NEW YORK, NY--(Marketwire - Feb 1, 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 Biotechnology Industry and provides equity research on Aegerion Pharmaceuticals, Inc. (
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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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Aegerion Pharmaceuticals is a biopharmaceutical company dedicated to the development and commercialization of innovative, life-altering therapies for patients with debilitating, often fatal, rare diseases. JUXTAPID was approved by the U.S. Food and Drug Administration in December 2012 as an adjunct to a low-fat diet and other lipid-lowering treatments.
Vertex focuses on discovering and developing new medicines for some of the world's most devastating diseases. Earlier this month, the company reported that the first two Breakthrough Therapy Designations from U.S. FDA has been granted to Kalydeco (ivacaftor) monotherapy and to the combination regimen of VX-809 with ivacaftor for the treatment of cystic fibrosis.
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