Novartis reports hitch with SOM230 Cushing’s therapy in pipeline update
This article was originally published in Scrip
Executive Summary
Novartis has withdrawn its US approval application for SOM230 (pasireotide) in the orphan indication of Cushing's disease, citing "an issue related to chemistry, manufacturing and controls". It said it would resubmit the application – which was first filed in June – following further discussion with the FDA.