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Tuesday, December 13, 2016 8:02:33 AM
21st Century Cures Act is expected by industry analysts to speed up drug development by accelerating the regulatory approval process
Pluristem’s program for CLI was already selected to rapid pathways in both Europe and Japan, where legislation similar to the 21st Century Cures Act has already been passed
HAIFA, Israel, Dec. 13, 2016 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (PSTI) (PSTI), a leading developer of placenta-based cell therapy products, welcomes and applauds the U.S. Congress’ passage of the 21st Century Cures Act. Pluristem believes its PLX-PAD and PLX-R18 cell therapies will meet the criteria outlined by the Act as advanced regenerative therapies that can treat a wide range of disease. The 21st Century Cures Act is expected by industry analysts to speed up drug development by accelerating the regulatory approval process, among other means.
“The 21st Century Cures Act is an extremely significant healthcare legislation that may have a direct and beneficial impact on Pluristem’s clinical development programs and progress towards approval for our cell therapies,” stated Pluristem CEO Zami Aberman. “Pluristem has a robust portfolio of cell therapies that are designed to treat severe diseases where there is a high unmet medical need. The 21st Century Cures Act should allow for early patient access to cell therapies, while also creating medical and economic benefits for the U.S. healthcare system. The passage of this legislation in the world’s largest healthcare market reinforces Pluristem’s strategy of pursuing accelerated pathways to market around the globe.”
Pluristem’s clinical program for CLI is already being developed via both Europe’s Adaptive Pathways project and the Japanese PMDA under the new legislation for conditional marketing authorization for regenerative therapies.
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