The U.S. FDA granted Renalytix plc de novo marketing authorization for its prognostic test for chronic kidney disease (CKD). Kidneyintelx is an artificial intelligence-enabled prognostic testing platform to guide treatment decisions for adults with type 2 diabetes and diabetes-related early stage chronic kidney disease.
Two years after a U.S. FDA advisory committee agreed that Celltrans Inc.’s pancreatic islet cellular therapy had a favorable risk-benefit profile, the agency has finally approved Lantidra (donislecel) for treating adults with type 1 diabetes.
More evidence of big pharma’s interest in type 1 diabetes (T1D) arose as Eli Lilly and Co. disclosed its plan to buy encapsulated-cell-therapy collaborator Sigilon Therapeutics Inc., bringing aboard SIG-002, the early-stage drug on which the pair has been working since 2018. The news blasted upward shares of Cambridge, Mass.-based Sigilon (NASDAQ:SGTX), which closed June 29 at $21.15, up $17.24, or 441%.
Two companies presented highlights of studies that demonstrated outstanding results for novel devices at last weekend’s American Diabetes Association’s (ADA) 83rd Scientific Sessions, while Embecta Corp. and Senseonics Holdings Inc. provided updates that position them well for long-term performance. Glyconics Ltd. revealed a fingernail scanning device that simplifies screening for diabetes and Fractyl Health Inc. showed that its Revita procedure reduced blood glucose levels and promoted weight loss.
The recently concluded American Diabetes Association’s (ADA) 83rd Scientific Sessions continued to build powerful use cases for continuous glucose monitors in an ever-wider population and to highlight the value of automated insulin delivery (AID) systems that are getting ever-closer to duplicating the function of a natural pancreas. In addition to the news from Medtronic plc and Dexcom Inc. BioWorld covered earlier this week, Abbott Laboratories, Tandem Diabetes Care Inc. and Insulet Corp. also presented bright projections for future performance.
At the American Diabetes Association (ADA) Annual Meeting this weekend, Medtronic plc provided an update for investors and showcased results from its devices that all demonstrated better time in range for users. The Dublin-based company provided strong results with the U.S. FDA warning letter now behind it and the 780G Minimed pump and Guardian 4 sensor launches well underway.
New and updated clinical data presented by biopharma firms at the American Diabetes Association's 83rd Scientific Sessions, including: Biomea, Carmot, Eli Lilly, Inversago, Novo, Sernova, Vertex, Zealand.
As earlier-stage efforts in oncology continue with BMF-219, Biomea Fusion Inc. rolled out new clinical data June 23 from the first two cohorts of patients with type 2 diabetes enrolled in the phase II part of its ongoing phase I/II study called Covalent-111 testing the same compound, an oral covalent menin inhibitor.
Dexcom Inc. rolled out its plans for 2024 and 2025 at an Investor Day event held at the beginning of the American Diabetes Association Annual Meeting in its hometown of San Diego on June 23. The company is looking to expand from diabetes into metabolic health more broadly and previewed several new products designed to appeal to a wider market.
Sino Biopharmaceutical Ltd. formed a partnership with Gmax Biopharm International Ltd. to develop obesity candidate GMA-106. As part of the $57 million deal, Sino Biopharm acquired greater China rights to develop and commercialize the drug, in exchange for up-front and milestone payments to Gmax.
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