Novartis’ Panobinostat Review Pits Progression-Free Survival Against Toxicities
This article was originally published in The Pink Sheet Daily
FDA advisory committee will also consider whether appropriate dose was selected for Phase III trial of the oral deacetylase inhibitor in patients with relapsed multiple myeloma.
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Expanded Access Opens Window For Dose Optimization Studies In Cancer
The period after completion of pivotal trials but ahead of FDA approval provides an opportunity for oncology drug sponsors to conduct badly needed dose comparison trials, a multi-stakeholder panel says at the annual Conference on Clinical Cancer Research.
Diabetes Drugs: US FDA Proposes Hypoglycemia Efficacy Endpoints, With Limits
Reduction in the risk of hypoglycemia level 2 and 3 events, along with either a reduction or maintenance of an acceptable hemoglobin A1C, is a clinically relevant efficacy endpoint for drug development in Types 1 and 2 diabetes, FDA states in new draft guidance.
Intercept’s Ocaliva: ‘Dangling’ PBC Indication At Risk As Near-Term NASH Approval Looks Unlikely
Accelerated approval for primary biliary cholangitis in 2016 came with three postmarketing requirements, but studies were terminated early; firm working toward sNDA submission in 2023 for regular approval, but US FDA says reports already are overdue and it expects to take PBC indication back to an adcomm.