Improving Trend in FDA First Cycle Review Approvals a Major Factor for Biotech Industry's Success in 2012
November 14, 2012 08:20 ET
Improving Trend in FDA First Cycle Review Approvals a Major Factor for Biotech Industry's Success in 2012
Five Star Equities Provides Stock Research on Biosante Pharmaceuticals and Hemispherx BioPharma
NEW YORK, NY--(Marketwire - Nov 14, 2012) - 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 25 percent year-to-date. Five Star Equities examines the outlook for companies in the Biotech Industry and provides equity research on Biosante Pharmaceuticals Inc. (
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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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BioSante Pharmaceuticals is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante also is developing a portfolio of cancer vaccines, with 17 Phase I and Phase II clinical trials currently on-going. Four of these vaccines have been granted Orphan Drug designation by the FDA.
Hemispherx's platform technology includes large and small agent components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has an extensive number of patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection).
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