NEW YORK, NY -- (Marketwire) -- 02/11/13 -- 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 AEterna Zentaris Inc. (NASDAQ: AEZS) and Oncolytics Biotech, Inc. (NASDAQ: ONCY)(TSX: ONC).
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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Aeterna Zentaris' AEZS-108 is the first intravenous drug in advanced clinical development that directs the chemotherapy agent specifically to Luteinizing Hormone Releasing Hormone-receptor expressing tumors, resulting in more targeted treatment with less damage to healthy tissue. AEZS-108 has been granted orphan drug designation by the FDA and orphan medicinal product designation from the European Medicines Agency for the treatment of ovarian cancer.
Oncolytics is a biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Shares of the company spiked sharply last week after reporting results from a clinical trial of REOLYSIN in combination with chemotherapy drugs was effective in shrinking tumors in 95 percent of patients tested.
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