Drugs and Treatments Deemed to Offer Societal Benefit Could See Faster FDA Pathway

  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 Celsion Corporation (NASDAQ: CLSN) and Aastrom Biosciences, Inc. (NASDAQ: ASTM).

Access to the full company reports can be found at:

www.ParagonReport.com/CLSN

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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 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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Celsion is a late-stage biopharmaceutical company dedicated to the development of innovative, targeted therapies that address unmet medical needs in oncology. By applying their unique heat-activated liposomal drug delivery system to proven anti-cancer agents, they can deliver high concentrations of chemotherapeutics directly to the tumor site.

Aastrom Biosciences is dedicated to the development of stem cell treatments for critical cardiovascular diseases. Aastrom is currently evaluating its autologous cellular therapies in late-stage U.S. clinical trials in the treatment of critical limb ischemia (CLI) and dilated cardiomyopathy (DCM). The company recently reported that their President and CEO Tim M. Mayleben plans to retire.

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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