|By Marketwire .||
|October 18, 2012 08:20 AM EDT||
NEW YORK, NY -- (Marketwire) -- 10/18/12 -- 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 Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE) and ISIS Pharmaceuticals, Inc. (NASDAQ: ISIS).
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Under the new pathway the FDA would allow developers of such drugs to conduct smaller, faster clinical trials, and provide a "special medical use" label which would allow doctors to administer drugs to patients with critical needs. 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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Ampio Pharmaceuticals develops innovative proprietary drugs for inflammation, eye disease, kidney disease, CNS disease, metabolic disease and male sexual dysfunction. The product pipeline includes new uses for previously approved drugs and new molecular entities. The company recently reported it has entered into a definitive agreement with Ethypharm Ltd. for the manufacturing of Zertane.
Isis is exploiting its leadership position in antisense technology to discover and develop novel drugs for its product pipeline and for its partners. Isis' broad pipeline consists of 25 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic, severe and rare diseases, and cancer. Shares of the company fell over 20 percent Tuesday after a FDA committee linked the company's cholesterol drug Kynamro to both benign and cancerous tumors.
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