NEW YORK, NY -- (Marketwire) -- 10/16/12 -- 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 StemCells, Inc. (NASDAQ: STEM) and Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX).
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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StemCells, Inc. is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. The company recently reported that it was awarded a broad U.S. patent covering expandable liver cells. Shares of StemCells have gained over 140 percent in the last three months.
Lexicon is a biopharmaceutical company focused on discovering breakthrough treatments for human disease. Lexicon currently has four drug programs in mid-stage development for diabetes, carcinoid syndrome, irritable bowel syndrome and rheumatoid arthritis. Shares of the company soared over 12 percent last Friday after reporting positive results from their Phase II Trial of LX 1032 in in the treatment of carcinoid syndrome.
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