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February 4, 2013
09:27 EDTNAVBNavidea announces collaboration with Maimonides Medical Center
Navidea Biopharmaceuticals has entered into an agreement to collaborate with Maimonides Medical Center to investigate the utility of Lymphoseek Injection in lymphatic mapping procedures for colorectal cancer. Dr. Danny Sherwinter, surgeon and the Director of the Department of Minimally Invasive & Bariatric Surgery at Maimonides Medical Center in Brooklyn, NY, will lead the investigator-initiated clinical study. This open-label evaluation, expected to start enrollment in early 2013, will be performed at Maimondes and will include the assessment of lymph nodes from up to 40 colon cancer subjects. According to the American Cancer Society, approximately 140,000 new cases of colorectal cancer are expected to be diagnosed in the United States annually1 while worldwide annual diagnosis is over 1.2 million.
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October 15, 2014
09:20 EDTNAVBOn The Fly: Pre-market Movers
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08:03 EDTNAVBNavidea names Gonzalez CEO
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08:01 EDTNAVBNavidea names Gonzalez CEO
07:03 EDTNAVBNavidea announces FDA sNDA approval for Lymphoseek extended use
Navidea Biopharmaceuticals announced that the U.S. Food and Drug Administration has approved the Supplemental New Drug Application for the expanded use of Lymphoseek injection for lymphatic mapping in solid tumors and adding Sentinel Lymph Node detection for breast cancer and melanoma to the approved indications. The FDA also allowed expanded utilization of Lymphoseek with or without scintigraphic imaging to enable pre-operative imaging and mapping of lymph nodes to facilitate node localization during surgical procedures. Lymphoseek will be immediately available using existing reimbursement codes for this expanded population of cancer patients. In the approval action letter, the FDA also outlined a post-marketing requirement for initiation of a pediatric study in solid tumor cancer with a target date for submission in 2018.

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