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FDA Considering Allowing Developers of Critical Drugs/Treatments to Conduct Smaller, Faster Clinical Trials

NEW YORK, NY--(Marketwire - Nov 7, 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. Paragon Report examines investing opportunities in the Biotech Industry and provides equity research on Rosetta Genomics Ltd. ( NASDAQ : ROSG ) and Infinity Pharmaceuticals Inc. ( NASDAQ : INFI ).

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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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Rosetta develops and commercializes a full range of microRNA-based molecular diagnostics. Shares of the company surged over 20 percent after it was reported that the New York State Department of Health has given final approval for its miRview lung assay. With the approval Rosetta can now continue to offer its miRview lung assay in all 50 U.S. states.

Infinity Pharmaceuticals is a discovery and development company, focuses on discovering, developing, and delivering medicines to patients for diseases with significant unmet need. Shares of the company fell sharply earlier this week despite reporting a profit of $18.40 million or $0.52 per share in the third quarter, compared to a loss of $11.94 million or $0.45 per share in the year-ago quarter. For the full-year 2012 the company expects a net loss of between $35 million to $45 million.

The Paragon Report has not been compensated by any of the above-mentioned publicly traded companies. Paragon Report is compensated by other third party organizations for advertising services. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at: