Category Archives: Bolus Insulin

FDA Draft AOM Guidance; Novo/Valo Expand Partnership; Viking Initiates Oral VK2735 Ph2 Trial; Glooko/Hedia Integration; Sana Islet Cell Therapy T1DM Success; Found Expands to Dissolvable Oral Semaglutide

A series of cardiometabolic-related news items have been observed from FDA, Novo Nordisk/Valo Health, Viking Therapeutics, Glooko/Hedia, Sana Biotechnology, and Found. Below, FENIX provides highlights and insights into the respective news items.

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December CHMP Agenda; Senseonics Eversense 365 Launch Updates; BioAge Discontinues Ph2 Obesity Trial

Three cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (Dec 9-12) has been released (view here); Senseonics announced commercial updates to its Eversense 365 launch (view press release); and BioAge announced the discontinuation of its Ph2 obesity trial (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Metsera Initiates Ph2b MET-097 Obesity Trial; Arrowhead Files for Ph1/2a Obesity Trial Initiation; Sanofi Invests in New Beijing Insulin Plant

Three cardiometabolic-related news items have been observed: Metsera initiated a Ph2b MET-097 (SC GLP-1RA) obesity trial (view CT.gov record); Arrowhead Pharmaceuticals filed for regulatory clearance to initiate a Ph1/2a ARO-ALK7 (RNAi) obesity trial (view press release); and Sanofi announced it invested €1B ($1.05B) for a new insulin manufacturing facility in Beijing (view article; view Chinese press release). Below, FENIX provides highlights and insights for the respective news items.

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November CHMP Agenda

The CHMP agenda (view here) for this month’s meeting (Nov 11-14) has been released and includes several cardiometabolic-related agenda items. Below, FENIX provides highlights and insights for the agenda.

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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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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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EASD 2024 Key Press Releases (Sep 10)

On the second day of EASD 2024, 8 key news items were observed from Lilly, Novo Nordisk, Abvance Therapeutics, Scholar Rock, Altimmune, Arrowhead Pharmaceuticals, Bayer, and Lexicon. The following topics are covered below (hyperlinks to external items):

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