SURMOUNT-1 results show a 94% reduction in risk of progression to type 2 diabetes across all pooled doses of tirzepatide compared to placebo over three years Results suggest one new case of diabetes could be prevented for every nine patients treated with tirzepatide Participants treated with tirzepatide had an average weight reduction of 22.9% (15 mg dose) INDIANAPOLIS, Nov. 13, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE:...Read more
Prioritize clinical and preclinical development on type 1 diabetes (UP421 and SC451), B-cell mediated autoimmune diseases (SC291), refractory B-cell malignancies (SC262), and the fusogen platform for generating in vivo CAR T cells Modified strategy extends expected cash runway into 2026 with potential for multiple data readouts in 2024 and 2025 SEATTLE, Nov. 04, 2024 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a...Read more
First two out of three subjects treated with tegoprubart as part of immunosuppression regimen to prevent transplant rejection achieved insulin independence and remain insulin free, with glucose control in the normal range; Third subject was recently transplanted and is on trajectory for insulin independence Islet engraftment in the first two subjects with tegoprubart estimated three to five times higher than engraftment in three...Read more
Wegovy® recommended by the European regulatory authorities for label update to reflect reduced heart failure symptoms and improved physical function Wegovy® (semaglutide 2.4 mg) is the first obesity medication to receive a positive opinion recommending a label update that reflects reduced symptoms and improved physical limitations and exercise function in people with obesity-related heart failure with preserved ejection...Read more
Eversense 365 cleared in the U.S. as an integrated continuous glucose monitoring (iCGM) system for people with diabetes With a single sensor, the Eversense 365 system provides one year of use, versus 10-14 days with short-term CGM’s for minimal life disruption Launch expected early in the fourth quarter of 2024 GERMANTOWN, Md. and PARSIPPANY, N.J., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Senseonics Holdings, Inc. (NYSE American:...Read more
Detailed results were published in The Lancet and simultaneously presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2024 INDIANAPOLIS, Sept. 10, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results from the QWINT-5 phase 3 trial evaluating once-weekly insulin efsitora alfa (efsitora) compared to once-daily insulin degludec in adults with type 1 diabetes who...Read more
In QWINT-2, efsitora helped adults naïve to insulin therapy currently using and not using GLP-1 receptor agonists achieve an A1C below 7% Detailed results were published in The New England Journal of Medicine and simultaneously presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2024 INDIANAPOLIS, Sept. 10, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results...Read more
New Research Confirms the Benefit of Dario's Integrated, Data-Driven Approach to Health and Chronic Condition Management NEW YORK, Sept. 10, 2024 /PRNewswire/ -- DarioHealth Corp. (Nasdaq: DRIO) ("Dario" or the "Company"), a leader in the global digital health market announced today the publication of a new study in the peer-reviewed journal Frontiers in Endocrinology. The study demonstrates the effectiveness of Dario's...Read more
Study results aligned with positive clinical trial outcomes for type 1 diabetes treatment with sotagliflozin TIR measures approach target set by American Diabetes Association Data to be presented at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain and online THE WOODLANDS, Texas, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today...Read more
In the phase 3 study, QWINT-1, efsitora was administered via four fixed doses once weekly in a single-use autoinjector in people with type 2 diabetes using basal insulin for the first time In a second phase 3 study, QWINT-3, efsitora also delivered non-inferior A1C reduction compared to daily insulin in people with type 2 diabetes switching from daily basal injections INDIANAPOLIS, Sept. 5, 2024 /PRNewswire/ -- Eli Lilly and Company...Read more
Intends to Create Two Distinct Businesses, Re-Focusing Genprex on its Oncology Clinical Development Program New Subsidiary to Focus on Developing Novel Gene Therapy for Diabetes AUSTIN, Texas, Sept. 4, 2024 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced its intention...Read more
Results showed reductions in heart attack, stroke and heart failure events in all patients with even greater benefit for heart failure events among patients with longer diabetes duration New analysis further differentiates INPEFA among SGLT inhibitors THE WOODLANDS, Texas, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that a post-hoc analysis of Phase 3 data from the SCORED clinical...Read more
