Tag Archives: ibrutinib

Ibrutinib's Breakthrough to Market

FDA’s new Breakthrough Therapies designation sped Pharmacyclics/J&J’s ibrutinib (brand name: Imbruvica) through regulatory review in four months, based on Phase 2 studies. Pricing and access issues, though, may not get resolved so quickly.
Posted in Biotech, FDA, healthcare, Market Access, Orphan Drugs, pricing, Regulatory, Sales, Strategy | Also tagged , , | 8 Comments
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