NEW YORK, NY--(Marketwire - Oct 26, 2012) - The Food and Drug Administration Commissioner Margaret Hamburg has told scientific advisers that the FDA is considering a faster pathway for obesity treatments, life-saving antibiotics and other drugs deemed to offer societal benefit. The Paragon Report examines investing opportunities in the Biotech Industry and provides equity research on Chelsea Therapeutics International Ltd. (NASDAQ: CHTP) and Cytori Therapeutics Inc. (NASDAQ: CYTX).
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Under the new pathway the FDA would allow developers of such drugs to conduct smaller, faster clinical trial, and provide a "special medical use" label which would allow doctors to administer drugs to patients with critical need. Hamburg has said that the FDA needs to take into account the needs people with deadly or debilitating diseases that may be willing to take on the risks of unproven drugs.
"A pathway that would allow products to come to market faster but would ensure they were used only in patients where there was an applicable risk-benefit situation would be good," said Pew Health Group's Allan Coukell, deputy director of medical programs. "It would be good for developers, for companies and it would be good for public health."
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Chelsea Therapeutics specializes in the acquisition and development of innovative products and technologies that address important unmet medical needs or offer alternatives to current methods of treatment. In 2011, Chelsea submitted its first New Drug Application to the FDA seeking approval to market droxidopa for the treatment of symptomatic Neurogenic OH.
Cytori Therapeutics, Inc. is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and repair soft tissue defects. The company recently reported that the first patient was treated in the company's U.S. cell therapy heart failure trial.
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