FDA Considering Faster Pathway for Obesity Treatments, Life-Saving Antibiotics and Other Drugs Deemed to Offer Societal Benefit
The Paragon Report Provides Stock Research on Arena Pharmaceuticals and VIVUS
(firmenpresse) - NEW YORK, NY -- (Marketwire) -- 11/02/12 -- 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 Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and VIVUS, Inc. (NASDAQ: VVUS).
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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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Arena Pharmaceuticals is a biopharmaceutical company focused on discovering, developing and commercializing novel drugs for weight management, cardiovascular disease, inflammation and other disorders. The company's weight loss drug, Belviq, is currently under review by the Drug Enforcement Administration.
VIVUS is a biopharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity, sleep apnea, diabetes and sexual health for U.S., Europe and other world markets. The company recently submitted an amendment to the Risk Evaluation and Mitigation Strategy for Qsymia, which would allow dispensing through a broader range of pharmacies.
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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Datum: 02.11.2012 - 07:20 Uhr
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