Pharmacyclics Gains ‘Breakthrough’ Status for Cancer Drug
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Pharmacyclics Inc., a drugmaker developing an experimental therapy for blood cancers, won “breakthrough” status from U.S. regulators for the medicine that may lead to quicker marketing approval.
Pharmacyclics and its partner, New Brunswick, New Jersey-based Johnson & Johnson, will submit the therapy, ibrutinib, to the Food and Drug Administration for approval before the end of the year, the companies said today in separate statements.