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 Celldex Therapeutics, Inc. (NASDAQ: CLDX) and Peregrine Pharmaceuticals (NASDAQ: PPHM).
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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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Celldex's deep product pipeline consists of products in varying stages of development, with lead candidates CDX-110 preparing to enter a Phase 3 clinical trial in newly diagnosed glioblastoma multiforme, one of the most aggressive forms of brain cancer, and CDX-011 currently undergoing evaluation in a Phase 2b clinical trial in advanced breast cancer.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials focused on the treatment and diagnosis of cancer. Shares of the company fell sharply Wednesday after reporting Bavituximab showed "modest" results in a recent Phase II clinical trial for the treatment of Stage IV pancreatic cancer.
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