New Legislation Passed to Help Speed Up FDA Review Process
The Paragon Report Provides Stock Research on Geron and Cytokinetics
(firmenpresse) - NEW YORK, NY -- (Marketwire) -- 09/17/12 -- 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 Geron Corporation (NASDAQ: GERN) and Cytokinetics, Inc. (NASDAQ: CYTK).
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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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Geron is a biopharmaceutical company developing first-in-class therapies for cancer. The Company has two lead product candidates in clinical development, imetelstat and GRN1005. Geron recently announced that it is continuing its randomized Phase 2 study of imetelstat in advanced non-small cell lung cancer (NSCLC).
Cytokinetics is a clinical-stage biopharmaceutical company focused on the discovery and development of novel small molecule therapeutics that modulate muscle function for the potential treatment of serious diseases and medical conditions. Cytokinetics' lead drug candidate from its cardiac muscle contractility program, omecamtiv mecarbil, is in Phase II clinical development for the potential treatment of heart failure.
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: 17.09.2012 - 06:20 Uhr
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