SOURCE: Research Driven Investing
NEW YORK, NY--(Marketwire - Feb 25, 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 Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) and VIVUS, Inc. (NASDAQ: VVUS).
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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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Onyx Pharmaceuticals is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. The company is focused on developing novel medicines that target key molecular pathways. Shares of Onyx spiked sharply last week after reporting results for the fourth quarter and full year 2012. For the full year 2012 Onyx reported revenues of $362.2 million.
On September 17, 2012, Vivus began marketing their weight loss drug, Qsymia, in the U.S. Qsymia is a new FDA-approved prescription medicine that may help some obese adults or some overweight adults who also have weight-related medical problems lose weight and keep the weight off. The company recently announced that European Medicines Agency's confirmed its decision to not recommend the approval of its weight loss drug in the European Union.
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