Sharp Increase in FDA Drug Approvals a Major Factor in Biotech Industry's Success
RDInvesting Provides Stocks Research on XOMA and EntreMed
NEW YORK, NY -- (Marketwire) -- 02/26/13 -- A sharp increase in drug approvals and mergers and acquisitions combined to create a bull market for the Biotechnology Industry in 2012. The iShares NASDAQ Biotechnology Index (IBB), the SPDR S&P Biotech ETF (XBI) and the First Trust Amex Biotechnology Index ETF (FBT) have all gained over 20 percent in the past year, outperforming the broader markets by a good margin. Research Driven Investing examines investing opportunities in the Biotech Industry and provides equity research on XOMA Corporation (NASDAQ: XOMA) and EntreMed Inc. (NASDAQ: ENMD).
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Bloomberg recently reported drug approvals by the U.S. Food and Drug Administration reached a 15 year high in 2012. The FDA approved a total of 39 novel medicines last year, an increase of 30 percent when compared to a year ago. Oncology drugs lead the way with 11 new drugs approved last year. Over the last ten years the number of FDA approvals had averaged roughly 23 a year. The passage of the Prescription Drug User Fee Act (PDUFA) played a major role in the sharp increase in approvals.
The PDUFA "has provided critical resources for improving the quality and timeliness of premarket review of drugs," said FDA spokeswoman, Sandy Walsh. "These accomplishments could not have been achieved without the innovations of the biopharmaceutical industry and the dedication and skill of FDA's drug review staff."
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XOMA's world-class monoclonal antibody technologies have contributed to the development of marketed biologics with a total of more than $1 billion in annual sales and for which XOMA received substantial royalties. The company also has a strong track record of product discovery and development collaborations with pharmaceutical and biotechnology companies and the U.S. government and has licensed certain of its fundamental technologies to more than 60 companies.
EntreMed is a clinical-stage pharmaceutical company employing a drug development strategy primarily in the United States and China to develop targeted therapeutics for the global market. Its lead compound, ENMD-2076, has completed several Phase 1 studies in solid tumors, multiple myeloma, and leukemia, and is currently completing a multi-center Phase 2 study in ovarian cancer.
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