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 Amgen and Regeneron Pharmaceuticals
NEW YORK, NY--(Marketwire - Nov 23, 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 Amgen, Inc. (NASDAQ: AMGN) and Regeneron Pharmaceuticals Inc. (NASDAQ: REGN).
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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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Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses. The company reported revenues in the third quarter of $4.3 billion, an increase of 10 percent when compared to the year ago quarter.
Regeneron markets three products in the United States, EYLEA Injection, ZALTRAP Injection for Intravenous Infusion, and ARCALYST Injection for Subcutaneous Use. ZALTRAP is co-commercialized with Sanofi. Shares of the company spiked last Friday after reporting it had gained backing from the Committee for Medicinal Products for Human Use of the European Medicines Agency for their cancer drug Zaltrap.
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