In the News... New research in T1D prevention, fast-acting biosimilar insulin approved, Lilly lowers Zepbound price, and more!

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: New drug is looked at for T1D prevention, a new stem cell method is tested for beta cell transplanation without immunosuppresion drugs, the FDA okays the first fast-acting biosimilar insulin, Lilly lowers price of Zepbound, and more!

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Episode transcription with links:

 

Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now.

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New research in type 1 diabetes prevention launches. Nektar Therapeutics and TrialNet will evaluate a drug currently used for exzema for patients with new onset stage 3 type 1 diabetes

The drug is RezPeg – that’s a shortened version of the name (rezpegaldesleukin)   This will be a study of about 70 adults and children and will launch this year.

The new study will use a mixed meal tolerance test (MMTT) to measure the efficacy of rezpegaldesleukin or placebo for preserving C-peptide area under the curve over a 12-month duration comprised of a 6-month treatment period and a 6-month follow-up. Secondary objectives include pharmacokinetics, pharmacodynamics, and additional disease assessments including HbA1c levels and patient insulin requirements.

Rezpegaldesleukin is being developed as a self-administered injection for a number of autoimmune and inflammatory diseases.

https://www.prnewswire.com/news-releases/nektar-announces-clinical-trial-agreement-to-evaluate-rezpegaldesleukin-in-patients-with-new-onset-type-1-diabetes-mellitus-302383052.html

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NLS Pharmaceutics (NLSP) and Kadimastem announced successful completion of a pre-IND meeting with the FDA for iTOL-102, a potential diabetes treatment. iTOL-102 combines Kadimastem's IsletRx cells (stem cell-derived pancreatic islets) with iTolerance's immunomodulator iTOL-100, aiming to cure Type 1 Diabetes without requiring life-long immune suppression.

The treatment was evaluated at the Diabetes Research Institute at the University of Miami School of Medicine, where it demonstrated functional insulin release and disease reversal in animal models. Based on FDA feedback, the companies are updating plans for safety toxicology studies and First-in-Human clinical trials.

IsletRx is a clinical-grade product comprising human pancreatic islet-like cells capable of secreting insulin, offering a scalable source of insulin-producing cells to address donor islet shortages. The technology can detect glucose levels and produce required amounts of insulin and glucagon.

 

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FDA has signed off on a rapid-acting insulin biosimilar for the first time. The agency has given a thumbs up to Sanofi’s Merilog (insulin-aspart-szjj) as the first biosimilar to Novo Nordisk’s NovoLog for patients with diabetes.

Merilog will be provided by prefilled pen in a 3 mL dose or in a multiple-dose 10 mL vial. It is for adults and pediatric patients age 6 and older.

 

 

NovoLog and Novo Nordisk’s other rapid-acting insulin follow-on Fiasp are among the drugs subject to government price negotiations under the Inflation Reduction Act. The new prices will be enacted at the start of next year.

In July 2021, the FDA approved Biocon and Viatris’ Semglee (insulin glargine-yfgn) as the first biosimilar to Lantus. Five months later, the U.S. regulator endorsed Eli Lilly’s version of the drug, called Rezvoglar (insulin glargine-aglr).

https://www.fiercepharma.com/pharma/fda-signs-sanofis-biosimilar-first-novo-nordisks-rapid-acting-novolog

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Eli Lilly said Tuesday that it will offer more doses of its obesity drug Zepbound in vials and lower the prices of the doses it already sells, as the pharma giant seeks to draw patients away from cheap, compounded copies of weight loss medications.

The company launched 7.5 mg and 10 mg vials of tirzepatide, sold under the brand name Zepbound, which typically cost $599 and $699, respectively. However, they are now available for $499 per month for patients paying without insurance. This applies to the first fill and all refills that are delivered every 45 days.

Additionally, the company lowered the prices of the 2.5 mg and 5 mg vials to $349 and $499 per month, respectively.

