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 Alexza Pharmaceuticals and EntreMed
(firmenpresse) - NEW YORK, NY -- (Marketwire) -- 11/27/12 -- 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 Alexza Pharmaceuticals, Inc. (NASDAQ: ALXA) and EntreMed, Inc. (NASDAQ: ENMD).
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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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Alexza Pharmaceuticals is an emerging specialty pharmaceutical company focused on the development and commercialization of novel, proprietary products for the treatment of acute and intermittent conditions. The company expects a decision to be made on its New Drug Application for its lead program, ADASUVE, by December 21, 2012.
EntreMed is a clinical-stage pharmaceutical company developing a new generation of multi-mechanism drugs for the treatment of cancer and inflammatory diseases. EntreMed's drug candidates target disease cells and the blood vessels that nourish them. Shares of the company surged Monday after reporting the publication of positive preclinical results for ENMD-2076, its lead compound.
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Datum: 27.11.2012 - 13:20 Uhr
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