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News Breaks
February 18, 2014
07:36 EDTNAVBNavidea announces priority review for sNDA to expand Lymphoseek labeling
Navidea Biopharmaceuticals announced that the U.S. Food and Drug Administration has accepted the Supplemental New Drug Application and granted a Priority Review for the expanded use of Lymphoseek Injection indicated for sentinel lymph node detection in patients with head and neck cancer. Under the Prescription Drug User Fee Act, the FDA has set a target review date for the Lymphoseek sNDA of June 16. The FDA grants priority review status to drug applications that may offer a significant improvement in treatment over existing options. Lymphoseek is currently approved for use in lymphatic mapping procedures performed to aid in the diagnostic evaluation of lymph nodes draining a primary tumor in patients with breast cancer and melanoma.
News For NAVB From The Last 14 Days
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April 27, 2015
07:33 EDTNAVBNavidea divests NAV5001 to Alseres
Navidea Biopharmaceuticals (NAVB) announced that it has entered into an agreement with Alseres Pharmaceuticals (ALSE) to terminate the sub-license agreement dated July 31, 2012 for research, development and commercialization of NAV5001, an agent in Phase 3 clinical development for early detection of Parkinsonís disease. Navidea previously announced its intention to decrease its R&D expenses by divesting its non-core neuroimaging assets. This agreement follows through on the companyís commitment to decrease cash burn while moving these neuroimaging programs forward. Under the terms of this agreement, Navidea will transfer the NAV5001 IND, all data, clinical materials, regulatory files, patents, know-how, and other assets covering the clinical testing of the NAV5001 to Alseres. Alseres will reimburse Navidea on a fully-documented, pass-through basis for any incurred maintenance costs of the contract manufacturer retroactive to March 1. In addition, as requested by Alseres, Navidea will supply clinical support services for NAV5001 on a cost-plus reimbursement basis. In consideration for the rights granted to Alseres, Navidea will receive a milestone payment in connection with NAV5001ís NDA approval by the FDA and a royalty on subsequent net sales of NAV5001.
April 22, 2015
08:02 EDTNAVBNavidea: Data for Menocept CD206 demonstrates potential to impact KS tumor cells
Navidea Biopharmaceuticals reported data at the American Association of Cancer Research Annual Meeting 2015 demonstrating that the Manocept molecule selectively binds to, and is continuously internalized by, tumor-associated macrophages and Kaposiís sarcoma, or KS, tumor cells in a preclinical model. Preliminary results from a clinical study also demonstrated that a single, subcutaneous injection of Technetium Tc 99m tilmanocept, an FDA-approved Manocept-based imaging agent, detects and localizes in KS tumors and the lymph nodes involved in draining the KS tumor fields. Collectively, the data demonstrate the potential for Manocept-based molecules to be used therapeutically to treat Kaposiís sarcoma. Manocept is designed to target CD206, which is expressed on TAMs and KS tissue. Modulation, including killing or modification of macrophage and KS expression profiles, represents a potential for a paradigm-shifting immunotherapeutic strategy.

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