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 Athersys, 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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Athersys is developing its MultiStem cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product platform for disease indications in the cardiovascular, neurological, inflammatory and immune disease areas. The company recently reported a publication has indicated that MultiStem treatment may reduce inflammation and promote reparative processes following acute brain injury.
ADVENTRX Pharmaceuticals is a biopharmaceutical company developing proprietary product candidates to treat various diseases and conditions. The company's lead product candidate, ANX-188, has potential to reduce ischemic tissue injury and end-organ damage. ADVENTRX has engaged Theradex Systems to manage the company's upcoming phase 3 study of ANX-188 in sickle cell disease.
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- Pharmaceuticals & Drug Trials