While 9 out of 10 people with diabetes are living with T2D, many of the automated insulin delivery solutions currently on the market were designed for people living with T1D. 300-unit insulin reservoir is more suitable for people with T2D who are interested in moving from multiple daily injections (MDI) to pump therapy, based on an average daily dose of 95.9 units of insulin.1 PARSIPPANY, N.J., Sept. 03, 2024 (GLOBE NEWSWIRE) --...Read more
Label expansion makes Omnipod 5 commercially available to 6 million people living with insulin-requiring type 2 diabetes Omnipod 5 is the first and only automated insulin delivery (AID) system indicated for both type 1 and type 2 diabetes ACTON, Mass. / Aug 26, 2024 / Business Wire / Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products,...Read more
Available for purchase today at Stelo.com for people in the U.S. 18 and older not using insulin Provides 24/7 powerful and personalized glucose insights directly to a smartphone,* revealing how food, exercise and sleep can affect glucose Tracking glucose just got easier, with no prescription and no fingersticks, ever Specifically designed to help people with Type 2 diabetes not using insulin and those with prediabetes reach their A1c...Read more
DehydraTECH-liraglutide is showing apparent superiority to DehydraTECH-semaglutide Select DehydraTECH-CBD formulations are showing apparent superiority to DehydraTECH-GLP-1 at 4 and 8 weeks KELOWNA, BC / ACCESSWIRE / August 21, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX) & (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that it has received 4-week and 8-week blood...Read more
The global obesity-diabetes drugs market is projected to be worth around $100 billion by 2034[1] – largely driven by Glucagon-like peptide-1 (GLP-1) inhibitors like Novo Nordisk's Ozempic® and Wegovy® and Eli Lilly's Trulicity® and Mounjaro® and sodium glucose cotransporter-2 (SGLT2) inhibitors such as Boehringer Ingelheim's Jardiance® Positive results from multiple in vivo studies show the impact of sphingosine kinase-2 (SPHK2)...Read more
Medtronic Diabetes expands CGM offerings to meet more people where they are in their diabetes journey DUBLIN, Aug. 7, 2024 /CNW/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced the U.S. Food and Drug Administration (FDA) approval for its Simplera™ continuous glucose monitor (CGM) — the company's first disposable, all-in-one CGM that's half the size of previous Medtronic CGMs. The discreet...Read more
Unique partnership with Medtronic will enable continuous glucose monitoring (CGM) sensors based on Abbott's FreeStyle Libre sensing technology to integrate with Medtronic's insulin delivery systems Abbott now has partnerships with four of the largest companies that develop automated insulin delivery systems – offering more choices to people around the world to benefit from connectivity with Libre technology ABBOTT PARK, Ill.,...Read more
Only Automated Insulin Delivery System in Canada to Feature Both Dexcom G7 and G6 CGM Technology Now Authorized for Sale by Health Canada MARKHAM, Ontario / Jul 29, 2024 / Business Wire / Tandem Diabetes Care, Inc. (Nasdaq: TNDM) and Dexcom, Inc. (Nasdaq: DXCM) today announced the updated t:slim X2™ insulin pump software is compatible with both Dexcom G7 and Dexcom G6 Continuous Glucose Monitoring (CGM) Systems and is authorized...Read more
Two-year Phase III data presented at ASRS 2024 show Susvimo’s potential as an alternative to eye injections to treat diabetic macular edema (DME) and diabetic retinopathy (DR) Safety data were consistent with the known safety profile for Susvimo in people with DME and DR Additionally, the FDA has accepted the filing application for Susvimo in DME and DR based on one-year Pagoda and Pavilion study data Susvimo is a...Read more
More than 90% of patients had absence of DME after four years in a pre-specified exploratory endpoint People treated with Vabysmo sustained vision gains and anatomical improvements, with almost 80% receiving treatment at intervals of three or four months, in an exploratory analysis The study met all primary endpoints, showing safety data were consistent with Vabysmo’s known safety profile This is the largest long-term extension...Read more
July 16, 2024 - Biodexa Pharmaceuticals PLC (“Biodexa” or “the Company”), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs announces progress on initiation of a Phase 2a study of tolimidone in Type 1 diabetes (“T1D”). Health Canada has approved a Phase 2a dose confirmation study of tolimidone in T1D. The study will be an...Read more
