Navidea completes study of radiopharmaceutical NAV4694 Navidea Biopharmaceuticals announced the completion of a study of its novel radiopharmaceutical NAV4694 as a biomarker for visual detection and quantification of cerebral b-amyloid in diagnosing Alzheimer's disease, or AD. The study was designed and conducted by Navidea's partner, AstraZeneca, to assess the effects of various mass amounts of AZD4694, or NAV4694, on safety and the efficacy of Positron Emission Tomography scanning in subjects with AD and in healthy volunteers. 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.
Navidea 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.