment of non-small cell lung cancer; and rucaparib (CO-338), which is in Phase I/II clinical trials for the treatment of certain ovarian and breast cancers. For their third product candidate, the company is in the discovery phase for a compound to treat patients with gastrointestinal stromal tumors, or GIST, whose cancer is resistant to current therapies.
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