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 Biosante Pharmaceuticals Inc. (
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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BioSante is developing a portfolio of cancer vaccines, with 17 Phase I and Phase II clinical trials currently on-going. Four of these vaccines have been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA). The company recently reported that the independent Data Monitoring Committee has recommended that the LibiGel safety study should continue as per the FDA-agreed protocol.
Cell Therapeutics is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. The company recently reported OPAXIO has been granted orphan-drug designation by the FDA for the treatment of glioblastoma multiforme, a malignant brain cancer.
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