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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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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 23, 2015
13:16 EDTCAHPharmacies, PBMs seen as potential buyers after Omnicare said to explore sale
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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.
April 20, 2015
11:32 EDTCAHCardinal Health to pay $26.8M to settle FTC charges
In its latest action to ensure competition in the nationís healthcare markets, the FTC announced that Cardinal Health has agreed to resolve charges that it illegally monopolized 25 local markets for the sale and distribution of low-energy radiopharmaceuticals and forced hospitals and clinics to pay inflated prices for these drugs. The proposed stipulated order requires Cardinal to pay $26.8M of ill-gotten gains and represents the second largest monetary settlement the FTC has obtained in an antitrust case. The money will be deposited into a fund for distribution to injured customers. The order also includes provisions to prevent future violations and restore competition in six markets where Cardinal remains the dominant radiopharmacy. Reference Link
April 16, 2015
07:05 EDTCAHNovaBay signs distribution agremeent with AmerisourceBergen
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April 15, 2015
10:36 EDTCAHBofA/Merrill U.S. credit analysts hold an analyst/industry conference call
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April 13, 2015
14:07 EDTCAHEarnings Watch: Johnson & Johnson shares down slightly since last earnings
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