SOURCE: Paragon Financial Limited
NEW YORK, NY--(Marketwire - Oct 22, 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 Aegerion Pharmaceuticals, Inc. (NASDAQ: AEGR) and CytRx Corporation (NASDAQ: CYTR).
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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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Aegerion Pharmaceuticals is an emerging biopharmaceutical company focused on the development and commercialization of novel, life-altering therapeutics to treat debilitating and often fatal rare diseases. Shares of the company soared last Thursday after reporting the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA recommended approval of lomitapid for the treatment of Homozygous Familial Hypercholesterolemia.
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. The CytRx oncology pipeline includes two programs in clinical development for cancer indications. The company recently initiated a single-center Phase 1b clinical trial for aldoxorubicin in the treatment of metastatic solid tumors.
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