NEW YORK, NY -- (Marketwire) -- 10/22/12 -- 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 AspenBio Pharma, Inc. (NASDAQ: APPY) and Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS).
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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 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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AspenBio Pharma is an in vitro diagnostic company focused on the clinical development and commercialization of its blood-based appendicitis test. The company announced that it plans to initiate a pivotal study in the fourth quarter of 2012 for its blood-based appendicitis test.
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, vosaroxin, in multiple indications to improve the lives of people with cancer.
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:
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