Tag Archives: semaglutide

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

Novo Initiates Ph1 Study for New Obesity Asset; Lemonaid GLP-1RA and Compounded Semaglutide Program; New Semaglutide HF Analysis Published; Alnylam’s Ph3 ATTR-CM Vutrisiran Data

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Lemonaid Health, and Alnylam Pharmaceuticals. Below, FENIX provides highlights and insights for the respective news items. 

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Lilly Launches Single-Dose Zepbound Vials; Omnipod 5 T2DM Approval; Novo Semaglutide Adolescent Obesity Study

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

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

STEP HFpEF Withdrawn; QM GLP/GIP Withdrawn; Novo Q2 ’24 Earnings

Novo Nordisk hosted its Q2 ’24 earnings call (press release; slides) and provided updates across its CVRM portfolio. Importantly, Novo disclosed it has withdrawn the STEP HFpEF sNDA and it discontinued development of its QM GLP/GIP dual agonist, among other updates. FENIX will cover Novo’s London Q2 ’24 earnings call tomorrow, August 8, 2024. Below, FENIX provides highlights and insights from the Q2 ’24 earnings call.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Kerendia FINEARTS-HF Topline Results; Simplera CGM Approved by FDA; Novo Initiates Second Ph3 H2H Cagrisema vs. Tirzepatide T2DM Study; Ypsomed and MTD Complete BGM Business Sale

A series of cardiometabolic-related news items have been observed from Bayer, Medtronic, Novo Nordisk, and Ypsomed. Below, FENIX provides highlights and insights for the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Roche CGM Receives CE Mark; Lilly Beats Novo in GLP-1RA Observational Study; Pfizer Leadership Change; FTC Releases Prescription Drug Middlemen Interim Staff Report

A series of cardiometabolic-related news items have been observed from Roche, Lilly, Pfizer, and the FTC. Below, FENIX provides highlights and insights for the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

ADA 2024 Key Press Releases (June 24)

On the final day of the ADA 2024 conference, nine cardiometabolic-related news items have been observed from Novo Nordisk, Adipo Therapeutics, Trinity Biotech, Alnylam, Viking, Teva, Teladoc Health, and CHMP. Below, FENIX provides context and analysis for the announcements, including thoughts on the potential FLOW label.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Full FLOW Results at ERA; Lilly Increases Manufacturing Investment to $9B

Two cardiometabolic-related news items have been observed: the full FLOW results were presented at ERA 2024 and simultaneously published in the NEJM (press release); and Lilly announced it increased its manufacturing investment for tirzepatide API production (press release). Below, FENIX provides highlights and insights for the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Fractyl Preclinical Rejuva Obesity Data; Hims and Hers to Sell Compounded Semaglutide; Sanofi T1DM Screening Campaign

Three cardiometabolic-related news items have been observed: Fractyl Health presented preclinical Rejuva obesity data at DDW 2024 (view press release); Hims & Hers Health added compounded semaglutide to its virtual weight management program (view article); and Sanofi has launched a T1DM screening campaign titled, “Take the 1 Pledge,” featuring celebrity spokespeople (view website). Below, FENIX provides highlights and insights for the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.