In the News... New islets study, Tzield for babies, MiniMed Go approved, Civica insulin launched, and more! copertina

In the News... New islets study, Tzield for babies, MiniMed Go approved, Civica insulin launched, and more!

In the News... New islets study, Tzield for babies, MiniMed Go approved, Civica insulin launched, and more!

Ascolta gratuitamente

Vedi i dettagli del titolo

A proposito di questo titolo

 It's In the News... the top diabetes stories and headlines happening now! Top stories this week include: new islet encapsulation trial, FDA agrees to review Tzield for babies and approves the MiniMed Go, Civica releases it's version of Lantus, Eversense launches with a pump partner, scholarship for college students with diabetes and more! Announcing Community Commericals! Learn how to get your message on the show here. Learn more about studies and research at Thrivable here Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life All about Dexcom Screen it Like You Mean It All about VIVI Cap to protect your insulin from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com Episode transcript: Welcome! This is an In the News episode.. we're doing things a little differently this year, but we are still bringing you the top diabetes stories and headlines happening now. We are rotating these shorter episodes with our longer, interview episodes.. but all on Tuesdays now. And that's why you'll hear ads on the in the news episodes. My usual disclaimer – we believe in the products advertised here but no one tells me what stories to run or what to say – the commercials are separate from the news. I know most podcasters don't do disclaimers anymore, but I come from traditional broadcasting and it's still important to me. Okay.. our top story this week: XX Positive results for a phase 1 clinical trial of encapsulated islets in people with type 1 from Encellin. This first-in-human trial is assessing (1) safety and adverse events, (2) cell survival within the device, and (3) fibrosis, or scarring, around the implants. As planned, ENCRT devices were removed from the initial five participants after 4 months of implantation. Analysis of the removed devices show: minimal to no fibrosis (formation of scar tissue around the device); robust formation of blood vessels around the device; viable islets inside the device. These results indicate that the device has the potential to host islet cells while maintaining sufficient oxygen and nutrient flow for the cells to work effectively. Breakthrough T1D's Role: Encellin's technology was originally developed within the Lab of Dr. Tejal Desai (University of California San Francisco) with funding from Breakthrough T1D, which was crucial in the formation of Encellin as a company and attracting subsequent venture capital. https://breakthrought1d.ca/cell-therapy-trial-encellins-device-delivers-promising-early-results/ XX The US Food and Drug Administration has accepted Tzield for priority review to expand the current age indication from eight years and above, to as young as one year old and above to delay the onset of stage 3 type 1 diabetes (T1D) in patients diagnosed with stage 2 T1D. The target action date for the FDA decision is April 29, 2026. "This priority review emphasizes the urgent need for innovative therapies like Tzield which has the potential to prevent the natural progression of T1D by delaying the loss of endogenous insulin production. This might be particularly significant in this young population, as it is well documented that the autoimmune attack that drives this disease in many cases, begins, early in life," said Christopher Corsico, Global Head of Development at Sanofi. "If approved, Tzield could represent an important advance for delaying the onset of stage 3 type 1 diabetes in early childhood, which would benefit patients and caregivers alike." Interim data for the PETITE-T1D phase 4 study was presented at the 51st Annual Conference of the International Society for Pediatric and Adolescent Diabetes and simultaneously published in Diabetologia. Priority review is given to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. The safety and efficacy of Tzield in the PETITE-T1D population has not been approved by any regulatory authority. https://www.globenewswire.com/news-release/2026/01/05/3212420/0/en/Press-Release-Sanofi-s-Tzield-accepted-for-priority-review-in-the-US-for-young-children-with-stage-2-type-1-diabetes.html XX Sanofi said the U.S. Food and Drug Administration accepted a priority review to potentially expand the current age range for its Tzield type-1 diabetes drug to include children as young as one year old. The French pharmaceutical company said Monday that the FDA's review could amend the lower end of the range for ...
Ancora nessuna recensione