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Novartis Previews Panobinostat PFS Advantage In Myeloma

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Positive Phase III findings support Novartis’ plan for filing the pan-DAC inhibitor in 2014. The firm’s initial BLA for the compound, seeking accelerated approval in Hodgkin’s lymphoma, was rejected by FDA in 2011.

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Proving Ground For “Breakthrough” Status Coming With Impending User Fee Goals

Novel drug and biologic applications with user fee goals in 2014’s second half cluster around infectious disease – notably hepatitis C, with three “breakthrough” drugs pending, antibiotics and meningitis B vaccines (also designated “breakthroughs”) – and oncology, where the first regulatory tests of the highly anticipated PD-1 immune checkpoint inhibitors are coming up.

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