New Legislation Passed to Help Speed Up FDA Review Process
The Paragon Report Provides Stock Research on Pluristem Therapeutics and Cell Therapeutics
(firmenpresse) - NEW YORK, NY -- (Marketwire) -- 09/10/12 -- 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 Pluristem Therapeutics Inc. (NASDAQ: PSTI) and Cell Therapeutics Inc. (NASDAQ: CTIC).
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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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Pluristem Therapeutics is a leading developer of placenta-based cell therapies. The Company's patented PLX cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. The company recently reported that a third critically ill patient has been successfully treated with their PLX cells.
Cell Therapeutics is a biopharmaceutical company focused on developing and commercializing novel agents that seek to improve the safety and efficacy of existing standard-of-care cancer treatments, and those that may have unique, new mechanisms to kill cancer cells. The company recently reported that they will provide an update on the Pixuvri launch and pacritinib pivitoal trial status at the Annual Rodman & Renshaw Global Investment Conference. Shares of company surged nearly 30 percent Friday.
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: 10.09.2012 - 06:20 Uhr
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