Biotech Industry Looks to Benefit From New Legislation Passed to Help Speed Up FDA Reviewal Process
The Paragon Report Provides Stock Research on Dendreon and Keryx Biopharmaceuticals
(firmenpresse) - NEW YORK, NY -- (Marketwire) -- 09/11/12 -- 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 Dendreon Corporation (NASDAQ: DNDN) and Keryx Biopharmaceuticals (NASDAQ: KERX).
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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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Dendreon applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy (ACI) product candidates designed to stimulate an immune response in a variety of tumor types. The company in July announced it would close its NJ manufacturing plant in attempts to help reduce annual cost by $150 million a year.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease. The Phase 3 clinical program of Zerenex for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA.
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: 11.09.2012 - 06:20 Uhr
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