Tag Archives: Zepbound

Zepbound Supply Constraints Observed; NeuroBo Completes Ph2a MASH Trial Enrollment; Galectin Q4 ’23 Earnings

Three cardiometabolic-related news items have been observed: Lilly’s Zepbound is reportedly facing supply constraints in the US (view article); NeuroBo announced it completed enrollment of Part 1 of the Ph2a trial evaluating DA-1241 (GPR119 agonist) for the treatment of MASH (view press release); and Galectin recently reported its Q4 ’23 earnings (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.

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Wegovy SELECT Label Analysis; CMS Opens Obesity Coverage

FDA recently approved the Wegovy label expansion to reduce the risk of MACE in adults with either overweight or obesity and established CVD (view updated Wegovy label; previous FENIX insight). The label expansion is based on the SELECT CVOT which demonstrated a -20% RRR in 3P-MACE for non-T2DM people with established CVD who were treated with QW 2.4mg injectable semaglutide (previous FENIX insight). Following the approval, Medicare has issued guidance to Part D plans stating anti-obesity drugs also treating medically accepted indications should be reimbursed (view article). Below, FENIX has conducted a Wegovy label analysis, including insight into the impact of the recent CMS decision.

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.

Awiqli (QW Insulin Icodec) Receives Positive CHMP Opinion; Oprah TV Special Spotlights Zepbound and Wegovy

Two cardiometabolic-related news items have been observed: CHMP adopted a positive opinion, recommending marketing authorization for “Awiqli” (QW insulin icodec) for the treatment of diabetes in adults (view press release); and Oprah hosted a show on ABC titled, “Shame, Blame, and the Weight Loss Revolution” which addressed the stigma associated with obesity and the success of GLP-1RAs (view article; watch episode on HULU). Below, FENIX provides highlights and insights for the respective news items, including brief thoughts on the social media hype following Oprah’s TV special.

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.

CBO Hints at Medicare Coverage for Obesity Drugs; AZ Initiates Ph3 Balcinrenone/Dapa Trial

Two cardiometabolic-related news items have been observed: The CBO has hinted at potential Medicare coverage for obesity drugs, such as Wegovy and Zepbound (view article); and AZ initiated a Ph3 balcinrenone+dapa trial in HF and impaired kidney function (view CT.gov record). Below, FENIX provides highlights and insights from 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.

Ionis Ph2 MASH Results; New BI Ph3 Survodutide MASH Trial; Silence Ph2 Lp(a) Results; Lilly Partners with Amazon Pharmacy; Arecor Partners for Oral GLP-1RA; Ascensia Expands PSP

A series of cardiometabolic-related news items have been observed from Ionis Pharmaceuticals, Boehringer Ingelheim, Silence Therapeutics, Lilly, Arecor Therapeutics, and Ascensia Diabetes Care. 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.

ATTD 2024 Key Press Releases Day 2 & 3 (March 7 & 8); Xeris Q4 ’23 Earnings Update

On the second and third day of ATTD 2024, six cardiometabolic-related news items were observed from Lilly, Regeneron, Akero, Insulet, and Xeris. Below, FENIX provides highlights and insight 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.

ATTD 2024 Key Press Releases Day 1 (March 6)

On the first day of ATTD 2024, seven cardiometabolic-related news items were observed from Roche, Dexcom, Abbott, Lilly, Know Labs, Akero, and Biomea Fusion. 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.

Mounjaro and Zepbound Launch Updates; Tirzepatide Ph2 MASH Data; Lilly’s Smart Insulin Enters Ph1; Lilly Q4 ’23 Earnings Update

Lilly hosted its Q4 ’23 earnings call (press release; slides) and provided updates across its CVRM portfolio. Of note, the company announced topline tirzepatide Ph2 SYNERGY-NASH data, discussed Zepbound launch updates, provided insight into manufacturing capacity increases, and disclosed its glucose-responsive insulin has entered clinical development, among other pipeline updates. Below, FENIX provides highlights and insights from the 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.

JPM 2024 Day 2: ABT, PODD, NVO, LLY, AZN, BAY, BMF, TDOC; Embecta Files 510(k) for T2DM Patch Pump; Omada Partners with Amazon for Cardiometabolic Programs

On the second day of JPM 2024, FENIX has provided coverage of presentations by major CVRM companies, including Abbott, Insulet, Novo Nordisk, Lilly, AZ, Bayer, Biomea, and Teladoc. GSK and Sanofi also presented at JPM 2024 but had no meaningful discussion relating to their respective CVRM portfolios. Separately, two CVRM-related news items have been observed: Embecta announced it submitted a 510(k) filing to FDA for its open-loop patch pump for T2DM (view press release); and Omada Health announced a partnership with Amazon’s Health Condition Programs for its cardiometabolic programs (view press release).

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 Restructures Diabetes Business; Novo Partners for Obesity and MASH; BI Partners with Ribo for MASH; Lilly Issues Open Letter on Off-Label Mounjaro/Zepbound Use; Lilly Launches Diabetes/Obesity Digital Health Program; Evaluate Projects Novo and Lilly to Top 2024 Global New Sales

A series of cardiometabolic-related news items have been observed from Roche, Novo, Lilly, BI, and Evaluate. 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.