Tag Archives: Lilly

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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Lilly/Thrive Partnership for LillyDirect; Verdiva Lauches as Obesity Company; Senseonics Business Updates

Three cardiometabolic-related news items have been observed: Lilly and Thrive Global announced a partnership to implement healthy behaviors on LillyDirect (view press release); Verdiva Bio announced its launch as a cardiometabolic company (view press release); and Senseonics released its YE 2024 business update (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.

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.

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 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.

CHMP Denies Mounjaro OSA Indication; FLOW Positive CHMP Opinion; New Oramed Oral Insulin Study; Diamyd and FDA Align on Accelerated Approval; Noom to Offer Metformin for Weight Loss

A series of cardiometabolic-related news items have been observed from CHMP, Oramed, Diamyd Medical, and Noom. 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/EASD 2025 Guidelines; Ro/Lilly Zepbound SDV Partnership; Tirzepatide for Addiction Treatment

Three cardiometabolic-related news items have been observed: Updated ADA/EASD guidelines for 2025 have been released (view guidelines; view revisions); Lilly and Ro partnered for Zepbound single-dose vials (view press release); and Lilly announced potential plans for tirzepatide for treatment of addiction and inflammation (view article; view interview). 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.

EC Approves Novo/Catalent Deal; Novo Cuts Insulin Business; Twiist AID Webinar; New Pfizer and Novo Obesity Studies; Lilly CDMO Agreement

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Sequel Med Tech, Pfizer, and Lilly. 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.