NEW YORK, NY -- (Marketwire) -- 11/08/12 -- 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 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) and Vertex Pharmaceuticals Inc. (NASDAQ: VRTX).
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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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BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises four approved products and multiple clinical and pre-clinical product candidates. Shares of the company surged to a new all-time high last week after reporting positive results from a late-stage trial of GALNS in the treatment of patients with an enzyme deficiency disease. The company plans to seek regulatory approval sometime next year.
Vertex scientists and their collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. The company has recently entered into an agreement with GlaxoSmithKline to conduct a Phase 2 proof-of-concept study of an all-oral regimen for the treatment of hepatitis C.
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