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March 13, 2013
13:09 EDTNAVB, CAHFDA approves Navidea Lymphoseek injection for use in lymphatic mapping
Navidea Biopharmaceuticals (NAVB) announced U.S. Food and Drug Administration approval of Lymphoseek Injection, a novel product indicated for use in lymphatic mapping procedures to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma. Lymphoseek will be sold and distributed in the U.S. on an exclusive basis by Cardinal Health (CAH).
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June 12, 2013
10:33 EDTCAHCardinal Health management to meet with Cleveland Research
Meeting to be held in Denver on June 14 hosted by Cleveland Research.
09:03 EDTNAVBNavidea's Lymphoseek shows positive meta-analysis results
Navidea announced results from a meta-analysis study of Lymphoseek (technetium Tc 99m tilmanocept) Injection, a novel, receptor-targeted, small-molecule radiopharmaceutical. The study compared Lymphoseek performance data from a pre-planned interim analysis of its Phase 3 clinical trial versus published data from the ACOSOG Z-0360 trial which was done using radiolabeled sulfur colloid. Results demonstrated that Lymphoseek identified sentinel lymph nodes in subjects with squamous cell carcinoma of the head or neck with a False Negative Rate of 2.56%, whereas sulfur colloid demonstrated an FNR of 10%. Lymphoseek identified SLNs with an overall accuracy of 99%, versus an overall accuracy of sulfur colloid of 97%.
June 11, 2013
09:03 EDTNAVBNavidea announces positive results from study of Lymphoseek Injection
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June 10, 2013
16:19 EDTNAVBNavidea announces results from two breast cancer studies
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