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

  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 ImmunoGen, Inc. (NASDAQ: IMGN) and Orexigen Therapeutics, Inc. (NASDAQ: OREX).

Access to the full company reports can be found at: www.ParagonReport.com/IMGN www.ParagonReport.com/OREX

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 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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ImmunoGen develops targeted anticancer therapeutics using expertise in cancer biology, engineered antibodies and highly potent cancer-cell killing agents. ImmunoGen's collaborative partners include Amgen, Bayer HealthCare, Biotest, Lilly, Novartis, Roche, and Sanofi. The company recently reported that marketing applications have been submitted for trastuzumab emtansine (T-DM1) in the U.S. and Europe.

Orexigen Therapeutics is a biopharmaceutical company focused on the treatment of obesity. The Company's lead product candidate is Contrave, which has completed Phase III clinical trials and for which a New Drug Application has been submitted and reviewed by the FDA. The company is scheduled to release its third quarter 2012 results on November 7, 2012.

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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