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News Breaks
March 13, 2013
13:09 EDTCAH, NAVBFDA 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).
News For NAVB;CAH From The Last 14 Days
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December 18, 2014
12:17 EDTCAHBayer, Cardinal Health sign contract manufacturing agreement for Xofigo
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December 15, 2014
13:12 EDTNAVBNavidea's Macrophage unit announces presentation of data using tilmanocept
Macrophage Therapeutics, a newly created business unit of Navidea Biopharmaceuticals, hosted a conference where data was presented using Manocept platform compound, tilmanocept, that was generated by independent academic collaborators with expertise in the HIV/AIDS, cancer, tuberculosis, rheumatoid arthritis and cardiovascular disease therapeutic areas. The technical presentations highlighted tilmanocept’s ability to target activated macrophages implicated in pathology. Specifically data were presented in: 1. Kaposi’s Sarcoma cells from human tumor extracts that contain tumor associated macrophages and are often infected with HIV. Data demonstrated that a generic anticancer agent that has no direct activity vs. HIV, conjugated to tilmanocept killed the CD-206 positive TAM’s. 2. Tilmanocept labeled with a fluorescent reporter demonstrated a high degree of co-localization with tuberculosis-associated activated macrophages, which express CD-206, from TB granulomas extracted from human and primate tissue. 3. Rheumatoid Arthritis - Data presented indicated that tilmanocept containing a florescent reporter molecule demonstrates selective localization solely into rheumatoid affected joints in a whole live animal model of RA. Navidea director Michael M. Goldberg, M.D., who is leading Navidea’s Macrophage Therapeutics efforts, commented, “the data presented today will shortly be enhanced by data from ongoing studies to further advance this novel immunotherapy approach. We are in the process of assembling a world class Scientific Advisory Board that will assist in guiding our research further. We look forward to regularly updating the market with new developments, potential partnerships and results from our ongoing studies.”
09:28 EDTNAVBNavidea trading halted, pending news
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08:23 EDTCAHCardinal Health story not fully appreciated, says RW Baird
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December 11, 2014
11:31 EDTCAHCardinal Health to hold an analyst and investor meeting
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December 10, 2014
07:32 EDTNAVBNavidea forms Macrophage Therapeutics business unit
Navidea Biopharmaceuticals announced the formation of a new business unit, Macrophage Therapeutics, to further explore therapeutic applications for the Manocept platform. The Manocept platform serves as the molecular backbone of Navidea’s FDA-approved, activated macrophage-targeting agent, Lymphoseek injection. Preclinical data being developed by the company using tilmanocept linked to various therapeutic agents suggest that tilmanocept’s binding affinity to CD206 receptors demonstrates the potential for this technology to be useful in treating diseases linked to the over-activation of macrophages. This includes various cancers as well as autoimmune, infectious, cardiovascular, and central nervous system diseases. Navidea intends to structure Macrophage Therapeutics such that it will remain under Navidea’s control enabling existing shareholders to capture potential future value, but also allow funding of future development in a standalone, non-dilutive manner to Navidea’s existing shareholders. Current board members Michael M. Goldberg, M.D. and Eric K. Rowinsky, M.D. and Navidea’s Chief Scientific Officer, Frederick O. Cope, Ph.D. have been appointed to focus on the launch of the new unit.
December 8, 2014
11:30 EDTCAHLeerink generics pharmaceutical analyst holds analyst/industry conference call
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