BioArctic AB’s partner Eisai has initiated the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (Leqembi) subcutaneous autoinjector for weekly maintenance dosing. This follows the Fast Track designation granted by the FDA. In the U.S., Leqembi is indicated for the treatment of Alzheimer’s disease in […]
Biogen Inc. (Nasdaq: BIIB), a leading pharmaceutical company, today announced a strategic reprioritization of its resources in Alzheimer’s disease (AD), a key therapeutic area expected to drive growth in both the near and long term. The company is set to continue advancing LEQEMBI (lecanemab-irmb), the first anti-amyloid beta treatment with FDA traditional approval in the […]
Quanterix, a biomarker detection firm powering scientific research and breakthrough diagnostics, has introduced LucentAD, a new test designed to aid in the evaluation of patients exhibiting cognitive symptoms indicative of early Alzheimer’s disease (AD). This test allows healthcare providers to quickly assess the likelihood of a patient exhibiting amyloid pathology, a significant marker of Alzheimer’s […]
Eisai and Biogen have secured the approval of the US Food and Drug Administration (FDA) for their jointly developed Leqembi (lecanemab-irmb) under the accelerated approval pathway for the treatment of Alzheimer’s disease. Leqembi is a 100 mg/mL injection for intravenous use, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and […]