Bagsværd, Denmark, 10 July 2024 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) covering the Biologics License Application for once-weekly basal insulin icodec for the treatment of diabetes mellitus. In the letter, the FDA has requests related to the manufacturing process and the type 1 diabetes indication before the review of the application can be completed....Read more
Cadisegliatin is a potential first-in-class oral liver selective glucokinase activator for T1D, which has been granted Breakthrough Therapy designation by the FDA for T1D Cadisegliatin has been dosed in over 500 subjects to date, including 300 patients with diabetes HIGH POINT, N.C., June 24, 2024 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late stage biopharmaceutical company with an innovative clinical portfolio of...Read more
Company's Receptor Co-Agonists Demonstrate Potent Body Weight Reductions, Decreased Food Intake and Improved Metabolic Profile in Healthy Rats and Diet-Induced Obese Mice SAN DIEGO, June 24, 2024 /PRNewswire/ -- Viking Therapeutics, Inc. (Viking) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced the presentation of...Read more
Ziftomenib induces insulin production, improves insulin sensitivity and reduces insulin resistance in preclinical model of type 2 diabetes Kura advancing multiple, next-generation menin inhibitor drug candidates targeting diabetes and other metabolic diseases SAN DIEGO, June 24, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision...Read more
Generic Victoza® is the first-ever generic GLP-1 and supports increased demand for this category of therapies in the U.S. market. This launch adds to Teva’s continued commitment to its complex generic medicine portfolio. Liraglutide injection is indicated to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus and reduce the risk of cardiovascular events in adults with type 2...Read more
SAN DIEGO / Jun 22, 2024 / Business Wire / Tandem Diabetes Care, Inc. (Nasdaq: TNDM), a leading insulin delivery and diabetes technology company, today presented new real-world insights from a survey on Tandem Mobi user satisfaction and wearability during the 84th Scientific Sessions of the American Diabetes Association (ADA) taking place in Orlando, Florida. The survey found that 86 percent of participants were satisfied or very satisfied...Read more
Largest, longest, and most racially diverse study of automated insulin delivery (AID) conducted in people with type 2 diabetes to date ACTON, Mass. / Jun 21, 2024 / Business Wire / Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today shared positive results from its Omnipod 5 Automated Insulin Delivery System (Omnipod 5) type 2...Read more
With its advanced algorithm that provides autocorrections every 5 minutes, the latest data demonstrated that the MiniMed™ 780G system decreased rates of early morning hyperglycemia, known as dawn phenomenon, and improved overnight sleep DUBLIN and ORLANDO, Fla., June 21, 2024 /CNW/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, is presenting a comprehensive body of new data at the American...Read more
All 12 patients who received the full dose of VX-880 as a single infusion demonstrated islet cell engraftment and glucose-responsive insulin production by Day 90 All patients achieved ADA-recommended target HbA1c levels <7.0% and >70% time-in-range (70-180 mg/dL), and 11 of 12 patients reduced or eliminated use of exogenous insulin 3 patients with at least 12 months of follow-up, and therefore evaluable, met the primary endpoint...Read more
Following a successful limited market release, the Omnipod 5 Automated Insulin Delivery System (Omnipod 5) is now fully available with Dexcom G6 and Abbott FreeStyle Libre 2 Plus in these countries ACTON, Mass. / Jun 20, 2024 / Business Wire / Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced that Omnipod 5, compatible...Read more
Omnipod 5, the world’s first tubeless automated insulin delivery (AID) system integrated with Dexcom G6, is now available in France Full commercial launch of Omnipod 5 with Dexcom G7 integration has commenced in the U.S. Omnipod 5 App for iPhone begins limited market release in the U.S. ACTON, Mass. / Jun 20, 2024 / Business Wire / Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump...Read more
US patients aged 10 years and older can now benefit from FARXIGA for type-2 diabetes Approval based on results from T2NOW, one of the largest pediatric type-2 diabetes Phase III trials to date WILMINGTON, Del. / Jun 12, 2024 / Business Wire / AstraZeneca’s FARXIGA® (dapagliflozin) has been approved by the US Food and Drug Administration (FDA) to improve glycemic control in pediatric patients with type-2 diabetes (T2D) aged 10 years...Read more
Abbott's consumer biowearable, Lingo™, is designed for general consumers who are looking to improve their overall health and wellness Libre Rio™ is designed for adults with Type 2 diabetes who do not use insulin and typically manage their diabetes through lifestyle modifications Both products are based on FreeStyle Libre® sensing technology, the world's most widely used1 continuous glucose monitoring (CGM) systems, pioneered by Abbott...Read more
