Category Archives: Other

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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AZ Lp(a) Licensing Deal; Novo Reaches Semaglutide Patent Settlement with Viatris; Trinity Completes Pre-Pivotal CGM Trial

Three cardiometabolic-related news items have been observed: AstraZeneca announced a licensing deal with CSPC Pharmaceutical Group for a preclinical oral Lp(a) disruptor (view press release); Novo Nordisk and Viatris have settled a lawsuit over one of Novo’s semaglutide patents (view article); and Trinity Biotech announced the completion of its EU pre-pivotal CGM trial (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Elevai Files Patents For Obesity Lean Mass Preservation; Medtronic Pump Recall

Two cardiometabolic-related news items have been observed: Elevai Biosciences announced it filed two patent applications for EL-22 (oral myostatin engineered probiotic) as a monotherapy or combination with GLP-1RAs (view press release); and Medtronic announced a voluntary recall of its MiniMed 600/700 series insulin pumps due to shortened battery life issues (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Eversense 365 Launched in US; Kailera Launches as Obesity Biotech; Lilly Funds New $4.5B Indiana Facility

Three cardiometabolic-related news items have been observed: Ascensia Diabetes Care announced the launch of the Eversense 365 CGM in the US (view press release); Kailera Therapeutics announced its launch as a biotech with an asset in Ph3 development for the treatment of obesity (view press release; view article); and Lilly announced a $4.5B investment to create a new R&D and manufacturing facility in Lebanon, Indiana (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Metsera Partners with Amneal for Obesity Manufacturing; Rivus Obesity Data at HFSA 2024; Sagimet Receives BTD for Denifanstat; Biomea Establishes Scientific Advisory Board; Madrigal Appoints New SVP

A series of cardiometabolic-related news items have been observed from Metsera/Amneal Pharmaceuticals, Rivus Pharmaceuticals, Sagimet Biosciences, Biomea Fusion, and Madrigal Pharmaceuticals. Below, FENIX provides highlights and insights for the respective news items.

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FDA Lifts BMF-219 Clinical Hold; Abvance ABV 101 Virtual KOL Event

Two cardiometabolic-related news items have been observed: FDA lifted the clinical hold on Biomea Fusion’s clinical trials of BMF-219 in T2DM and T1DM (view press release; view webcast); and Abvance Therapeutics hosted a virtual KOL event for its ABV 101 asset (view webcast). Below, FENIX provides highlights and insights for the respective news items. 

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