NEW YORK, NY--(Marketwire - Feb 14, 2013) - 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 Alexza Pharmaceuticals, Inc. (NASDAQ: ALXA) and Savient Pharmaceuticals, Inc. (NASDAQ: SVNT).
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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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Alexza Pharmaceuticals' products are based on the Staccato system, a hand-held inhaler that is designed to deliver a drug aerosol to the deep lung, providing rapid systemic delivery and therapeutic onset with ease and convenience for patients. Currently the company has six development programs focused on six acute and intermittent conditions.
Savient's mission is to develop and commercialize pharmaceutical specialty products. On September 14, 2010 the FDA approved KRYSTEXXA. Savient has exclusively licensed worldwide rights to the technology related to KRYSTEXXA and its uses from Duke University and Mountain View Pharmaceuticals, Inc. Last month KRYSTEXXA was granted marketing authorization from the European Commission for the treatment of certain patients with chronic tophaceous gout.
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