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New, Quicker Approval Path

Pharmacyclics, J&J's Ibrutinib Wins FDA 'Breakthrough' Tag

By Randy Osborne
Staff Writer

Wednesday, February 13, 2013
Pharmacyclics Inc., with partner Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson, became the latest in a small handful of companies to gain "breakthrough therapy designation," a new category that could let drug developers win approval of their drug candidates based on single, Phase I trials.

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