The company, which has seen a significant boost in profits from Zepbound and Mounjaro – essentially the same drug with different FDA-approved uses – announced that the new vials and pricing are exclusively available through the company’s self-pay pharmacy, LillyDirect Self Pay Pharmacy Solutions.

https://www.bloomberg.com/news/articles/2025-02-25/zepbound-cost-for-vials-cut-to-battle-cheaper-copycats

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Medicare spending on 10 diabetes drugs, including popular GLP-1s, more than quadrupled over a five-year period and could reach $102 billion next year, an analysis by Health and Human Services' inspector general found.

The findings also come as the Trump administration weighs the fate of a Biden administration proposal that would require Medicare and Medicaid to cover GLP-1s for weight loss.

The biggest spikes in usage were for Rybelsus, Novo Nordisk's once-daily GLP-1 tablet, and for the company's weekly injectable Ozempic, whose spending about doubled every year under review.

https://www.axios.com/2025/02/25/medicare-spending-surge-diabetes-drugs

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Tandem Diabetes Care has secured a new FDA clearance for its insulin dose-calculating algorithm, opening up Control IQ for use in adults with Type 2 diabetes.

The expanded label was based on data from a pivotal, randomized trial of more than 300 people with Type 2 diabetes, comparing its use to manual multiple daily injections. Tandem said it plans to present the study’s results at the annual Advanced Technologies & Treatments for Diabetes meeting scheduled for next month in Amsterdam.

https://www.fiercebiotech.com/medtech/tandem-diabetes-care-insulin-dosing-algorithm-nets-fda-clearance-type-2-diabetes

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Drugs approved for diabetes and obesity might be useful for the treatment of cognitive and mental health disorders, according to a new paper published in Nature Mental Health.

 

The study reviewed and integrated data from both preclinical and clinical studies to gather evidence on the possible effects of these drugs GLP1s and semaglutide  in conditions such as dementia, substance use disorders, psychotic disorders, mood and anxiety disorders, and eating disorders.

 

 

The study found promising but still preliminary evidence that GLP-1RAs could be beneficial over a range of cognitive and mental health disorders. These drugs have shown potential in improving cognition, reducing addictive behavior, and alleviating depression and anxiety. More data from robustly designed studies (i.e., randomized controlled trials) are needed to better understand GLP-1RAs' prospective efficacy and safety profile, especially with long-term use.

https://medicalxpress.com/news/2025-02-diabetes-drugs-mental-health-treatment.html

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The FDA  issued draft guidance that includes recommendations to support the development and marketing of safe and effective AI-enabled

The guidance, if finalized, would be the first guidance to provide comprehensive recommendations for AI-enabled devices throughout the total product lifecycle, providing developers with an accessible set of considerations that tie together design, development, maintenance, and documentation recommendations to help ensure the safety and effectiveness of AI-enabled devices.

FDA is requesting public comment on this draft guidance by April 7.

The agency also released draft guidance for the use of AI to support regulatory decision-making for drug and biological products.

https://www.mddionline.com/artificial-intelligence/fda-issues-draft-guidance-for-ai-enabled-devices-seeks-public-feedback

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Congrats to Mila Clarke who some of you may know better as Hangry Woman on social. She has developed a great app called Glucose Guide and the Nutrition Assistant portion of that app went live this week.

Glucose Guide is a web and mobile app that offers diabetes meal tracking, coaching, resources, recipes and community to those looking for help managing diabetes. MEAL AND BLOOD SUGAR TRACKING FEATURES. 📢

🗓️Mark your calendars for our launch on February 26!

📰 Make sure you're signed up for my newsletter, so you know when these features go live: https://hangrywoman.myflodesk.com/subscribe

💥Plus, if you are one of the first 100 people to sign up on launch day, you'll get a VERY special deal.

📲I'll be sharing some sneak peeks of our new tools. I'm over the moon. FINALLY a tracker that keeps blood sugar tracking aligned with meal tracking, exercise, sleep, mood, and more. Oh, and did I mention it'll analyze your fridge? You can scan photos of your plate and it will give you recommendations on what to adjust for better blood sugar balance?

https://nutrition.glucoseguide.app/

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And finally, gold medal Olympian Jordan Chiles is speaking out about diabetes. The gymnast’s aunt lives with type 1. Chiles is teaming up with Sanofi to talk about auto antibody screening

https://beyondtype1.org/gymnast-jordan-chiles-personal-reason-for-type-1-diabetes-advocacy/