“Breakthrough” Therapies: Pharmacyclics Gains More Access, Certainty For Ibrutinib
Company Chief Medical Officer Kunkel says FDA has talked about manufacturing and trial design for its breakthrough designee much earlier than would be expected with a typical application.
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Sponsors of would-be breakthrough therapies need to move as quickly as FDA is acting, from responding to emails to ramping up manufacturing so they can start trials earlier.
FDA on average sent about 20 more information requests during breakthrough product reviews than others in the Program, according to interim assessment of the PDUFA V review system. Assessment could support higher funding for breakthrough program in next user fee round.
When was the last time a life science venture firm spent close to $50 million all in one go? It doesn't happen often, but Aisling Capital and Clarus Ventures have each put up $48.5 million for a tiny slice of sales royalties from ibrutinib, a promising cancer drug that could receive FDA approval this calendar year or early next.