Tag Archives: FDA

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

FDA Releases Status on GLP-1RA Supply; AZ Initiates Baxdrostat/Dapa Trial in CKD and CV; TIXiMED Announces $2.65M Investment

Three cardiometabolic-related news items have been observed: FDA clarified the tirzepatide shortage resolution and impact on compounding pharmacies (view report); AstraZeneca initiated a Ph3 baxdrostat/dapagliflozin renal outcomes and CV mortality trial (view CT.gov record); and TIXiMED announced a $2.65M Helmsley Charitable Trust investment (view press release). 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

Zynquista Negative Adcom Vote; Novo STEP-9 Results Published; Wegovy Removed from FDA Shortage List; Amgen, Madrigal, Biomea, Teladoc, and Amarin Q3 ’24 Earnings; BI/Gubra Discontinue NPY2 for Obesity; Inventiva Positive DMC Recommendation for Ph3 MASH Trial

A series of cardiometabolic-related news items have been observed from Lexicon, Novo Nordisk, Amgen, Madrigal, Biomea Fusion, BI/Gubra, Inventiva, Teladoc, and Amarin. 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

QW Icodec CRL Information; Beta Bionics Launches Libre 3+ Integration; O5 iOS App US Launch; Zealand Obesity Trial

A series of cardiometabolic-related news items have been observed from FDA/Novo Nordisk, Beta Bionics, Insulet, and Zealand Pharma. 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