Improving Trend in FDA First Cycle Review Approvals a Major Factor for Biotech Industry's Success in 2012

NEW YORK, NY--(Marketwire - Jan 7, 2013) - The Biotech Industry has skyrocketed in 2012 as an increase in the number of new drug approvals has boosted investor optimism within the industry. The iShares Nasdaq Biotechnology Index Fund (IBB) and the SPDR S&P Biotech ETF (XBI) have both gained over 30 percent year-to-date. Five Star Equities examines the outlook for companies in the Biotech Industry and provides equity research on Navidea Biopharmaceuticals Inc. (NYSE: NAVB) and NuPathe Inc. (NASDAQ: PATH).

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"In 2011, the U.S. FDA approved 30 new drugs, compared to 21 in 2010," S&P Capital IQ wrote in a note. "Through September 2012, the year-to-date total was 22. We see an improving trend for FDA first cycle review approvals and a rise in the rate of new drug approvals for rare diseases, which we think is helping to boost investor sentiment for the agency, after years of criticism stemming from inconsistency in making and communicating its decisions."

Another key factor in the Biotech Industry's success has been the "patent cliff" major pharmaceuticals have faced in 2012. Major drug manufacturers have looked to biotech companies to help offset major revenue losses from expiring patents as it is less time consuming than developing new drugs through R&D.

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Navidea Biopharmaceuticals, a leader in precision diagnostics, is a biopharmaceutical company developing novel radiopharmaceutical imaging agents to help identify the presence and status of disease and enable better diagnostic accuracy, clinical decision-making and ultimately patient care. The company recently announced it has accrued sufficient subjects in its NEO3-06 study to enable the company to conduct a pre-planned interim analysis.

NuPathe is a specialty pharmaceutical company focused on innovative neuroscience solutions for diseases of the central nervous system including neurological and psychiatric disorders. The company recently reported it has received a notice of allowance from United States Patent and Trademark Office. Once the patent is issued it will provide Zecuity, a treatment for migraines, with additional patent protection.

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