U.S. Food and Drug Administration Approved 30% More Drugs in 2012

NEW YORK, NY--(Marketwire - Feb 26, 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 Exelixis, Inc. (NASDAQ: EXEL) and Novogen Ltd. (NASDAQ: NVGN).

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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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Exelixis is focusing its proprietary resources and development efforts exclusively on COMETRIQ, which has been approved by the FDA for the treatment of metastatic medullary thyroid cancer. Exelixis has also established a portfolio of other novel compounds that it believes have the potential to address serious unmet medical needs, many of which are being advanced by partners as part of collaborations.

Novogen is focused on the development of a family of novel anti-cancer drugs based on super-benzopyran and 'stealth' drug technologies. The Company's lead experimental drug candidate is CS-6. Shares of the Novogen were sent soaring earlier this month after reporting an important study showed CS-6 was "highly active" against ovarian cancer stem cells.

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