FDA Currently Considering Faster Pathway for Drugs Deemed to Offer Societal Benefit

NEW YORK, NY--(Marketwire - Oct 15, 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 MannKind Corporation ( NASDAQ : MNKD ) and Dendreon Corporation ( NASDAQ : DNDN ).

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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 of 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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MannKind focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes and cancer. The company recently announced that it has completed recruiting patients for two Phase 3 clinical studies of AFREZZA, an investigational, ultra rapid-acting mealtime insulin therapy.

Dendreon is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development, commercialization and manufacturing of novel therapeutics. The company recently announced the first patient enrollment and initiation of treatment for the sipuleucel-T European Union open-label study.

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: http://www.paragonreport.com/disclaimer

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FDA Currently Considering Faster Pathway for Drugs Deemed to Offer Societal Benefit