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.
China’s National Medical Products Administration gave the nod to Innovent Biologics Inc.’s picankibart (IBI-112), branded as Pecondle, for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Allogeneic CAR T-cell therapy offers several advantages over an individualized autologous CAR T approach, thanks to the use of readily available, higher quality and quantity of starting donor T cells and the potential to generate multiple doses from a single manufacturing process.
2025 has been the most challenging year in the efforts to fight HIV since at least the advent of antiretroviral therapy. In a report on “Overcoming disruption, transforming the AIDS response,” released last week ahead of World AIDS Day on Dec. 1, the Joint United Nations Program on HIV/AIDS (UNAIDS) described “a global system in shock” by sharply reduced funding from the U.S. and other wealthy nations. Scientifically, for now, progress is ongoing. To mark World AIDS Day, Nature published three independent studies on HIV.
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.
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