The U.S FDA approved Camaps FX for use in pregnant women with type 1 diabetes. This first, hybrid, closed-loop app was developed by Camdiab Ltd., a spinout from Cambridge University, allows individuals aged two years and older with type 1 diabetes to manage their glucose levels.
Novo Nordisk A/S’s once-weekly human insulin analogue for adults with type 1 diabetes mellitus could be a useful tool for patients and physicians, the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee said May 24, but it also agreed that the risks outweighed the benefits for improving glycemic control.
Once-daily insulin treatment is getting a challenge from Novo Nordisk A/S’s once-weekly option. The U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee meets Friday, May 23, to review the BLA for once-weekly Awiqli (insulin icodec), a human insulin analogue from Novo for adults with type 1 diabetes mellitus.
Vertex Pharmaceuticals Inc. has tapped into Treefrog Therapeutics SA’s high-throughput stem cell manufacturing technology in a deal worth potentially up to $780 million to help it advance its type 1 diabetes programs, including phase I/II asset VX-880.
It has been previously demonstrated that insulin-reactive B cells act as antigen-presenting cells to promote type 1 diabetes by stimulating pathogenic T cells and leading to destruction of insulin-producing beta cells of pancreatic islets.
Creative Medical Technology Holdings Inc.'s Immcelz (CELZ-101) has been awarded orphan drug designation by the FDA. Immcelz is aimed at preventing allograft rejection in patients undergoing pancreatic islet cell transplantation.
It has been hypothesized that allogeneic, hypoimmune (HIP) iPSC-derived or donor-derived islet grafts could provide a new and safe therapeutic alternative for the treatment of type 1 diabetes mellitus (T1DM). Researchers from Sana Biotechnology Inc. and affiliated organizations have published preclinical data from studies further assessing this novel strategy in nonhuman primates (NHPs).
Kakao Healthcare Corp. launched an artificial intelligence (AI)-powered mobile application called PASTA on Feb. 1 for continuous glucose monitoring (CGM)-based diabetes care. PASTA pairs with two types of CGM sensors, either from Seoul-based I-sens Inc.’s Caresens Air or San Diego-based Dexcom Inc.’s G7 system.
A company focused on regulating immune response through nanoparticle technology, Cour Pharmaceuticals Development Co. Inc. has raised $105 million in a series A round to move its lead autoimmune disease products into phase IIa trials.
Encellin Inc. has announced the closing of a US$9.9 million financing round that will support the company’s development of its cell encapsulation platform with an initial focus on type 1 diabetes.