https://www.bioworld.com/rss en-us Corxel Pharmaceuticals Ltd.’s oral small-molecule GLP-1 receptor agonist, CX-11, met the primary endpoints in a phase II trial evaluating the candidate in obese and overweight patients in the U.S., according to top-line results. http://www.bioworld.com/articles/732349 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732349-corxel-vincentages-oral-glp-1-meets-phase-ii-obesity-endpoints Glass of water and tablets Corxel Pharmaceuticals Ltd.’s oral small-molecule GLP-1 receptor agonist, CX-11, met the primary endpoints in a phase II trial evaluating the candidate in obese and overweight patients in the U.S., according to top-line results. http://www.bioworld.com/articles/732050 Wed, 24 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732050-corxel-vincentages-oral-glp-1-meets-phase-ii-obesity-endpoints Glass of water and tablets Despite some back-and-forth with the U.S. FDA regarding inclusion in the somewhat controversial Commissioner’s National Priority Voucher (CNPV) program, Sanofi SA’s Tzield (teplizumab) gained FDA clearance, expanding use of the CD3-directed monoclonal antibody as a disease-modifying therapy for patients with recently diagnosed stage 3 type 1 diabetes (T1D). http://www.bioworld.com/articles/731874 Mon, 15 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731874-no-cnpv-needed-sanofis-tzield-gains-accelerated-nod-in-stage-3-t1d Vaccine vials and syringe Former principal officers of the American Diabetes Association (ADA) have hit back at the association’s board and CEO after it prohibited the distribution of an editorial published in its flagship journal Diabetes Care at the ADA’s meeting in New Orleans last Friday. Diabetes Care at the ADA’s meeting in New Orleans last Friday.]]> http://www.bioworld.com/articles/731872 Thu, 11 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/731872-researchers-hit-back-after-colleagues-removed-from-ada-meeting Hands holding paper Former principal officers of the American Diabetes Association (ADA) have hit back at the association’s board and CEO after it prohibited the distribution of an editorial published in its flagship journal Diabetes Care at the ADA’s meeting in New Orleans last Friday. Diabetes Care at the ADA’s meeting in New Orleans last Friday.]]> http://www.bioworld.com/articles/731723 Wed, 10 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731723-researchers-hit-back-after-colleagues-removed-from-ada-meeting Hands holding paper Dexcom Inc. and Insulet Corp. reported new clinical trial data on their diabetes technologies at the 2026 Scientific Sessions of the American Diabetes Association in New Orleans, offering insights that could aid in clinical adoption. Abbott Laboratories, meanwhile, highlighted the risks of diabetic ketoacidosis (DKA) and presented data showing the growing challenge of identifying DKA as it can develop quickly and mimic common illnesses. http://www.bioworld.com/articles/731707 Tue, 09 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731707-pumps-patches-and-fixes-at-the-ada Dexcom G7 CGM Dexcom Inc.’s G7 continuous glucose monitoring system. Abbott Laboratories received CE mark approval for two dual glucose and ketone sensing systems, bringing to the market sensors that could be transformational to the lives of people with diabetes at risk of diabetic ketoacidosis. http://www.bioworld.com/articles/731441 Thu, 28 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731441-abbott-receives-ce-mark-for-dual-glucose-ketone-sensing-systems Abbott Libre Duo sensor on patient  Libre Duo sensor. Credit: Abbott Laboratories Insulet Corp. has initiated a voluntary medical device correction affecting insulin pump pods in its Omnipod product lines after discovering a manufacturing issue that could lead to the leaking of insulin and the under-delivery of doses in some patients. The company said that some pods from specific lots may have a small tear in the cannula. http://www.bioworld.com/articles/731419 Wed, 27 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731419-insulet-initiates-voluntary-correction-on-omnipod-devices