FDA Considering Faster Approval Process for Developers of Drugs for Deadly or Debilitating Diseases

  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 ImmunoCellular Therapeutics Ltd. (NYSE: IMUC) and Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX).

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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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ImmunoCellular's products and technologies are designed to harness the power of the immune system to improve the treatment of cancer. The company is developing active immunotherapies that target not only regular tumor cells, but also the cancer stem cells believed to cause cancer growth and recurrence. ImmunoCellular is scheduled to release it third quarter financial results on November 14, 2012.

Idenix Pharmaceuticals is engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases. Idenix's current focus is on the treatment of hepatitis C virus infections. The company has previously discovered and developed antivirals for the treatment of hepatitis B virus and HIV/AIDS.

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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