U.S. drugmakers cheer 'speed lane' for breakthrough therapies

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U.S. drugmakers cheer 'speed lane' for breakthrough therapies

By Toni Clarke WASHINGTON (Reuters) - A new regulatory pathway could shave years off the traditional drug approval process in the United States, according to some companies whose drugs have been given "breakthrough therapy" designation by the U.S. Food and Drug Administration. Speaking at a briefing in Washington to raise awareness of the drug review process, Dr. Jay Siegel, head of global regulatory affairs at Johnson & Johnson, said he expects two years to be knocked off the time it would typically take the FDA to review ibrutinib, the company's experimental cancer drug. ...

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