Omnipod 5 Omnipod 5. Credit: Insulet Corp. Reports that Sanofi SA has asked to withdraw its sBLA for Tzield (teplizumab) from the U.S. FDA’s Commissioner’s National Priority Voucher (CNPV) program is once again raising questions about whether leadership skepticism is overruling approval decisions at the agency. http://www.bioworld.com/articles/730970 Thu, 07 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/730970-fda-slowdown-on-tzield-sbla-underlines-cnpv-questions FDA logo on textured paper Credit: Araki Illustrations - stock.adobe.com Wall Street met with satisfaction but not surprise Eli Lilly and Co.’s undeniably positive top-line results from the phase III Achieve-4 study testing the efficacy and safety of Foundayo (orforglipron) compared to insulin glargine in adults with type 2 diabetes and obesity or overweight at increased cardiovascular risk. http://www.bioworld.com/articles/730389 Thu, 16 Apr 2026 12:00:00 -0400 https://www.bioworld.com/articles/730389-lillys-glp-1-foundayo-aces-mace-in-dili-of-a-phase-iii Foundayo Credit: Eli Lilly and Co. Introduced last year as a pilot program, the U.S. FDA Commissioner’s National Priority Voucher (CNPV) could be here to stay – at least for the duration of Marty Makary’s tenure as FDA commissioner. Since the FDA unveiled the CNPV last June, it has welcomed 18 products from 16 companies into the “game-changer” program for patients, as Makary described it. The goal is to provide an “ultrafast review pathway,” one to two months instead of the standard 10 to 12 months, for drugs and biologics of strategic national importance while maintaining the FDA’s scientific and regulatory standards, according to the agency. http://www.bioworld.com/articles/729950 Mon, 30 Mar 2026 12:00:00 -0400 https://www.bioworld.com/articles/729950-us-fda-pondering-next-steps-for-cnpv Paper airplanes with red leading Medtronic plc has lowered its fiscal year 2026 earnings per share (EPS) guidance by 12 cents on the back of factors relating to its diabetes subsidiary, Minimed Group Inc., which recently completed its IPO. http://www.bioworld.com/articles/729905 Thu, 26 Mar 2026 12:00:00 -0400 https://www.bioworld.com/articles/729905-medtronic-cuts-earnings-guidance-on-minimed-factors Scissors cutting stack of $100 bills Minimed Group Inc. secured U.S. FDA approval for Minimed Flex, its next-generation discreet, smartphone-controlled insulin pump. The nod from the FDA follows the company’s debut on Nasdaq March 6. About half the size of the Minimed 780G pump and roughly the size of two stacked insulin vials, the screenless pump was designed in collaboration with people living with diabetes to offer a more intuitive, lifestyle‑friendly way to manage the condition. http://www.bioworld.com/articles/729746 Thu, 19 Mar 2026 12:00:00 -0400 https://www.bioworld.com/articles/729746-minimed-secures-fda-nod-for-next-gen-insulin-pump Minimed Flex system Minimed Flex system. Credit: Minimed Group Inc. In a sea of uncertainty, a large-scale, long-term Swedish study is the first to show that people using GLP-1 receptor agonists are less likely to have worsening mental illness. The study involved a national cohort of 95,490 people diagnosed with depression or anxiety disorder, who also were treated with any diabetes drug (apart from insulin). http://www.bioworld.com/articles/729743 Thu, 19 Mar 2026 12:00:00 -0400 https://www.bioworld.com/articles/729743-study-glp-1ras-associated-with-less-risk-of-mental-illness-getting-worse Mental illness art concept Further weight loss details are yet to come this year, but Eli Lilly and Co. scored positive top-line results in Transcend-T2D-1, a phase III trial evaluating the efficacy and safety of retatrutide, an investigational first-in-class GIP, GLP-1 and glucagon triple hormone receptor agonist, as an adjunct to diet and exercise in type 2 diabetes (T2D). http://www.bioworld.com/articles/729742 Thu, 19 Mar 2026 12:00:00 -0400 https://www.bioworld.com/articles/729742-triple-crown-t2d-purse-for-lillys-phase-iii-retatrutide Hand weight, sneakers, scale, measuring tape, apple, injector and glucose monitor Pricing shares at $20 each, below the intended price range, insulin delivery company Minimed Group Inc. debuted with an IPO on Nasdaq March 6, raising $560 million. The company offered a total of 28 million shares, which would have brought the Northridge, Calif.