Novo Nordisk announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Biologics License Application for its once-weekly basal insulin icodec, intended for the treatment of diabetes mellitus. This response highlights challenges related to the manufacturing process and concerns specific to the type 1 diabetes indication, delaying […]
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 […]
In a landmark announcement, Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and a subsidiary of Biocon Ltd, revealed its settlement and license agreement with Janssen Biotech Inc., and Johnson & Johnson. This agreement signifies a crucial step forward, granting Biocon Biologics the license to commercialize its Bmab 1200, a proposed biosimilar to […]