|By Marketwire .||
|October 16, 2012 08:20 AM EDT||
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 Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) and Hemispherx BioPharma, Inc. (NYSE: HEB).
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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Savient Pharmaceuticals is a specialty biopharmaceutical company focused on developing and commercializing KRYSTEXXA (pegloticase) for the treatment of chronic gout in adult patients refractory to conventional therapy. The company is scheduled to release its third quarter 2012 earnings on October 29, 2012.
Hemispherx Biopharma is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. The company recently reported that a FDA advisory committee will review Ampligen for Chronic Fatigue Syndrome. The date of the review has been tentatively set for December 20, 2012.
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