• In the News... BIG beta cell transplant news, a new pump team-up, FDA moves on GLP-1 compounds, and more!

  • 2025/01/10
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In the News... BIG beta cell transplant news, a new pump team-up, FDA moves on GLP-1 compounds, and more!

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  • It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Sana announces beta cell transplantation without the need for immunosuppresion drugs, Modular Medical teams up with Nudge BG for a brand new completely closed-loop system, the FDA moves forward to crack down on compounded Ozempic and Mounjaro, Dexcom and Abbott bury the legal hatchett for a while, and more. Find out more about Moms' Night Out 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 Learn about Dexcom Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens Drive research that matters through the T1D Exchange 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 Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com Reach out with questions or comments: info@diabetes-connections.com 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. XX Big news from Sana Biotechnology. Their first in human study of islet cells without any immunosuppression appears to be a success. This is very early and hasn’t yet been peer reviewed and published.. but after four weeks, there were no safety issues and the transplanted beta cells were producing insulin. Sana’s CEO says “As far as we are aware, this is the first study showing survival of an allogeneic transplant with no immunosuppression or immune-protective device in a fully immune competent individual. Safe cell transplantation without immunosuppression has the potential to transform the treatment of type 1 diabetes and a number of other diseases.” I’ve reached out to Sana to get more on this.. love to talk to them soon. https://www.bakersfield.com/ap/news/sana-biotechnology-announces-positive-clinical-results-from-type-1-diabetes-study-of-islet-cell/article_d0390fd6-99cb-53bd-b04d-9337121e01bf.html XX FDA says no for sotagliflozin as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD). Studies showed a meaningful reduction in A1C but a meaningful increase in DKA. The FDA first rejected this in 2019 and was resubmitted last summer. But The advisory committee voted 11 to 3 against the approval of sotagliflozin stating that the benefits of sotagliflozin do not outweight the risks in adults with T1D and CKD. Sotagliflozin is currently approved under the brand name Inpefa to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with 1) heart failure; or 2) type 2 diabetes mellitus, CKD, and other cardiovascular risk factors. According to Lexicon, Inpefa will continue to be manufactured and made available to patients. https://www.renalandurologynews.com/news/fda-denies-approval-of-zynquista-for-type-1-diabetes-and-ckd/ XX Two companies we’ve been following are teaming up.. Modular Medical has an FDA clear patch pump and Nudge BG has an adaptive full closed loop. They’ve announced a new partnership agreement. From the release: Modular Medical's easy-to-use and cost-effective MODD1 insulin pump technology. Our combined system is intended to nudge blood glucose by making small changes to insulin delivery based on estimated glucose inputs from a continuous glucose monitor." Familiar name to some of you, Lane Desborough is the founder of Nudge BG. He says this will be a fully automated system, no mealtime bolusing needed. https://www.accesswire.com/957703/modular-medical-announces-licensing-and-partnership-agreement-with-nudge-bg XX Beta Bionics filed for an initial public offering on Monday. The company did not disclose the number of shares it will offer or the price range. Beta Bionics plans for shares to be listed on the Nasdaq under the ticker symbol “BBNX.” The Irvine, California-based company makes an insulin pump called the iLet Bionic Pancreas, which was cleared by the Food and Drug Administration in 2023. Beta Bionics plans to use the proceeds to grow its sales and manufacturing infrastructure and develop new features for its device. https://www.medtechdive.com/news/beta-bionics-insulin-pump-files-ipo/736805/ XX Tandem Diabetes Care, Inc. signed a multi-year collaboration agreement with the University of Virginia Center for Diabetes Technology (UVA) to advance research and development efforts on fully automated ...
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It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Sana announces beta cell transplantation without the need for immunosuppresion drugs, Modular Medical teams up with Nudge BG for a brand new completely closed-loop system, the FDA moves forward to crack down on compounded Ozempic and Mounjaro, Dexcom and Abbott bury the legal hatchett for a while, and more. Find out more about Moms' Night Out 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 Learn about Dexcom Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens Drive research that matters through the T1D Exchange 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 Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com Reach out with questions or comments: info@diabetes-connections.com 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. XX Big news from Sana Biotechnology. Their first in human study of islet cells without any immunosuppression appears to be a success. This is very early and hasn’t yet been peer reviewed and published.. but after four weeks, there were no safety issues and the transplanted beta cells were producing insulin. Sana’s CEO says “As far as we are aware, this is the first study showing survival of an allogeneic transplant with no immunosuppression or immune-protective device in a fully immune competent individual. Safe cell transplantation without immunosuppression has the potential to transform the treatment of type 1 diabetes and a number of other diseases.” I’ve reached out to Sana to get more on this.. love to talk to them soon. https://www.bakersfield.com/ap/news/sana-biotechnology-announces-positive-clinical-results-from-type-1-diabetes-study-of-islet-cell/article_d0390fd6-99cb-53bd-b04d-9337121e01bf.html XX FDA says no for sotagliflozin as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD). Studies showed a meaningful reduction in A1C but a meaningful increase in DKA. The FDA first rejected this in 2019 and was resubmitted last summer. But The advisory committee voted 11 to 3 against the approval of sotagliflozin stating that the benefits of sotagliflozin do not outweight the risks in adults with T1D and CKD. Sotagliflozin is currently approved under the brand name Inpefa to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with 1) heart failure; or 2) type 2 diabetes mellitus, CKD, and other cardiovascular risk factors. According to Lexicon, Inpefa will continue to be manufactured and made available to patients. https://www.renalandurologynews.com/news/fda-denies-approval-of-zynquista-for-type-1-diabetes-and-ckd/ XX Two companies we’ve been following are teaming up.. Modular Medical has an FDA clear patch pump and Nudge BG has an adaptive full closed loop. They’ve announced a new partnership agreement. From the release: Modular Medical's easy-to-use and cost-effective MODD1 insulin pump technology. Our combined system is intended to nudge blood glucose by making small changes to insulin delivery based on estimated glucose inputs from a continuous glucose monitor." Familiar name to some of you, Lane Desborough is the founder of Nudge BG. He says this will be a fully automated system, no mealtime bolusing needed. https://www.accesswire.com/957703/modular-medical-announces-licensing-and-partnership-agreement-with-nudge-bg XX Beta Bionics filed for an initial public offering on Monday. The company did not disclose the number of shares it will offer or the price range. Beta Bionics plans for shares to be listed on the Nasdaq under the ticker symbol “BBNX.” The Irvine, California-based company makes an insulin pump called the iLet Bionic Pancreas, which was cleared by the Food and Drug Administration in 2023. Beta Bionics plans to use the proceeds to grow its sales and manufacturing infrastructure and develop new features for its device. https://www.medtechdive.com/news/beta-bionics-insulin-pump-files-ipo/736805/ XX Tandem Diabetes Care, Inc. signed a multi-year collaboration agreement with the University of Virginia Center for Diabetes Technology (UVA) to advance research and development efforts on fully automated ...
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