Tag Archives: FDA

FDA Commissioner Comments on T1DM at BIO Conference; Lilly Acquires Verve Therapeutics; Metsera Ph1/2 Amylin Trial; Medtronic Invests in India; Allurion Shares Data at ASMBS

A series of cardiometabolic-related news has been observed from FDA, Lilly/Verve, Metsera, Medtronic/MiniMed, and Allurion Technologies. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.

Already a member? Log in here

Novo London, Zealand, MannKind, Xeris, and Viatris Q1 ‘25 Earnings; US Judge Supports FDA’s Removal of Lilly’s GLP-1RA From Shortage List; Lilly Makes Changes to Executive Leadership

A series of cardiometabolic-related news items has been observed from Novo Nordisk, Zealand Pharma, FDA/OFA, Lilly, MannKind, Xeris, and Viatris. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.

Already a member? Log in here

Medtronic Seeks Interoperability; Roche, Viking, Sanofi, and Merck Q1 ‘25 Earnings; Zealand Enrolls First Patient in Ph2 T2DM Study; Esperion R&D Day 2025

A series of cardiometabolic-related news items has been observed by Medtronic, Roche, Viking Therapeutics, Zealand Pharma, Sanofi, Merck, and Esperion. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.

Already a member? Log in here

Novo Files HD Oral Sema; Roche Expands US Manufacturing; MetaVia Additional Ph1 Obesity Results; Ypsomed Sells Diabetes Care Business; Biolinq $100M Series C; April CHMP Agenda

A series of cardiometabolic-related news items has been observed from Novo Nordisk, Roche, MetaVia, Ypsomed, Biolinq, and EMA. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.

Already a member? Log in here

Bayer’s Finerenone Under Priority Review; Dexcom Receives FDA Warning; Zealand Completes Petrelintide Ph2b Enrollment; vTv Announces Clinical Hold Lift; Entera/OPKO Advance Oral AOM to Clinic

A series of cardiometabolic-related news items has been observed from Bayer, Dexcom, Zealand Pharma, vTv Therapeutics, and Entera Bio/OPKO Health. Below, FENIX provides highlights and insight for the respective news items.

This content is for members only.

Already a member? Log in here

Obesity Compounders Take a Hit; Viking Signs Manufacturing Deal; Roche Hires Novo Exec; Halia Receives Novo’s Golden Ticket

A series of cardiometabolic-related events has been observed from FDA, Viking Therapeutics, Roche, and Halia Therapeutics/Novo Nordisk. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.

Already a member? Log in here

Tandem, Altimmune, MannKind, Silence, and Viatris Q4 ’24 Earnings; Zevra Sells PRV; TIXiMED Ph1 TIX100 Trial Update

A series of cardiometabolic-related news items have been observed from Tandem Diabetes Care, Altimmune, Zevra Therapeutics, TIXiMED, MannKind, Silence Therapeutics, and Viatris. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.

Already a member? Log in here

Sema Shortage Resolved; Pfizer/Viking M&A Rumor; Insulet Q4 ’24 Earnings

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Viking Therapeutics/Pfizer, and Insulet. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.

Already a member? Log in here

FDA Issues Warning Letter to Compounder; Lilly Discontinues HFpEF and CKD Asset; Teva Q4 ’24 Earnings

Three cardiometabolic-related news items have been observed: FDA issued a warning letter to a compounding facility over issues with its GLP-1RA production (view letter); Lilly has reportedly discontinued the development of volenrelaxin for HF and CKD (view article); and Teva Pharmaceuticals hosted its Q4 ’24 earnings (press release; slides). Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.

Already a member? Log in here

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.

This content is for Read Less members only.

Already a member? Log in here