EISAI CO

Eisai and Biogen launch LEQEMBI in South Korea, a humanized anti-soluble aggregated amyloid-beta monoclonal antibody for mild cognitive impairment due to Alzheimer's disease or mild AD dementia. LEQEMBI selectively binds to soluble and insoluble Aβ aggregates, reducing both protofibrils and plaques in the brain, and is the first treatment shown to slow cognitive and functional decline.

EMA recommends Leqembi for early Alzheimer's patients without Apoe4 gene, reversing previous stance due to lower ARIA risk. UK's Nice deems it not cost-effective, while Eli Lilly's donanemab and Roche's trontinemab show promise.

The E-Learning module covers non-clear cell renal cancers' classification, incidence, prognosis, molecular alterations, and current management, emphasizing the need for subtype-specific clinical trials and biomarkers. It details treatments like mTOR and tyrosine kinase inhibitors, MET inhibitors, immune checkpoint inhibitors, and their combinations, highlighting the best response rates with these combinations and the logical approach of MET inhibition in MET-driven tumors.

Lexicon Pharmaceuticals, Inc. announced Ivan H. Cheung's election to its Board of Directors. Cheung, a biopharmaceutical executive with over 25 years of experience, currently serves as CEO of NextPoint Therapeutics and senior advisor to TPG Growth. His appointment coincides with Robert J. Lefkowitz's retirement after 23 years on the board.

Eisai launches Rozebalamin® for Injection 25 mg (mecobalamin) in Japan for slowing ALS progression, based on JETALS trial results. Mecobalamin, previously used for peripheral neuropathies, showed efficacy in early-stage ALS patients, addressing significant unmet medical needs.

AI-powered ECG tech and patient-centered solutions are revolutionizing clinical trials, enhancing cardiac safety, data integrity, and trial efficiency. This webcast explores how these innovations align with FDA guidance and improve clinical research practices.

The European Medicines Agency’s human medicines committee recommended Biogen and Eisai’s lecanemab for early Alzheimer’s disease, supported by the Clarity AD study showing a 31% reduction in clinical decline. The European Commission will now consider the CHMP’s recommendation.

The EMA's CHMP reversed its negative opinion on lecanemab, recommending approval for early-stage Alzheimer's disease. Based on the Clarity AD trial, lecanemab showed significant reductions in CDR-SB and amyloid PET centiloids, and improved cognitive scores. Despite approval in several countries, Australia's TGA declined registration due to safety concerns. Eisai is pursuing new dosing options, including a subcutaneous autoinjector.

New Alzheimer's therapies like Kisunla and Leqembi face regulatory and access challenges, highlighting the need for balancing clinical rigor with patient convenience. Decentralised trials (DCTs) are crucial for Alzheimer's research, though their use has declined, with Eli Lilly leading in DCT adoption. Digital health technologies, including telemedicine and wearables, offer potential to enhance trial data quality and patient recruitment, but challenges remain in ensuring technology usability and data integrity.

The European Commission has approved AbbVie’s Elahere for treating FRα-positive, platinum-resistant ovarian cancer, offering a 35% reduction in disease progression risk compared to standard chemotherapy. This marks the first new treatment in a decade for this condition in the EU, with potential revenue of $1.98bn by 2030.