Signos Inc. landed U.S. FDA clearance for its over-the-counter glucose monitoring system, which combines Dexcom Inc.'s non-prescription Stelo continuous glucose monitor with an AI-powered platform focused on weight management and metabolism. The sensor transmits glucose readings to a smartphone app that interprets the data, provides guidance for healthy habits and educates the user.
Medtronic plc posted nearly 50% year-over-year growth in its cardiac ablation business this quarter, with a 72% increase in revenue in the U.S., largely driven by pulsed field ablation. With significant opportunity in renal denervation and a new committee to look at growth including M&A and divestitures and another to review operations, analysts think the company stands a good chance of shedding its “chronic underperformer” image.
Several cardiology societies in the U.S. have updated their guidelines for management of hypertension, which for the first time includes and endorsement of renal denervation (RDN). Two companies are poised to benefit from the news, including Medtronic plc with its Symplicity Spyral device and Recor Medical Inc., and its Paradise RDN system.
Doing his version of the Texas Two-Step, Texas Attorney General (AG) Ken Paxton is again shuffling Eli Lilly and Co. into a state courtroom – this time for allegedly overstepping the anti-kickback line.
A federal appeals court opened the door Aug. 6 for an amended class-action lawsuit alleging that Astrazeneca plc, Eli Lilly and Co., Novo Nordisk A/S and Sanofi SA engaged in a horizontal price-fixing conspiracy involving insulin products and GLP-1 drugs indicated in diabetes when they each adopted similar policies in 2020 to impose restrictions on 340B discounts to an unlimited number of contract pharmacies.
Sava Technologies Ltd. raised $19 million in a series A funding round for its multi-molecule biosensor platform that can detect biomarkers just beneath the skin, in real-time. The funds will go towards its first product, a continuous glucose monitor, which early clinical data showed can generate accurate glucose readings for up to 10 days of continuous wear.
With reduced sales and operating expectations for the rest of the year, Novo Nordisk A/S is on the receiving end of a huge stock drop. For a big pharma, where the stock drops are usually more modest, the shares (NASDAQ:NVO) fell off a cliff on July 29, closing 21.8% downward to $53.93 each, the lowest price per share in the past 12 months. Lower U.S. sales of semaglutide blockbusters Wegovy and Ozempic for treating obesity and diabetes are at the heart of the plunge. In May, the Danish company had expected 13% to 21% sales growth but now is looking at only 8% to 14%.
The U.S. FDA on July 15 cleared Biocon Biologics Ltd.’s Kirsty (insulin aspart-xjhz) as the first and only interchangeable biosimilar product referencing Novo Nordisk A/S’ Novolog (insulin aspart), a rapid-acting diabetes medication.
Directsens GmbH recently signed a collaboration agreement with Metage, an Austrian research consortium, to advance a test for the early detection of type 2 diabetes. The focus of the partnership will be on validating Directsens’ Xpressgt assay, which measures 2-hydroxybutyrate levels in venous blood, and could be used by clinicians to inform patients they are at risk of developing type 2 diabetes.
The U.S. FDA on July 15 cleared Biocon Biologics Ltd.’s Kirsty (insulin aspart-xjhz) as the first and only interchangeable biosimilar product referencing Novo Nordisk A/S’ Novolog (insulin aspart), a rapid-acting diabetes medication.
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