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Biotech Industry Experiencing a Higher Amount of FDA New Drug Approvals in 2012
November 26, 2012 08:20 ET
Biotech Industry Experiencing a Higher Amount of FDA New Drug Approvals in 2012
Five Star Equities Provides Stock Research on Discovery Laboratories and Cardium Therapeutics
NEW YORK, NY--(Marketwire - Nov 26, 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 Discovery Laboratories, 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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Discovery Labs believes that its proprietary technologies make it possible, for the first time, to develop a significant pipeline of products to address a variety of respiratory diseases for which there frequently are few or no approved therapies. The Company anticipates product availability for SURFAXIN early in the second quarter of 2013 and its initial AFECTAIR device for infants in December 2012.
Cardium's lead clinical development product candidate Generx is a DNA-based angiogenic biologic intended for the treatment of patients with myocardial ischemia due to coronary artery disease. The company recently reported that their patent portfolio now includes allowed and issued patents covering its gene therapy approach both in Europe and in the United States, with competing patent applications licensed and pursued by Boston Scientific having been successfully overcome in both Europe and the U.S.
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