-based company $742 million in gross proceeds if the IPO had priced at the midpoint of the $25-to-$28 price range disclosed in February. http://www.bioworld.com/articles/729356 Fri, 06 Mar 2026 12:00:00 -0500 https://www.bioworld.com/articles/729356-minimed-ipo-raises-560m-as-it-splits-from-medtronic Businessman and IPO virtual screen Eli Lilly and Co. got a breather when the U.S. Ninth Circuit Court of Appeals agreed that the company doesn’t owe Research Corporation Technologies Inc. (RCT) royalties on its diabetes drugs under a licensing agreement Lilly had made with Phillips Petroleum Co. in 1990 and that Phillips later sold to RCT. http://www.bioworld.com/articles/729246 Thu, 26 Feb 2026 12:00:00 -0500 https://www.bioworld.com/articles/729246-ninth-circuit-agrees-with-lilly-in-royalty-dispute Coming off a U.S. FDA approval of the first GLP-1 in pill format, Novo Nordisk A/S leaned further into oral drug delivery efforts, partnering with Vivtex Corp. to develop next-generation oral formulations of peptide and protein therapeutics in a potential $2.1 billion deal that marks the highest-profile news for Vivtex since the firm spun out of MIT in 2018. http://www.bioworld.com/articles/729200 Wed, 25 Feb 2026 12:00:00 -0500 https://www.bioworld.com/articles/729200-vivtexs-oral-drug-delivery-approach-draws-novo-in-21b-deal GI-ORIS-pic-Vivtex-2-25.jpg GI-ORIS, or “GI tract on a chip” screening system. Credit: Vivtex Corp. Minimed Group Inc., Medtronic plc’s diabetes business, is looking to raise up to $784 million in its IPO. Medronic last May revealed plans to spin off the unit as an independent public company and expected to complete the separation within 18 months. http://www.bioworld.com/articles/729196 Tue, 24 Feb 2026 12:00:00 -0500 https://www.bioworld.com/articles/729196-medtronics-diabetes-unit-minimed-seeks-784m-in-ipo IPO, coins, financial chart Viking Therapeutics Inc. said after-market hours Feb. 11 that it plans to advance its oral dual GLP-1/GIP receptor, VK-2735, into a phase III trial for obesity in the third quarter of 2026. VK-2735 is a novel dual glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide (GLP-1/GIP) receptor agonist. http://www.bioworld.com/articles/728847 Thu, 12 Feb 2026 12:00:00 -0500 https://www.bioworld.com/articles/728847-viking-to-push-oral-glp-1-gip-drug-into-phase-iii-obesity-trial Pills and bottle Sava Technologies Ltd. reported positive clinical data showing that its multi-molecule biosensor technology can reliably monitor glucose levels beneath the skin in real time. http://www.bioworld.com/articles/728718 Tue, 10 Feb 2026 12:00:00 -0500 https://www.bioworld.com/articles/728718-sava-sees-positive-data-on-microsensing-tech Sava Technologies' multi-molecule biosensor technology Sava's multi-molecule biosensor technology. Credit: Sava Technologies Ltd. Sciwind Biosciences Co. Ltd. said Jan. 30 it won Chinese approval for self-developed glucagon-like peptide-1 (GLP-1) receptor agonist, ecnoglutide (Xianyida), to treat adults with type 2 diabetes. http://www.bioworld.com/articles/728623 Tue, 03 Feb 2026 12:00:00 -0500 https://www.bioworld.com/articles/728623-china-nmpa-approves-sciwinds-glp-1-injection-for-diabetes Medtronic plc is continuing to put its money where its mouth is as it plans to exercise its option to acquire Cathworks Ltd. for up to $585 million. The company said last month it was committed to expanding its pipeline through strategic investments and targeted acquisitions. The move for Cathworks comes on the heels of Medtronic’s $90 million investment in Anteris Technologies Global Corp. http://www.bioworld.com/articles/728546 Tue, 03 Feb 2026 12:00:00 -0500 https://www.bioworld.com/articles/728546-medtronic-to-acquire-cathworks-for-585m Cathworks