NEW YORK, NY -- (Marketwire) -- 02/01/13 -- 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 ISIS Pharmaceuticals, Inc. (NASDAQ: ISIS) and Keryx Biopharmaceuticals (NASDAQ: KERX).
Access to the full company reports can be found at:
www.RDInvesting.com/ISIS
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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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Isis is exploiting its leadership position in antisense technology to discover and develop novel drugs for its product pipeline and for its partners. The company recently reported that the FDA has approved their New Drug Application (NDA) for its cholesterol treatment, Kynamro. The FDA approval triggers a $25 million milestone payment to Isis from its partner Genzyme.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease. Shares of the company have been on an impressive run since reporting their kidney drug, Zerenex, met primary and all key secondary endpoints in a recent Phase 3 study. The company expects to submit a NDA for Zerenex with the FDA in the second quarter of 2013.
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