Category Archives: Topics

SELECT up for CHMP Opinion?; January CHMP Agenda; Akero Initiates Ph3 EFX MASH Trial

Two cardiometabolic-related news items have been observed: the CHMP agenda (view here) for this month’s meeting (January 22-25) has been released and includes Novo’s SELECT; and Akero initiated the second Ph3 study evaluating EFX in participants with non-cirrhotic MASH and F2 or F3 fibrosis (SYNCHRONY Histology; view CT.gov record). Below, FENIX provides highlights and insights for the respective news items.

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Lilly to Launch Mounjaro in EU; FDA Posts Libre 3 Android App Recall; Novo Initiates Ph1 Cagrisema Study in Weight Loss Mechanisms

Three cardiometabolic-related news items have been observed: Lilly has reportedly planned additional Mounjaro launches in 2024 once it receives EU approval for its pen injector (view article); FDA posted a Class 2 device recall for the Libre 3 Android App which was resolved in February 2023 (view recall); and Novo initiated a Ph1 cagrisema study (view CT.gov record). Below, FENIX provides highlights and insights for the respective news items.

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JPM 2024 Day 4: MDGL, LXRX, MNKD, AKBA, and XERS; Novartis No Longer Pursuing Cytokinetics Acquisition

On the fourth and last day of JPM 2024, FENIX has provided coverage of presentations by other CVRM companies, including Madrigal, Lexicon, MannKind, and Akebia. Xeris also presented at JPM 2024 but had no meaningful discussion relating to its CVRM portfolio. Separately, one CVRM-related news item has been observed: Novartis has reportedly decided to no longer pursue a Cytokinetics acquisition (view article).

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JPM 2024 Day 3: TRNS, ESPR, IONS, AMRN, EMBC, and VTRS

On the third day of JPM 2024, FENIX has provided coverage of presentations by other CVRM companies, including Terns, Esperion, Ionis, Amarin, Embecta, and Viatris. Tomorrow is the final day of the JPM 2024 conference with presentations from Lexicon, Mannkind, and Xeris.

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JPM 2024 Day 2: ABT, PODD, NVO, LLY, AZN, BAY, BMF, TDOC; Embecta Files 510(k) for T2DM Patch Pump; Omada Partners with Amazon for Cardiometabolic Programs

On the second day of JPM 2024, FENIX has provided coverage of presentations by major CVRM companies, including Abbott, Insulet, Novo Nordisk, Lilly, AZ, Bayer, Biomea, and Teladoc. GSK and Sanofi also presented at JPM 2024 but had no meaningful discussion relating to their respective CVRM portfolios. Separately, two CVRM-related news items have been observed: Embecta announced it submitted a 510(k) filing to FDA for its open-loop patch pump for T2DM (view press release); and Omada Health announced a partnership with Amazon’s Health Condition Programs for its cardiometabolic programs (view press release).

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JPM 2024 Day 1: DXCM, MDT, AMGN, AKERO, ARWR, CYTO, NVS, VRTX, ALN, REGN; Tandem X2 Control-IQ Integrated with Libre 2 Plus; Supersapiens Launches Diabetes Platform; Novo Ph3 Icosema Results

On the first day of JPM 2024, FENIX has provided coverage of presentations by major CVRM companies, including Dexcom, Medtronic, Amgen, Akero, Arrowhead, Cytokinetics, Novartis, Vertex, Alnylam, and Regeneron. Pfizer and Merck also presented at JPM 2024 but had no meaningful discussion relating to their respective CVRM portfolios. Additionally, three separate CVRM-related news items have been observed: Tandem and Abbott announced the Tandem X2 Control-IQ AID system now integrates with Abbott’s Libre 2 Plus CGM (view press release); Novo announced topline results from the COMBINE 3 study evaluating icosema vs. basal-bolus treatment in T2DM (view press release); and Supersapiens announced the launch of its Supersapiens Diabetes platform (view post).

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Roche Restructures Diabetes Business; Novo Partners for Obesity and MASH; BI Partners with Ribo for MASH; Lilly Issues Open Letter on Off-Label Mounjaro/Zepbound Use; Lilly Launches Diabetes/Obesity Digital Health Program; Evaluate Projects Novo and Lilly to Top 2024 Global New Sales

A series of cardiometabolic-related news items have been observed from Roche, Novo, Lilly, BI, and Evaluate. Below, FENIX provides highlights and insights for the respective news items.

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