|By Marketwired .||
|February 6, 2013 08:20 AM EST||
NEW YORK, NY -- (Marketwire) -- 02/06/13 -- 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 Geron Corporation (NASDAQ: GERN) and MannKind Corporation (NASDAQ: MNKD).
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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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Geron is a biopharmaceutical company developing first-in-class therapies for cancer, including its telomerase inhibitor, imetelstat. Imetelstat (GRN163L) is a potent and specific inhibitor of telomerase currently in clinical development as a potential therapeutic agent for the treatment of solid tumor and hematological malignancies.
MannKind's lead investigational product candidate, AFREZZA is a novel, ultra rapid-acting mealtime insulin therapy. AFREZZA is in late stage clinical investigation for the treatment of adults with type 1 or type 2 diabetes for the control of hyperglycemia. The company is scheduled to release it fourth quarter and full year results on Monday, February 11th.
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