REDWOOD CITY, Calif., June 06, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or the “Company”) (Nasdaq: BMEA), announced that the Company has received notice from the U.S. Food and Drug Administration (FDA) that a full clinical hold has been placed on Biomea’s ongoing Phase I/II clinical trials of the Company’s investigational covalent menin inhibitor BMF-219 in type 2 and type 1 diabetes (COVALENT-111 and COVALENT-112),...Read more
Nova Scotia becomes the latest province and territory to offer access to simple and easy-to-use diabetes management solutions, helping Canadians living with diabetes take control of their health BURNABY, British Columbia / Jun 03, 2024 / Business Wire / Dexcom, Inc. (NASDAQ: DXCM), a global leader in real-time continuous glucose monitoring (rtCGM) for people with diabetes, today announced that residents of Nova Scotia living with...Read more
DUBLIN, June 03, 2024 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB) a commercial stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced the launch of its continuous glucose monitoring (“CGM”) microsite - https://cgm.trinitybiotech.com. This website will be used to provide the Company’s stakeholders with key insights into the Company’s vision for...Read more
REDWOOD CITY, Calif., May 30, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, today announced the completion of enrollment of the first three dose expansion arms of COVALENT-111, with a total of over 260...Read more
Largest investment in active pharmaceutical ingredient manufacturing of synthetic medicines in U.S. history Since 2020, the company has committed more than $18 billion to build, upgrade and acquire facilities in the U.S. and Europe INDIANAPOLIS, May 24, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that it has more than doubled its investment in its Lebanon, Indiana, manufacturing site with a new...Read more
Efsitora met the primary endpoint in both QWINT-2 and QWINT-4 with once-a-week dosing regimen for people living with type 2 diabetes Efsitora was equally safe and effective among adults naïve to insulin therapy currently using and not using GLP-1 receptor agonists INDIANAPOLIS, May 16, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the QWINT-2 and QWINT-4 phase 3 clinical trials...Read more
First 14 participants with at least six months of follow up continue to demonstrate sustained improvements in blood glucose and weight with reduction in T2D medication utilization after a single Revita treatment No device- or procedure-related serious adverse events have been observed to date in any registry participant BURLINGTON, Mass., May 13, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a...Read more
DURAVYU demonstrates stable or improved disease severity with reduced rates of NPDR progression at nine months DURAVYU continues to demonstrate favorable safety and tolerability profile with no drug-related serious adverse events Conference call to discuss the results to be held at 8:00 a.m. ET WATERTOWN, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to...Read more
Vertex obtains an exclusive license to TreeFrog's C-StemTM manufacturing technology in type 1 diabetes TreeFrog and Vertex to collaborate on scale-up of fully differentiated, insulin-producing pancreatic islet cells BOSTON and BORDEAUX, France, April 23, 2024 /CNW/ -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and TreeFrog Therapeutics today announced that Vertex has obtained an exclusive license to...Read more
46.2% of patients demonstrated a 1- or 2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS) at 40 weeks in the AXPAXLI arm, compared to 0% in the control arm No patients in the AXPAXLI group experienced worsening in DRSS compared to 12.5% in the control arm at 40 weeks AXPAXLI was generally well tolerated with no inflammation observed Ocular intends to present the Phase 1 HELIOS study at an upcoming...Read more
Atherosclerosis (AS) and its sequelae are the most common cause of death in diabetic patients and one of the reasons why diabetes has entered the top 10 causes of death worldwide. The published data show that inhibiting the NLRP3 inflammasome pathway significantly reduces atherosclerotic lesions and improves hyperglycemic-induced plaque instability. ZyVersa is developing IC 100, a monoclonal antibody targeting inflammasome ASC and ASC...Read more
BMF-219 is an investigational novel covalent menin inhibitor developed to regenerate insulin-producing beta cells with the aim to cure diabetes The first two type 1 diabetes patients enrolled in COVALENT-112 both demonstrated early signs of clinical activity with improved measures of beta-cell function after initial treatment with BMF-219 BMF-219 has been well tolerated by both patients Open label portion of Phase II COVALENT-112...Read more
