Tag Archives: tirzepatide

Ypsomed Signs Long-Term Autoinjector Supply Deal with Novo; Lilly Files Lawsuits Over Copycat Mounjaro Products

Two cardiometabolic-related news items have been observed: Ypsomed announced it has signed a long-term supply agreement with Novo Nordisk to manufacture autoinjectors for various metabolic drugs currently undergoing clinical trials (view press release); and Lilly has recently sued 10 medical spas, wellness centers, and compounding pharmacies for selling unapproved and compounded versions of tirzepatide (view article). Below, FENIX provides highlights and insights into 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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Lilly Initiates New Ph2 Study Investigating High Doses of Tirzepatide in Patients with T2DM and Obesity; Gan & Lee Doses First Patient in Ph2 QW Insulin Study; BMS discontinues NASH asset

Three cardiometabolic-related news items have been observed: Lilly initiated a Ph2 study to investigate high doses of tirzepatide in patients with T2DM and obesity that are on metformin (view CT.gov record); Gan & Lee announced the first subject has been dosed in its Ph2 study evaluating QW insulin, GZR4, in 130 Chinese adult subjects with T2DM (view press release); and BMS disclosed it is terminating its program evaluating HSP47 in NASH during its R&D day (view article). Below, FENIX provides highlights and insights into 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

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Lilly Up Big Following Q2 ’23 Results and SELECT Data Readout

Lilly hosted its Q2 ’23 earnings call (press release; slides) and provided updates across its CVRM portfolio. Of note, Mounjaro led Lilly’s new products category with WW Q2 ’23 sales reaching nearly $1B. Following the Q2 ’23 beat, increased FY 2023 guidance, and bolstered by Novo’s SELECT readout (previous FENIX insight), Lilly’s stock jumped +15% to an all-time high of ~$521/share. Unsurprisingly, Lilly also provided commentary surrounding the SELECT data readout. Below, FENIX provides highlights and insight from the call, including additional thoughts on the evolving obesity CVOT dynamic.

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 Completes Tirzepatide Obesity Trials; Teladoc, Viking, and Roche Q2 ‘23 Earnings

Four cardiometabolic-related news items have been observed: Lilly announced topline results from SURMOUNT-3 and SURMOUNT-4, demonstrating up to 26.6% mean weight loss (view press release); Teladoc Health (press release; slides), Viking Therapeutics (press release), and Roche (press release; slides) hosted their respective Q2 ‘23 earnings calls. Below, FENIX provides highlights and insights into 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.

NICE Requests Additional Tirzepatide T2DM Data; Insulet Initiates Omnipod 5 + Libre 2 Study; Esperion Files CLEAR Outcomes in EU; Nemaura Expands proBEAT Pilot; NeuroBo and Terns Announce Preclinical Obesity Data

A series of cardiometabolic news items have been observed from NICE, Insulet, Esperion, Nemaura, NeuroBo, and Terns. 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 2023 Key Press Releases (June 24)

On the second day of ADA 2023, ten cardiometabolic-related news items were observed from Lilly, Zealand, BI, Novo Nordisk, Biomea Fusion, Sciwind Biosciences, Medtronic, Vertex, and Esperion. Below, FENIX provides context and analysis for the announcements.

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 to Use PRV for Tirzepatide Obesity Submission Following Positive SURMOUNT-2 Topline Results; Lilly, Viking, and Teladoc Q1 ’23 Earnings

Four cardiometabolic-related news items have been observed: Lilly announced tirzepatide’s SURMOUNT-2 trial showed -15.7% weight loss in obese adults and said it will use a PRV for an obesity PDUFA date by YE 2023 (view press release); and Lilly (press release; slides), Viking Therapeutics (press release) and Teladoc Health (view press release; slides) hosted their respective Q1 ’23 earnings calls. Below, FENIX provides highlights and insights into 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 Initiates SURMOUNT H2H Obesity Trial vs. Wegovy; Lannett Delisted from NYSE; Novo Initiates Ph3 Icodec ONWARDS 9 CGM Trial; Senate Targets PBMs

A series of cardiometabolic-related news items have been observed: Lilly has initiated a fifth trial in the Ph3 SURMOUNT obesity program evaluating tirzepatide vs. Wegovy in non-T2DM obese patients (SURMOUNT-5; view CT.gov record); Lannett announced NYSE has commenced proceedings to delist its common stock (view press release); Novo Nordisk has initiated a Ph3 trial evaluating flash glucose monitoring based titration of QW insulin icodec in insulin-naïve T2DM participants (ONWARDS 9; view CT.gov record); the Senate Finance Committee has released a framework to target PBMs and reduce drug costs for patients and taxpayers (view here); and Senator Bernie Sanders’s team announced that the Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing on Wednesday, May 10, at 1:00 PM EST where the CEOs of Lilly, Novo, Sanofi, and senior executives from major PBMs will testify (view article). Below, FENIX provides highlights and insights into 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 Completes SURMOUNT-2 Trial; FDA Clears Libre 3 Reader; Novo Initiates Ph3 Icodec + Semaglutide Treatment Intensification Trial

Three cardiometabolic-related news items have been observed: On April 13, 2023, the ClinicalTrials.gov record for SURMOUNT-2 was updated to reflect that the trial has been completed; Abbott announced FDA cleared a standalone reader for its FreeStyle Libre 3 iCGM system (view press release); and Novo Nordisk has initiated a Ph3 T2DM trial evaluating icodec as add-on therapy to semaglutide for treatment intensification (view CT.gov record). Below, FENIX provides highlights and insights into 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.

New Tirzepatide Injection Device Trial; Novo Partners with Aspect Biosystems; Sanofi’s Provention Bio Acquisition Regulatory Issue; Glooko Partners with Hedia

Four cardiometabolic-related news items have been observed: Lilly initiated a Ph1 tirzepatide trial evaluating a new injection device (view CT.gov record); Novo Nordisk and Aspect Biosystems announced a collaboration, development, and license agreement to develop bioprinted tissue therapeutics for diabetes and obesity (view press release); Sanofi announced it has withdrawn and refiled its Premerger Notification and Report Form under the Hart-Scott-Rodino Act of 1976 (HSR Act) for its pending acquisition of Provention Bio (view press release); and Glooko announced a new global partnership with Hedia (view press release). Below, FENIX provides highlights and insights into the respective news items including thoughts on Lilly’s potential new injection device. 

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.