NEW YORK, NY--(Marketwire - Oct 29, 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 Ariad Pharmaceuticals, Inc. (NASDAQ: ARIA) and Galena Biopharma Inc. (NASDAQ: GALE).
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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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ARIAD Pharmaceuticals is an emerging global oncology company focused on the discovery, development and commercialization of medicines to transform the lives of cancer patients. The company recently reported that the FDA has accepted for filing the New Drug Application (NDA) for accelerated review of ARIAD's leukemia drug Ponatinib.
Galena Biopharma is focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using targeted biotherapeutics. The company recently announced it presented positive results from the Phase 1/2 clinical trial of NeuVax at the 27th Annual Meeting of the Society for Immunotherapy of Cancer.
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