Bagsværd, Denmark, 21 March 2024 – Novo Nordisk (NYSE: NVO) today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending marketing authorisation for Awiqli® (the brand name for once-weekly basal insulin icodec) for treatment of diabetes in adults. The positive CHMP opinion is based on results from the ONWARDS phase 3a clinical trial...Read more
HOUSTON, March 19, 2024 /PRNewswire/ -- FibroBiologics, Inc., (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 150+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, announced the progress of a clinical program under development using a fibroblast-based pancreatic beta cell spheroid...Read more
Phase 2a trial is on track to begin in the first half of 2024. Cholesterol Efflux MediatorTM VAR 200 is in development to ameliorate renal lipid accumulation that damages the kidneys’ filtration system, leading to chronic kidney disease and its progression. WESTON, Fla., March 18, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing...Read more
WOBURN, Mass., March 14, 2024 (GLOBE NEWSWIRE) -- NeuroMetrix, Inc. (Nasdaq: NURO) noted the recent publication of a large study demonstrating that DPNCheck® combined with standard EKG or DPNCheck alone accurately detects diabetic peripheral neuropathy (DPN). Hayashi and colleagues evaluated 167 patients with Type 1 or Type 2 diabetes. The reference standard for DPN was a gold standard nerve conduction study. The authors developed a...Read more
Southlake, Texas, March 12, 2024 (GLOBE NEWSWIRE) -- Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announced the publication, in Cardiovascular Diabetology, of an independent, peer-reviewed study utilizing its...Read more
Study presented at ATTD 2024 is the first of a planned series examining the impact of Dario's integrated cardiometabolic solution as a means to address weight and diabetes with or without a GLP-1 Additional research presented demonstrated Dario's ability to improve awareness of the importance of flu vaccines in member with Type 2 diabetes NEW YORK, March 12, 2024 /PRNewswire/ -- DarioHealth Corp. (Nasdaq: DRIO) (the "Company"), a...Read more
THE WOODLANDS, Texas, March 12, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that a post hoc analysis of clinical data from its inTandem3 Phase 3 trial demonstrated that treatment with sotagliflozin resulted in improved glycemic control in patients with type 1 diabetes and chronic kidney disease (CKD). In this important patient population, treatment with sotagliflozin successfully lowered A1C, body...Read more
Efforts to advance chronic disease prevention through enhanced education, awareness and support — kicking off during National Kidney Month DENVER, March 11, 2024 /PRNewswire/ -- Today, The American Diabetes Association ® (ADA) and DaVita (NYSE: DVA), a leading provider of kidney care services, announced the expansion of a multi-year collaboration, focused on advancing chronic disease prevention, specifically addressing two of...Read more
Preparations Underway for Resubmission of New Drug Application for Sotagliflozin as an Adjunct to Insulin Therapy for Glycemic Control in Patients with Type 1 Diabetes and Chronic Kidney Disease Resubmission is Anticipated Mid-2024 THE WOODLANDS, Texas, March 11, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that, following the receipt of recent feedback from FDA, it is preparing to resubmit...Read more
Post-meal hyperglycemia was significantly reduced by 20% with inhaled insulin compared with rapid-acting insulin delivered through MDI or insulin pumps Subjects utilizing inhaled insulin experienced a 22% decrease in mean glucose excursions in the first two hours compared to the standard of care 17-week primary endpoint results will be presented during a 90-minute symposium at the American Diabetes Association’s Scientific Sessions in...Read more
PHOENIX / Mar 07, 2024 / Business Wire / Creative Medical Technology Holdings, Inc., (NASDAQ:CELZ), a leader in biotech innovation, today announced a major stride in combating Type 1 Diabetes Mellitus (T1D). The company has secured FDA authorization for an expanded access therapy using CELZ-201, a pioneering cell-based program in managing abnormal glucose tolerance and preventing T1D in high-risk individuals. This groundbreaking therapy...Read more
Data analyses show that people with Type 2 diabetes using GLP-1 medicines saw a significant improvement in their HbA1C after adding FreeStyle Libre technology to their regimen Better HbA1c results were achieved irrespective of GLP-1 duration, GLP-1 type, or insulin therapy type FreeStyle Libre systems help people adhere to diabetes treatment plans and support positive behavior changes by providing real-time data that shows how food,...Read more
