Itolerance Inc. and Kadimastem Ltd. have submitted a meeting request to the FDA's INTERACT committee for ITOL-102, which is under development as a potential cure for type 1 diabetes without the need for chronic immunosuppression.
Orsobio Inc., already in the clinic with three candidates, has completed its $60 million series A financing. The company, CEO Mani Subramanian told BioWorld, has taken its time to find the right programs, put them together and only raised capital when it saw the programs had legs. Even the series A is a measured step, as Subramanian called the financing “modest.”
A year-and-a-half after Eli Lilly and Co.’s Mounjaro (tirzepatide) gained U.S. FDA approval for adults with type 2 diabetes, the GLP-1 and GIP dual agonist was cleared for chronic weight management in adults who are obese or overweight and who also have one related condition.
Sibionics Technology Co. Ltd. said it received the CE mark for its continuous glucose monitoring (CGM) system, coined the Sibionics GS1 CGM, helping the company expand its market opportunities beyond China.
Zense-Life Inc. reported seeking patent protection for systems and processes for manufacturing working wires for a continuous biological sensor, that reduce cost and improve accuracy and efficiency compared to current technique.
Sab Biotherapeutics Inc. has obtained human research ethics committee (HREC) approval in Australia to commence a first-in-human phase I trial investigating SAB-142 for type 1 diabetes.
An artificial intelligence (AI) algorithm using voice technology developed by Klick Inc. could be a game changer for diagnosis of type 2 diabetes, helping to identify the 50% of individuals who unknowingly have the disease. The technology uses a six- to 10-second voice clip spoken into a smartphone plus basic health data to detect diabetes in close to nine out of 10 individuals, a study published in Mayo Clinic Proceedings: Digital Health found.
Novo Nordisk A/S’ semaglutide is making headlines again this week, with a phase IIIb testing the ubiquitous GLP-1 agonist on kidney outcomes halted early for efficacy. The independent data monitoring committee for the trial, dubbed Flow, concluded results from an interim analysis met prespecified efficacy criteria. Final data will read out in the first half of 2024.
Dexcom Inc. revealed new clinical data at the European Association for the Study of Diabetes (EASD) which highlighted the benefits of the use of continuous glucose monitoring (CGM). Results from the COMISAIR seven-year study, the longest prospective real-world CGM trial ever conducted, showed significant and continued reduction of HbA1c with the use of real-time CGM by people with type 1 diabetes.
Sab Biotherapeutics Inc. has announced a private placement of up to $130 to fund the company’s lead research program, SAB-142, a potential disease-modifying treatment for type 1 diabetes. SAB-142 is expected to advance into clinical trials in the fourth quarter of this year.
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