Merck & Co., Inc. (known as MSD outside the United States and Canada) and Eisai Co., Ltd. have announced encouraging results from the first interim analysis of the Phase 3 LEAP-012 trial evaluating the efficacy of KEYTRUDA (pembrolizumab), an anti-PD-1 therapy by Merck, combined with LENVIMA (lenvatinib), an orally available multiple receptor tyrosine kinase inhibitor […]
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 […]
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 […]
Dr. Reddy’s Laboratories (Dr. Reddy’s Labs) has agreed to divest its rights to E7777, an engineered IL-2-diphtheria toxin fusion protein, and certain related assets to US-based Citius Pharmaceuticals in a deal worth up to $150 million. The Indian pharma company will get $40 million upfront upon the closing of the deal. It will be eligible […]
Glenmark Pharmaceuticals said that it has launched Rufinamide Tablets USP, 200 mg and 400 mg in the US, which is a therapeutic equivalent of Banzel Tablets, 200 mg and 400 mg owned by Eisai. Banzel is indicated for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS). The Indian pharma company said that it was […]
Jyseleca EC approval : Gilead Sciences and Galapagos have secured marketing authorization for Jyseleca (filgotinib 200 mg and 100 mg tablets) from the European Commission (EC) for the treatment of moderate to severe active rheumatoid arthritis (RA) in adults. The approval of the once-daily, oral, JAK1 inhibitor is rheumatoid arthritis patients who showed inadequate response […]
In a significant development for cancer treatment, Eisai and Merck have announced that the U.S. Food and Drug Administration (FDA) has approved Lenvima (lenvatinib) for the first-line treatment of hepatocellular carcinoma (HCC), the most common type of primary liver cancer in adults. This approval marks a pivotal advance, offering a new treatment option for patients […]