New Legislation Passed to Help Speed Up FDA Review Process
The Paragon Report Provides Stock Research on SciClone Pharmaceuticals and Chelsea Therapeutics
(firmenpresse) - NEW YORK, NY -- (Marketwire) -- 09/20/12 -- Despite concerns of a global economic slowdown the Biotech Industry has impressed investors with strong gains in 2012. Patent expirations, favorable legislation, and a faster review process have been some of the contributing factors for the industry's current boom. The Paragon Report examines investing opportunities in the Biotechnology Industry and provides equity research on SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) and Chelsea Therapeutics International Ltd. (NASDAQ: CHTP).
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The Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law on July 9, 2012 by President Obama. The law allows the FDA to collect "user fees" to help fund reviews of innovator drugs, medical devices, generic drugs and biosimilars.
"The legislation will enhance the development and review of innovative new therapies through increased transparency and scientific dialogue, advancements in regulatory science and strengthened post-market review. It will also increase the Food and Drug Administration's (FDA) access to external expertise to improve the drug review process," Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood said in a statement.
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SciClone Pharmaceuticals is a revenue-generating, profitable, specialty pharmaceutical company with a substantial commercial business in China and a product portfolio of therapies for oncology, infectious diseases and cardiovascular, urological, respiratory, and central nervous system disorders. The company recently reported a Chinese government-mandated price reduction ZADAXIN.
Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases, including central nervous system disorders. Chelsea is currently pursuing FDA approval in the U.S. for Northera (droxidopa), a novel, late-stage, orally-active therapeutic agent.
The Paragon Report has not been compensated by any of the above-mentioned publicly traded companies. Paragon Report is compensated by other third party organizations for advertising services. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at:
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Datum: 20.09.2012 - 12:20 Uhr
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