Tag Archives: tirzepatide

Zepbound OSA Label and Website Analysis

FDA recently approved the Zepbound label expansion to treat moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity (view label; previous FENIX insight). The label expansion is based on Lilly’s Ph3 SURMOUNT-OSA trial evaluating tirzepatide in participants with OSA and obesity (view publication; previous FENIX insight). Below, FENIX has conducted an analysis of the updated Zepbound label and patient/HCP/employer websites.

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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OFA Responds to Novo’s Petition on Semaglutide Compounding; PreEvnt Announces New Non-Invasive Glucose Monitor; Novo Holdings and Lilly Invest in Orbis Series A Financing

Three cardiometabolic-related news items have been observed: The Outsourcing Facilities Association (OFA) responded to Novo’s petition to add semaglutide to FDA’s Demonstrable Difficulties for Compounding Lists (DDC Lists; view document); PreEvnt announced a new non-invasive glucose monitor that uses the patient’s breath (view press release); and Novo Holdings and Lilly participated in Orbis Medicines’s €90M Series A financing for oral macrocycle drugs (view Orbis press release; view Novo Holdings 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.

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Purchase Blast$599.00

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

Lilly Requests to Join Compounding Lawsuit; 2026 Medicare/Medicaid Obesity Proposal; Novo Petitions FDA For Compounding

Three cardiometabolic-related news items have been observed: Lilly requested to join tirzepatide compounding lawsuit (view article); CMS and HHS released the 2026 policy and technical changes to the Medicare/Medicaid programs and included proposed guidance for anti-obesity medications (view document); and Novo Nordisk has continued to petition FDA to stop compounding of Victoza (view article). 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.

Holiday Hangover: FDA Approves Zepbound for OSA; NICE Finalizes Tirzepatide Guidelines; Abbott and Dexcom Reach Agreement; Arrowhead Ph1/2a ARO-INHBE Trial in Obesity; AZ Initiates Ph2 MASH Trial; Zealand Petrelintide Commentary; Generic Liraglutide Approvals; Lexicon Receives CRL for Zynquista

During the holiday break, a series of cardiometabolic-related news items were observed from Lilly, NICE, Dexcom/Abbott, Arrowhead Pharmaceuticals, AstraZeneca, Zealand Pharma, Biocon/Hakima, and Lexicon 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.

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.

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.

Novo/Catalent Deal Approval; Novo Invests in New Manufacturing Facility; Afrezza Pediatric Results; New Ph2 Quad-Agonist + Tirzepatide Trial

A series of cardiometabolic-related news items have been observed from Novo Nordisk, MannKind, and Biomed Industries. 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.

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.

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.

UK Tirzepatide Rollout Plan; Lilly and Amgen Expand Manufacturing Facilities; New Novo GLP-1/GIP RA CKD and Obesity Trials; Insulet Defends US Patent from EOFlow

A series of cardiometabolic-related news items have been observed from NICE, Lilly, Amgen, Novo Nordisk, and Insulet. 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 Releases HFpEF and Lp(a) Data; Inventiva and Sagimet MASH Data at AASLD; New Abbott Manufacturing Facility; NeuroBo Name Change

A series of cardiometabolic-related news items have been observed from Lilly, Inventiva, Sagimet Biosciences, Abbott, and NeuroBo 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.

Tirzepatide Full Surmount-1 Three-Year Results; Novo to Discontinue Human Insulin Pens; Hims & Hers Launches GLP-1RA Shortage Tracker; Skye Enrollment Update

A series of cardiometabolic-related news items have been observed from Lilly, Novo Nordisk, Hims & Hers, and Skye Bioscience. 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.