Category Archives: Dual/triple agonist

Dexcom and Sanofi Q3 ’24 Earnings; Zepbound Label Update

Three cardiometabolic-related news items have been observed: Dexcom hosted its Q3 ’24 earnings call (press release; slides); the Zepbound US label has been updated to include SURMOUNT-3 and -4 data (view label); and Sanofi hosted its Q3 ’24 earnings call (press release; slides; infographic). Below, FENIX provides highlights and insights for the respective news items.

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Lilly initiates Bimagrumab+Tirzepatide trial; Lexicon and Viatris Partner for Sotagliflozin Commercialization; Gan & Lee T2DM Assets Meet Primary Endpoints; Lipocine Virtual KOL Event; Noom Adds Body Composition to App

A series of cardiometabolic-related news items have been observed from Lilly, Lexicon Pharmaceuticals, Viatris, Gan & Lee Pharmaceuticals, Lipocine, and Noom. Below, FENIX provides highlights and insights for the respective news items.

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Adocia Patents Semaglutide + Cagrilintide Combination; Seraxis Receives IND for Islet Cell Study; Upcoming AASLD 2024 Presentations

Three cardiometabolic-related news items have been observed: Adocia announced it filed patents for stable formulations of hormone combinations for obesity and T2DM, including a semaglutide + cagrilintide combination (view press release); Seraxis announced FDA approved its IND application for a Ph1/2 study of SR-02, an islet replacement therapy (view press release); and 89Bio, Galectin Therapeutics, and Aligos Therapeutics announced upcoming data presentations at AASLD 2024 (view 89Bio press release; view Galectin press release; view Aligos press release). Below, FENIX provides highlights and insights for the respective news items.

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FDA Tirzepatide Shortage Removal Update; Catalent Sells Site to Ardena; LifeVantage Launches MindBody GLP-1 System; Inventiva Receives Additional Funding for MASH; October CHMP Agenda; Sagimet Publishes FASCINATE-2 Data; Q Bio Appoints Jeff Brewer as CEO

A series of cardiometabolic-related news items have been observed from FDA, Catalent/Ardena, LifeVantage Corporation, Inventiva, EMEA, Sagimet Biosciences, and Q Bio. Below, FENIX provides highlights and insights for the respective news items.

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Senator Warren Calls for Novo/Catalent Block; Lilly Sends Cease-And-Desist to Compounding Pharmacies; Lilly and KeyBioscience Continue Obesity Collaboration

Three cardiometabolic-related news items have been observed: Senator Warren sent a letter to FTC to block Novo’s Catalent acquisition (view letter); Lilly sent cease-and-desist letters to compounding pharmacies to stop the sale and manufacture of non-branded tirzepatide (view article); and Lilly and KeyBioscience announced the extension of their DACRA development collaboration in obesity (view press release). Below, FENIX provides highlights and insights for the respective news items.

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BI Receives BTD for Survodutide and Initiates 2 Ph3 MASH Trials; Roche Ph2 CT-388 Trial in Obesity+T2DM; Drug Compounder Group Sues FDA; WeightWatchers to Offer Compounded Semaglutide; Novo Invests $158M in Insulin Plant

A series of cardiometabolic-related news items have been observed from Boehringer Ingelheim, Roche, the Outsourcing Facilities Association, WeightWatchers, and Novo Nordisk. Below, FENIX provides highlights and insights for the respective news items.

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FDA Removes Tirzepatide from Shortage List

FDA announced the tirzepatide shortage has been resolved and provided clarifications for compounding manufacturers. According to the announcement, FDA confirmed with Lilly that their stated product availability and manufacturing capacity can meet the present and projected national demand. However, patients and prescribers may still see intermittent localized supply disruptions as the products move through the supply chain from Lilly and distributors to local pharmacies. Below, FENIX provides brief insight into the impact of the FDA announcement.

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