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.
Following the receipt of a U.K. Conformity Assessed (UKCA) mark for its kidney function diagnostic software, the CKD Screening Prioritizer (CSP), Gendius Ltd. is hoping to soon receive CE mark and then U.S. FDA approval next year. Given that people with type 2 diabetes are at a higher risk of developing chronic kidney disease, Gendius’ pre-screening software will be “transformative” for patients and health care systems, CEO Rory Cameron told BioWorld in an interview.
The FDA has cleared IND applications for UBT-251 injection, a long-acting triple-targeted glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP)/glucagon receptor agonist developed by The United Bio-Technology (Hengqin) Co. Ltd., a wholly owned subsidiary of The United Laboratories International Holdings Ltd., for adult type 2 diabetes and for overweight or obese subjects.
In another boost to its diabetes portfolio, Medtronic plc was granted CE mark approval for its Simplera continuous glucose monitor (CGM) sensor. The EU greenlight for Simplera follows the U.S. FDA approval for Medronic’s Minimed 780G insulin pump system earlier in the year. Simplera is an all-in-one disposable CGM sensor which features a two-step insertion process and will help patients who must have multiple daily injections (MDI) manage their diabetes.
Safety concerns overrode benefit when the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted unanimously, 19-0, Sept. 21 that the potential risks of Intarcia Therapeutics’ ITCA-650 outweighed the compliance and A1C-lowering benefits the twice-yearly implantable exenatide-device combination product could provide for adults with type 2 diabetes.
Aiming to provide additional utility and information to its continuous glucose monitors (CGMs), Dexcom Inc. is tying in the nutrition information provided by Rxfood Corp.’s app for customers in Canada. Clinics, hospitals, pharmacies, health plans, employers and others can make the app available to the beneficiaries and patients who use the Dexcom G6 or G7 systems, once the program is rolled out.
A Sept. 21 U.S. FDA advisory committee meeting will either be a “Hail Mary” or a last gasp of life for ITCA-650, a twice-yearly implantable exenatide-device combination product intended to improve glycemic control in adults with type 2 diabetes.
Medwatch Technologies Inc. reported a patent for the use of near infrared (NIR) spectroscopy, from collection of NIR LEDs surrounding a photo diode sensitive to wavelengths in the range 400 nm to 1650 nm, to noninvasively detect blood glucose concentrations, in a multi-sensing wearable device such as a watch or patch.
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