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Navidea Biopharmaceuticals Inc.
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Navidea Biopharmaceuticals Inc. announced that collaborators at Molecular Neuroimaging LLC (MNI) in New Haven, Conn., have enrolled the first subject in a clinical study to investigate the performance of [123I] NAV5001 in a single photon emission computed tomography (SPECT) imaging imaging procedure in connection with Navidea’s program to evaluate NAV5001 in Dementia with Lewy Bodies (DLB).
Navidea Biopharmaceuticals Inc. announced U.S. Food and Drug Administration (FDA) approval of Lymphoseek (technetium Tc 99m tilmanocept) 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 is a receptor targeted radiopharmaceutical designed to identify these lymph nodes, which have the highest probability of harboring cancer and thereby assist physicians in the staging of such patients.
Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced the completion of a study of its novel radiopharmaceutical NAV4694 as a biomarker for visual detection and quantification of cerebral ?-amyloid in diagnosing Alzheimer’s disease (AD). The study was designed and conducted by Navidea’s partner, AstraZeneca, to assess the effects of various mass amounts of AZD4694 (NAV4694) on safety and the efficacy of positron emission tomography (PET) scanning in subjects with AD and in healthy volunteers (HVs). Evaluations were completed on the effects of two mass doses of the radioligand on binding parameters and overall image quality. These endpoints are typical and important requirements of drug registration dossiers filed with regulatory authorities for approval of diagnostic agents.
August 7, 2012 — Navidea Biopharmaceuticals Inc., a company focused on precision diagnostic radiopharmaceuticals, announced it has entered into an agreement with Alseres Pharmaceuticals Inc. to license [123I]-E-IACFT Injection (CFT), an iodine-123 radio-labeled imaging agent being developed as an aid in the diagnosis of Parkinson’s disease and other movement disorders, with a potential use as a diagnostic aid in dementia.
July 24, 2012 — Navidea Biopharmaceuticals Inc., a specialty pharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced that clinical data from a head-to head study comparing its amyloid imaging candidate, AZD4694, to the benchmark amyloid imaging agent, 11C-PiB (PiB), was presented at the Alzheimer's Association International Conference (AAIC) in Vancouver, Canada by Professor Christopher Rowe, MD, FRACP, Director of the Department of Nuclear Medicine and Centre for PET at Austin Health, Melbourne, Australia.
June 13, 2012 — Navidea Biopharmaceuticals, Inc., a specialty pharmaceutical company focused on precision diagnostic radiopharmaceuticals, presented clinical data comparing its amyloid imaging candidate, AZD4694, to the benchmark amyloid imaging agent, 11C-PIB, at the Society of Nuclear Medicine Annual Meeting in Miami, Fla.