NVS - Novartis halts radioligand therapy production in U.S. and Italy over quality issues

Novartis (NYSE:NVS) (OTCPK:NVSEF) announced on Thursday that the company decided to pause production at its radioligand therapy manufacturing sites in Ivrea, Italy, and Millburn, New Jersey, after finding quality issues. The production halt has prompted the company to temporarily suspend deliveries of Lutathera in the U.S. and Canada and Lu-PSMA-617, branded as Pluvicto in the U.S. There will be some delays to Lutathera deliveries in Europe and Asia, where supplies will come from Novartis’ (NVS) radioligand therapy production site in Zaragoza, Spain. The Swiss pharma giant is currently investigating the matter, and pending a resolution, it expects to resume some supplies within the next six weeks. Notably, the company announced that it is suspending the screening and enrollment for global studies on Lu-PSMA-617 and U.S and Canadian trials for Lutathera.

For further details see:

Novartis halts radioligand therapy production in U.S. and Italy over quality issues