Category Archives: Glucose Monitoring

July CHMP Agenda; MiniMed 780G CE Mark for Expanded Indication; Dexcom Receiver Recall  

Three cardiometabolic-related news items have been observed: The CHMP agenda for this month’s meeting (July 21-24) has been released (view here); Medtronic announced its MiniMed 780G pump received CE Mark for ages 2+ years of age, T2DM, and during pregnancy (view press release); and FDA announced Dexcom’s CGM receivers have been recalled for faulty alert sounds (view press release). Below, FENIX provides highlights and insights for the respective news items, including thoughts on Novo’s EU semaglutide MASH regulatory strategy.

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Lifescan Restructures Debt; Madrigal’s Rezdiffra Gains Patent in US 

Two cardiometabolic-related items have been observed: Lifescan entered into a Restructuring Support Agreement with its equity partner to restructure debt (view press release); and Madrigal Pharmaceuticals has been granted a US patent for Rezdiffra’s weight-based dosing regimen for the treatment of noncirrhotic MASH (view press release). Below, FENIX provides highlights and insights for the respective news items.

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AstraZeneca Ph3 Baxdrostat Topline Results; FDA Approves Bayer’s Kerendia for HFpEF; Mattel Launches Barbie with T1DM 

Three cardiometabolic-related news items have been observed: AstraZeneca announced positive Ph3 topline results for baxdrostat in hypertension (view press release; view CT.gov record), Bayer announced FDA approval of Kerendia’s (finerenone) HEpEF indication (view press release), and Mattel announced the launch of a Barbie with diabetes (view press release). Below, FENIX provides highlights and insights for the respective news items.

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ADA 2025 Key Press Releases (June 23)  

On the final day of the ADA 2025 conference, six cardiometabolic-related news items have been observed from Amgen, Novo Nordisk, Lilly, Lexicon Pharmaceuticals, and Terns Pharmaceuticals. Of note, Amgen is hosting an investor call discussing the MariTide Ph2 results, and FENIX will provide updated thoughts after the team heads back from Chicago, including a benefit/risk analysis of conducting a H2H trial vs. tirzepatide. Below, FENIX provides context and analysis for the announcements.

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Beta Bionics Investor Event at ADA 2025

Beta Bionics (BB) hosted an investor event and associated webcast at ADA 2025 (view slides). As seen by FENIX, in-room attendance was convincingly robust. Below, FENIX provides a summary and insights from the event, including BB’s new patch pump named “Mint.”

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ADA 2025 Key Press Releases (June 20) 

On the first day of the ADA 2025 conference, seven cardiometabolic-related news items have been observed from Novo Nordisk, Tandem Diabetes Care, Beta Bionics, Ypsomed/CamDiab, Madrigal Pharmaceuticals, and Pfizer. Below, FENIX provides context and analysis for the announcements. 

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