U.S. Food and Drug Administration Approved 30% More Drugs in 2012
Research Driven Investing Provides Stocks Research on Athersys and Rexahn Pharmaceuticals
NEW YORK, NY -- (Marketwire) -- 02/12/13 -- 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 Athersys, Inc. (NASDAQ: ATHX) and Rexahn Pharmaceuticals, Inc. (NYSE: RNN).
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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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Athersys is developing a patented and proprietary non-embryonic stem cell therapy called MultiStem for the treatment of cardiovascular disease, neurological conditions, and inflammatory and immune conditions, as well as certain other potential applications. In addition, the company is developing novel pharmaceuticals to treat indications such as obesity, and related metabolic conditions such as diabetes.
Rexahn Pharmaceuticals is a clinical stage pharmaceutical company dedicated to developing and commercializing first in class and market leading therapeutics for cancer and other unmet medical needs. Rexahn currently has three key oncology drug candidates in clinical stages, Archexin, RX-3117, and RX-5902 and a robust pipeline of preclinical compounds to treat multiple cancers.
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