Tag Archives: semaglutide

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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ITCA 650 Faces Uphill Battle as FDA Releases Adcom Briefing Docs; Novo Receives Form 483 Observations; Abbott and WeightWatchers Launch Connected App Experience

Three cardiometabolic-related news items have been observed: FDA posted briefing documents (view here) for its upcoming ITCA 650 adcom which is scheduled for September 21, 2023; FDA reportedly issued a Form 483 following an inspection of Novo Nordisk’s plant in Clayton, North Carolina (view article); and Abbott and WeightWatchers announced the availability of a connected app that allows PWD to access data from their Libre 2 within their WeightWatchers app (view press release). Below, FENIX provides highlights and insights into the respective news items, including thoughts on the potential outcome of the ITCA 650 adcom.

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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Novo and Lilly Win Again with Positive STEP HFpEF Full Results

Novo Nordisk announced positive full results from the Ph3 STEP HFpEF trial (view CT.gov record) demonstrating QW semaglutide 2.4mg led to reductions in HF-related symptoms, reductions in physical limitations, and improvements in exercise functions vs. placebo. The full results were presented at the ESC 2023 (August 25-28) conference in Amsterdam, Netherlands, and simultaneously published in the NEJM (view publication). Importantly, Novo stated it anticipates filing for the Wegovy label update in H1 2024 following the completion of STEP HFpEF-DM (view CT.gov record) in participants with HFpEF and obesity with T2DM in Q4 2023. Below, FENIX provides an overview of the STEP HFpEF results as well as thoughts on the impact to the HFpEF treatment paradigm, including potential readthrough to Lilly and other manufacturers looking to enter the obesity market.

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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Novo and Lilly Win with Positive SELECT CVOT Topline Results

Novo Nordisk announced positive topline results from the SELECT CVOT (view CT.gov record) demonstrating a 20% RRR in 3P-MACE for non-T2DM people with established CVD who were treated with QW 2.4mg semaglutide (Wegovy) compared to placebo. Following the news, Novo’s stock price increased +16%. Novo is anticipated to provide further commentary during its Q2 ’23 earnings call on Thursday, August 10, 2023, at 7:00 AM EST. Below, FENIX provides initial thoughts on the SELECT results, including potential readthrough to Lilly and other manufacturers looking to enter the obesity market.

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’s GLP-1RA Drugs Under EMA Review; Novartis’s Entresto Patent Ruled Invalid; FDA Approves Expanded Indication for Leqvio; Tonix Initiates Ph2 Intranasal TNX-1900 Study for Pediatric Obesity

Four cardiometabolic-related news items have been observed: Novo Nordisk’s diabetes and obesity drugs, Ozempic/Wegovy (semaglutide) and Saxenda (liraglutide), are under EMA review following two cases of suicidal ideation and one case of self-harm from users in Iceland (view article); Novartis announced the U.S. District Court for the District of Delaware ruled the patent covering Entresto and combinations of sacubitril and valsartan is invalid (view press release); Novartis also announced FDA approved a label update for Leqvio (inclisiran) to enable earlier use in patients with elevated LDL-C, as an adjunct to diet and statin therapy for patients who have not had a CV event but are at an increased risk for heart disease (view press release); and Tonix Pharmaceuticals announced the first participant has been enrolled in its Ph2 POWER study of TNX-1900, an intranasal potentiated oxytocin, for the treatment of pediatric obesity (view press release; 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.

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Purchase Blast$599.00

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STEP HFpEF Topline Results; Novo ADA 2023 Investor Event

Novo Nordisk hosted an investor event during ADA 2023 (view slides) and also raised its FY 2023 financial guidance to 24-30%. During the call, Novo provided an overview of the QW insulin icodec Ph3 program and value proposition, insight into the Ph3 cagrisema T2DM program, high-dose oral semaglutide in T2DM and obesity, and topline STEP-HFpEF results. Of note, management briefly mentioned that SELECT CVOT data will be presented in the near future. Below, FENIX provides highlights and insights from the Novo ADA 2023 investor event.

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 Files Lawsuit Over Third-Party Semaglutide Promotion; Versanis Bio Completes Enrollment of Ph2b Bimagrumab Study in Obesity; FDA Approves Jardiance and Synjardy for Pediatric T2DM and Lodoco for ASCVD

Four cardiometabolic-related news items have been observed: Novo Nordisk announced it is taking legal actions over third-party semaglutide promotion (view press release); Versanis Bio announced it completed enrollment for the global Ph2b BELIEVE study evaluating the safety and efficacy of bimagrumab as a monotherapy and in combination with semaglutide in participants with obesity (view CT.gov record); FDA approved Jardiance and Synjardy to improve glycemic control in children 10 years of age and older with T2DM (view press release) as well as Agepha Pharma’s Lodoco in adult patients with established ASCVD or with multiple risk factors for cardiovascular disease (view press release). Below, FENIX provides highlights and insights into the respective news items, including brief thoughts on the bimagrumab + semaglutide program. 

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 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.

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Purchase Blast$599.00

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

Wegovy and Entresto Receive Positive CHMP Opinions for Pediatric Indication Extensions

Two cardiometabolic-related news items have been observed: Novo’s Wegovy (semaglutide) received a positive CHMP opinion to extend the weight management indication to include treatment of adolescents aged 12-18 years (view March CHMP meeting highlights); and Novartis announced that CHMP has adopted a positive opinion recommending the approval of Entresto (sacubitril/valsartan) for the treatment of symptomatic HF with left ventricular systolic dysfunction in pediatric patients aged 1 to <18 years (view press release). 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

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

Positive High-Dose Oral Semaglutide Topline Results

Novo Nordisk announced positive topline results from the PIONEER PLUS trial (view CT.gov record) evaluating high-dose oral semaglutide (25mg and 50mg). Interestingly, Novo stated it anticipates filing the 25mg and 50mg oral semaglutide doses for regulatory approval in the US and EU in 2023 although the “global roll-out of the 25mg and 50mg doses is contingent on portfolio prioritizations and manufacturing capacity.” Below, FENIX provides an overview of the high-dose Rybelsus data as well as insight into Novo’s decision for launching the additional doses.

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.