Ffrangio system Cathworks' Ffrangio system is an AI guidance system for coronary artery disease management. Credit: Cathworks Ltd. Sciwind Biosciences Co. Ltd. said Jan. 30 it won Chinese approval for self-developed glucagon-like peptide-1 (GLP-1) receptor agonist, ecnoglutide (Xianyida), to treat adults with type 2 diabetes. http://www.bioworld.com/articles/728531 Mon, 02 Feb 2026 12:00:00 -0500 https://www.bioworld.com/articles/728531-china-nmpa-approves-sciwinds-glp-1-injection-for-diabetes Six-month results from the REMAIN-1 trial showed that Fractyl Health Inc.’s Revita procedure cut post-GLP-1 weight regain by about 70% compared with a sham procedure in patients who discontinued incretin-based drugs such as semaglutide and tirzepatide after achieving substantial weight loss. http://www.bioworld.com/articles/728273 Thu, 29 Jan 2026 11:00:00 -0500 https://www.bioworld.com/articles/728273-fractyls-revita-reduces-post-glp-1-weight-regain-70 Illustration of Revita DMR in intestine Revita duodenal mucosal resurfacing system. Credit: Fractyl Laboratories Inc. Beta Bionics Inc.’s preliminary results for its first full year as a public company offered an early read on developments and market positioning in the insulin pump and patch market, with analysts pointing to steady growth, rising pharmacy channel penetration and intensifying pressure as more products target both type 1 and type 2 diabetes. http://www.bioworld.com/articles/728253 Tue, 27 Jan 2026 11:00:00 -0500 https://www.bioworld.com/articles/728253-beta-bionics-posts-strong-results-in-inaugural-public-company-year Ilet2.jpg Beta Bionics Inc.’s Ilet automatic insulin delivery system Abbott Laboratories reported fourth quarter sales below expectations before the market opened on Jan. 22, sending the stock down nearly 12% from the prior day's closing. The biggest hits came from contraction in the nutrition group along with continued disruption in the diagnostics unit from volume-based procurement in China. Medical devices suffered from market share loss in electrophysiology and slower than expected uptake of continuous glucose monitors. The pharma group performed as anticipated, posting 7% growth. http://www.bioworld.com/articles/728077 Thu, 22 Jan 2026 11:00:00 -0500 https://www.bioworld.com/articles/728077-abbott-misses-q4-expectations Abbott sign Credit: Abbott Laboratories Investors poured a further $13 million into Vicentra BV for Kaleido, its insulin patch pump system, taking the total raised in the company’s series D financing round to $98 million. The funds come amid significant changes across diabetes technology, particularly the acceleration of patch pumps. Kaleido is one of the smallest, lightest, and most precise insulin patch pumps available. http://www.bioworld.com/articles/727605 Fri, 09 Jan 2026 11:00:00 -0500 https://www.bioworld.com/articles/727605-vicentra-secures-additional-13m-for-kaleido-insulin-patch-pump Kaleido user Kaleido insulin patch pump system. Credit: Vincentra Over the last year, diabetes technology saw significant changes, including the acceleration of patch pumps, ever-smaller continuous glucose monitors (CGM), implanted CGMs and increased interest in devices that measure additional chemicals in blood without needles. http://www.bioworld.com/articles/727565 Mon, 05 Jan 2026 11:00:00 -0500 https://www.bioworld.com/articles/727565-positive-changes-ahead-for-diabetes-in-2026 Art concept for metabolism The first international consensus framework for the use of continuous ketone monitoring in people with diabetes, published in The Lancet Diabetes & Endocrinology, calls development and use of ketone sensors for the prevention of diabetic ketoacidosis “transformational.” Several companies in the diabetes technology market have recently reported that they are developing dual glucose-ketone sensors, though none have gained U.S. FDA approval yet. http://www.bioworld.com/articles/726752 Thu, 11 Dec 2025 11:00:00 -0500 https://www.bioworld.com/articles/726752-international-consensus-on-ketone-monitoring-emerges Scientists shaking hands in the lab