Stelo will be the first glucose biosensor in the US cleared for use without a prescription Indicated for use for people 18 years and older who are not using insulin therapy A small, wearable sensor worn on the back of the upper arm, Stelo will provide glucose insights directly to a user’s smartphone† Created by the makers of Dexcom G7, the most accurate,1 easy-to-use2 and clinically-proven CGM brand,3-7 Stelo will empower even more...Read more
Multiple DehydraTECH-GLP-1 and DehydraTECH-CBD formulations to be tested Chronic dosing over a 12-week treatment period Will assess weight loss and blood glucose level control Efficacy through possible brain absorption delivery enhancement to be assessed KELOWNA, BC / ACCESSWIRE / March 5, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms...Read more
Bagsværd, Denmark, 5 March 2024 – Novo Nordisk today announced the headline results from the kidney outcomes trial FLOW. The announcement today follows the decision to stop the trial early due to efficacy, which was announced on 10 October 2023, based on a recommendation from an Independent Data Monitoring Committee. The double-blind trial compared injectable semaglutide 1.0 mg with placebo as an adjunct to standard of care for...Read more
HIGH POINT, N.C., March 04, 2024 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of cadisegliatin (TTP399) as an adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D"), today announced the submission of the study protocol to the FDA for the Company’s first Phase 3 trial evaluating the safety and efficacy of its lead candidate,...Read more
Reached enrollment goal of 305 patients living with Type 1 or Type 2 diabetes Primary endpoint analysis expected in 4Q 2024 Data dissemination and FDA submission expected in 2025 DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Feb. 15, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung...Read more
Transplant of HIP-modified pancreatic islet cells provided lasting glucose control in a fully immunocompetent non-human primate (NHP), enabling the achievement of exogenous insulin independence without immunosuppression for six month study duration Administration of anti-CD47 antibody after six months demonstrated the principle of graft ablation and a potential safety strategy SEATTLE, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Sana...Read more
SAN DIEGO / Feb 13, 2024 / Business Wire / Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today announced the United States commercial launch of its new Tandem Mobi, the world’s smallest, durable automated insulin delivery system for people living with diabetes.* The company has begun taking orders and shipping to eligible customers in the United States. Tandem Mobi is a new way for...Read more
COMBINE 3 phase 3a trial successfully completed with once-weekly IcoSema demonstrating non-inferior reduction in HbA1c versus daily basal-bolus treatment (insulin glargine U100 and insulin aspart) in people with type 2 diabetes Bagsværd, Denmark, 8 January 2024 – Novo Nordisk today announced topline results from the COMBINE 3 phase 3a trial of once-weekly IcoSema, a fixed-ratio combination of basal insulin icodec and...Read more
Closes acquisition of exclusive, worldwide license to Tolimidone, Phase II Ready Type I Diabetes clinical program CARDIFF, United Kingdom, Dec. 21, 2023 (GLOBE NEWSWIRE) - Biodexa Pharmaceuticals PLC, (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, today announced the closing of an underwritten public offering of units for...Read more
CHICAGO, IL / ACCESSWIRE / December 20, 2023 / Cosmos Health Inc. ("Cosmos Health" or the "Company'') (NASDAQ:COSM), a diversified, vertically integrated global healthcare group engaged in innovative R&D, owner of proprietary pharmaceutical and nutraceutical brands, manufacturer and distributor of healthcare products, and operator of a telehealth platform, announced today that it has entered into a definitive agreement, subject to...Read more
SAN DIEGO / Dec 12, 2023 / Business Wire / Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today announced the launch of Tandem Source, a diabetes management platform for insulin pump users and healthcare providers (HCPs). Tandem Source is designed to bring together the features of Tandem’s legacy t:connect, t:connect HCP, and t:connect Portal offerings with new comprehensive data...Read more
BMF-219 is an investigational novel covalent menin inhibitor developed to regenerate insulin-producing beta cells with the aim to cure diabetes At Week 26, 22 weeks after the last dose of BMF-219, participants in the 100 mg QD (without food) cohort saw an improved placebo adjusted mean reduction in HbA1c of 0.8% (compared to a 0.7% placebo adjusted mean reduction in HbA1c at Week 4) Observed HbA1C reduction was supported by an...Read more
