Market Access Strategies: Pending Approvals, J&J Plans Cautious Steps For Access To Anti-TB Drug Bedaquiline
This article was originally published in The Pink Sheet Daily
In an interview, Janssen Chairman Paul Stoffels discusses market access issues related to bedaquiline and J&J’s recent decision to free up patents on its HIV therapy Prezista.
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A positive advisory committee for Janssen’s bedaquiline means the second priority review voucher is probably on its way. And it would be the first for an accelerated approval.
FDA’s Anti-Infective Drugs Advisory Committee was fully satisfied with “sputum culture conversion” as a surrogate endpoint for accelerated approval, but turned back a last-minute question from FDA on traditional full approval for the tuberculosis drug bedaquiline.
J&J Worldwide Chairman Paul Stoffels On Precompetitive Alliances, Patent Pools And Tropical Drugs: An Interview With PharmAsia News
For Paul Stoffels, worldwide chairman, pharmaceuticals at Johnson & Johnson, innovation has been a long-time passion. Stoffels is regarded as a specialist in HIV therapies. In 1997, he left Janssen Research Foundation to become the CEO of Tibotec-Virco, which he transformed from a technology-based research company into an integrated R&D organization focused on the discovery and development of new drugs and diagnostics for HIV/AIDS and infectious diseases.