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Manufacturing issues plague Navidea cancer tracing agent; FDA rejects

This article was originally published in Scrip

Executive Summary

Shares of Navidea Biopharmaceuticals plummeted 35% on 11 September following the firm's revelation after the markets closed the day before that the US FDA had rejected the company's new drug application (NDA) for its radioactive diagnostic tracing agent Lymphoseek (tilmanocept) for use in intraoperative lymphatic mapping (ILM), a surgical oncology procedure used primarily in patients with breast cancer and melanoma to determine if disease has spread to the lymph nodes.

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