The priority BLA from Otsuka Pharmaceutical Co. Ltd., of Tokyo, and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization Inc., for sibeprenlimab to treat immunoglobulin A nephropathy (IgAN) has received accelerated approved by the U.S. FDA.
Insilico Medicine IP Ltd. has divulged serine/threonine-protein salt-inducible kinase (SIK) inhibitors reported to be useful for the treatment of autoimmune disease, cancer, metabolic diseases, transplant rejection, and cardiovascular, dermatological, inflammatory and respiratory disorders, among others.
Novo Nordisk A/S’ wild card bet that its GLP-1 receptor agonist semaglutide could be used to treat Alzheimer’s disease has not paid off, with the company reporting two phase III trials have shown no effect on slowing disease progression.
Nimbus Salacia Inc. has disclosed serine/threonine-protein kinase SIK2 (QIK) inhibitors reported to be useful for the treatment of autoimmune diseases, cancer, diabetes, inflammatory bowel disease, osteoarthritis, osteoporosis, rheumatoid arthritis and skin hyperpigmentation, among others.
A disrupted balance between T-effector and T-regulatory cells, together with the activation of autoreactive or alloreactive B cells that generate pathogenic antibodies, is a defining feature of autoimmune diseases and transplant rejection and contributes to their often poor outcomes.
Invivyd Inc. has nominated VBY-329 as a preclinical development candidate for the prevention of respiratory syncytial virus (RSV) among neonates, infants and children.
Contineum Therapeutics Inc.’s midstage study of its multiple sclerosis drug, PIPE-307, missed its primary and secondary endpoints, dropping the stock on Nov. 21. Top-line phase II results from the Vista study of the M1 receptor agonist PIPE-307 for treating relapsing-remitting multiple sclerosis saw no significant changes in binocular 2.5% low contrast letter acuity in the treatment arms, a key efficacy measure.
Evaxion A/S is advancing its cytomegalovirus (CMV) vaccine program, EVX-V1, with new data demonstrating protective effects of lead antigens in the program. EVX-V1 is a next-generation, multicomponent vaccine program combining novel AI-discovered antigens with AI-optimized versions of established CMV vaccine antigens.
Antengene Corp. Ltd. has outlined progress in its early-stage pipeline. The company has leveraged its Antengager T-cell engager (TCE) platform for the discovery of multiple investigational programs.
Harbour Biomed is stepping up its antibody discovery process by using AI to develop innovative therapeutics. “We have done great through the traditional way of generating leads and designing molecules, but there’s a major gap as some therapeutics cannot reach the desired location or common targets,” Harbour Biomed founder, chairman and CEO Jingsong Wang told BioWorld.
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