NEW YORK, NY--(Marketwire - Oct 25, 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 Amicus Therapeutics, Inc. (
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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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Amicus Therapeutics is a biopharmaceutical company at the forefront of developing therapies for rare and orphan diseases. The Company is developing orally administered, small molecule drugs called pharmacological chaperones, a novel, first-in-class approach to treating a broad range of human genetic diseases. Amicus recently reported that it has now achieved target enrollment and has 56 patients in its second Phase 3 Fabry Monotherapy study.
Geron is a biopharmaceutical company developing first-in-class therapies for cancer. The company has two lead product candidates in clinical development, GRN1005 and imetelstat. Geron is scheduled to release their third quarter financial results on October 30, 2012. The company in September reported that imetelstat is no longer being considered for the treatment of breast cancer.
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- Pharmaceuticals & Drug Trials
- Geron Corporation