Category Archives: Topics

CBO Hints at Medicare Coverage for Obesity Drugs; AZ Initiates Ph3 Balcinrenone/Dapa Trial

Two cardiometabolic-related news items have been observed: The CBO has hinted at potential Medicare coverage for obesity drugs, such as Wegovy and Zepbound (view article); and AZ initiated a Ph3 balcinrenone+dapa trial in HF and impaired kidney function (view CT.gov record). Below, FENIX provides highlights and insights from the respective news items.

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Ionis Ph2 MASH Results; New BI Ph3 Survodutide MASH Trial; Silence Ph2 Lp(a) Results; Lilly Partners with Amazon Pharmacy; Arecor Partners for Oral GLP-1RA; Ascensia Expands PSP

A series of cardiometabolic-related news items have been observed from Ionis Pharmaceuticals, Boehringer Ingelheim, Silence Therapeutics, Lilly, Arecor Therapeutics, and Ascensia Diabetes Care. Below, FENIX provides highlights and insights for the respective news items.

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Lexicon Sota T1DM Indication and CKM; Lilly Expands Redwire Collaboration; 89bio Initiates Ph3 ENLIGHTEN MASH Program; Fractyl Reports Preclinical Rejuva Findings; Welldoc Receives CE Mark for Bluestar

A series of cardiometabolic-related news items have been observed from Lexicon, Lilly/Redwire, 89bio, Fractyl Health, and Welldoc. Below, FENIX provides highlights and insights for the respective news items, including thoughts on how Lexicon’s sotagliflozin T1DM indication may be linked to the future continuous ketone monitor from Abbott.

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ATTD 2024 Key Press Releases Day 4 (March 9)

On the last day of ATTD 2024, two cardiometabolic-related news items have been observed: Dexcom announced its direct-to-watch feature for G7 will begin a phased launch in Q2 ’24 (view press release); and Medtronic announced new clinical and real-world MiniMed 780G AID data at ATTD 2024 (view press release). Below, FENIX provides highlights and insights for the respective news items.

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SELECT Approved by FDA

Novo Nordisk announced FDA approved the Wegovy label expansion to reduce the risk of MACE including CV death, non-fatal MI, or non-fatal stroke in adults with either overweight or obesity and established CVD. The approval is based on the SELECT CVOT which demonstrated -20% RRR in 3P-MACE for non-T2DM people with established CVD who were treated with QW 2.4mg semaglutide (previous FENIX insight). FENIX will conduct a full label analysis of the SELECT label in the coming days. In case you missed it, FENIX conducted a full SELECT results analysis in November 2023 (previous FENIX insight).

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ATTD 2024 Key Press Releases Day 1 (March 6)

On the first day of ATTD 2024, seven cardiometabolic-related news items were observed from Roche, Dexcom, Abbott, Lilly, Know Labs, Akero, and Biomea Fusion. Below, FENIX provides highlights and insights for the respective news items.

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