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FDA Rejects ITM-11 Radiopharmaceutical, Stalling Rival to Novartis Therapy

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Source: STAT
FDA Rejects ITM-11 Radiopharmaceutical, Stalling Rival to Novartis Therapy
Photo: STAT
TL;DR

The FDA rejected ITM-11, ITM Isotope Technologies Munich’s radiopharmaceutical for gastroenteropancreatic neuroendocrine tumors, due to manufacturing issues, halting a potential rival to Novartis’ therapy; early ITM data suggested ITM-11 could extend progression-free survival (23.9 months vs 14.1 months with everolimus).

Topics:businessbiotech#biotech#fda#gep-nets#itm-isotope-technologies-munich#manufacturing-issues#radiopharmaceuticals
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