News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
Eisai has submitted marketing authorization applications for lecanemab in Europe and Japan as it builds up its global plans for the Alzheimer’s drug, which was approved in the US earlier this month.
Versanis Bio is taking bimagrumab into a Phase 2b study across the US, Australia and New Zealand.
The European Medicines Agency (EMA) is planning to alert healthcare professions about liver failure cases linked to Zolgensma, a gene therapy against spinal muscular atrophy (SMA), which is developed by Novartis.
Lumen Bioscience has been highlighting recent progress made on its clinical and regulatory journey while also announcing several funding milestones supporting the development of its therapeutics to prevent serious diarrheal diseases.