BMF-219 is an investigational novel covalent menin inhibitor developed to regenerate insulin-producing beta cells with the aim to cure diabetes In a poster presentation on Thursday, Dec. 7th at 6:30pm and an oral presentation on Friday, Dec. 8th at 7:30pm, Biomea to present new preclinical and clinical data highlighting: A sustained HbA1C reduction of ≥0.5% and ≥1.0% in 40% and 20% of patients, respectively, 22 weeks after the last...Read more
Diabetic kidney disease (DKD), which affects around 240 million people with Type 2 diabetes worldwide, is the leading cause of end-stage renal disease, which requires dialysis or kidney transplant for survival. The article published in Alternative Therapies demonstrates that plasma NLRP3 inflammasomes and their resulting proinflammatory cytokines are significantly elevated in early-stage DKD and that levels progressively increase as...Read more
First Automated Insulin Delivery System in the World to Feature Dexcom’s Most Advanced CGM Technology SAN DIEGO / Dec 06, 2023 / Business Wire / Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today announced the launch of updated t:slim X2™ insulin pump software with Dexcom G7 Continuous Glucose Monitoring (CGM) integration in the United States. Tandem’s #1-rated automated...Read more
Atherosclerosis, an inflammatory disease characterized by buildup of cholesterol, lipids, and other substances (plaque) in arteries leading to heart attack and stroke, is accelerated in patients with diabetes. The study published in Diabetes demonstrates that AIM2 and NLRP3 inflammasome activation leads to development of atherosclerotic lesions in diabetic mice. ZyVersa is developing Inflammasome ASC Inhibitor IC 100, which inhibits...Read more
WINNIPEG, MB / ACCESSWIRE / December 5, 2023 / Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH) (OTC PINK:MCUJF), a company focused on the development and commercialization of pharmaceuticals and healthcare products for patients and prescribers in the United States market, through its pharmacy subsidiary Marley Drug®, a trusted national pharmacy known for its commitment to affordable healthcare solutions, is pleased to announce a...Read more
BMF-219 is a novel investigational covalent menin inhibitor developed to regenerate insulin-producing beta cells with the aim to cure diabetes Health Canada has cleared the initiation of COVALENT-112, a Phase II clinical trial of BMF-219 in adults living with type 1 diabetes (T1D), following FDA clearance of the initiation of COVALENT-112 in October 2023 The randomized, double-blind, placebo-controlled (n=150) trial in adults living...Read more
Carmot Therapeutics’s R&D portfolio of clinical stage incretins has great potential to treat obesity, diabetes and potentially other diseases both as standalone medicines and in combination with Roche’s in-house assets Lead asset CT-388 is a Phase-2 ready dual GLP-1/GIP agonist with best-in-class potential for the treatment of obesity and its comorbidities Under the terms of the agreement, Roche will pay a purchase price of USD 2.7...Read more
VANCOUVER, BC, Dec. 4, 2023 /CNW/ - PreveCeutical Medical Inc. (the "Company" or "PreveCeutical") (CSE: PREV) (OTCQB: PRVCF) (FSE: 18H), is pleased to announce that it has started preparations to accelerate completion of its preclinical dual gene therapy program using our developed and in vitro validated Smart-siRNA sequences, which when paired with our proprietary bioresponsive lipid-nanoparticulate delivery systems (US patent...Read more
Highlights: Acquisition of exclusive worldwide license to develop and commercialize tolimidone Phase II ready with encouraging signals of β cell proliferation in preclinical models Extensive safety database as Tolimidone exposed to approximately [700] patients in other indications Cardiff , Nov. 27, 2023 (GLOBE NEWSWIRE) -- 27 November 2023 - Biodexa Pharmaceuticals PLC, (Nasdaq: BDRX), a clinical stage biopharmaceutical company...Read more
New clinical data from all dosing cohorts (n=62) initiated to date from the escalation portion of COVALENT-111 and long-term (26 weeks) follow-up data of the 200 mg dosed cohorts will be featured during an oral Poster Discussion Presentation and two Poster Viewing Presentations at ATTD REDWOOD CITY, Calif., Nov. 27, 2023 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company...Read more
C4 Therapeutics is pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins via degradation using the innate machinery of the cell. This targeted protein degradation approach offers advantages over traditional drugs, including the potential to treat a wider range of diseases...
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