NEW YORK, NY -- (Marketwire) -- 03/14/13 -- 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 Acura Pharmaceuticals, Inc. (NASDAQ: ACUR) and Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS).
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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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The first two commercial products utilizing Acura's tamper-resistant technologies are OXECTA and NEXAFED. In addition, Acura has seven other abuse deterrent products in development: Hydrocodone bitartrate/acetaminophen tablets, Oxycodone HCl/acetaminophen tablets, Hydromorphone tablets, Morphine tablets, Oxymorphone tablets, Tramadol tablets and Methadone tablets. The company recently announced that Nexafed will now be stocked by chain drug store KERR DRUG.
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Vosaroxin is currently being evaluated in our Phase 3 VALOR trial, a multi-national, randomized, double-blind, placebo-controlled, pivotal trial of vosaroxin in combination with cytarabine in patients with relapsed or refractory AML.
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