NEW YORK, NY--(Marketwire - Nov 6, 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 XOMA Corporation (
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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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XOMA focuses its antibody research and development on allosteric modulation, which offers opportunities for new classes of therapeutic antibodies to treat a wide range of human diseases. In August the company's lead product gevokizumab received Orphan Drug Designation from the FDA for the treatment of non-infectious.
YM BioSciences is a life sciences product development company advancing a diverse portfolio of promising hematology and cancer-related products at various stages of development. The company recently reported positive interim results from the Phase I/II study of CYT387.
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- Pharmaceuticals & Drug Trials