Tag Archives: Ozempic

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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Novo Nordisk, Tandem, Alnylam, and Regeneron Q1 ’23 Earnings

Four cardiometabolic-related news items have been observed: Novo Nordisk (view press release; slides), Tandem Diabetes Care (view press release), Alnylam Pharmaceuticals (view press release; slides), and Regeneron (view press release; slides) hosted their respective Q1 ’23 earnings calls and provided CVRM-related updates. Below, FENIX provides highlights and insights from the earnings calls.

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 Raises 2023 Guidance; Sana Biotechnology Appoints New R&D Leaders and Announces Publication of Pre-Clinical Data

Two cardiometabolic-related news items have been observed: Novo Nordisk announced its full-year sales and operating profit outlook has been raised for 2023 (view press release); and Sana Biotechnology announced the appointment of Douglas E. Williams, as President of R&D, and Gary Meininger, MD, as CMO, of its R&D organization (view press release). Separately, Sana announced the publication of pre-clinical data for its hypoimmune pancreatic islet cells in Science and Translational Medicine (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.

Sanofi Acquires Provention Bio; Ozempic Takes Stage at Oscars

Two CVRM-related news items have been observed: Sanofi and Provention have entered a $2.9B acquisition deal (press release); and Ozempic takes center stage at the 2022 Oscar awards show (view article). Below, FENIX provides highlights and insights from the news items, including thoughts on how the Provention Bio acquisition fits into Sanofi’s diabetes strategy.

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 Nordisk Q4 ’22 Earnings Update

Novo Nordisk hosted its Q4 ’22 earnings call (press release; slides) and provided updates across its business, including Wegovy/Ozempic supply, GLP-1RA market dynamics, new QW insulin icodec data, and more. 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.

Abbott Q4 ’22 Earnings; Tidepool Loop Receives FDA Clearance; Lilly to Expand Incretin Manufacturing Capacity; Novo Receives Marketing Practices Complaint; AGC Biologics to Manufacture Tzield; Nemaura Reports Positive Miboko Data; J&J Q4 ’22 Earnings; and Embecta Opens New Headquarters

A series of cardiometabolic-related news items were observed from Tidepool, Lilly, Novo, Embecta, AGC Biologics, and Nemaura. Additionally, Abbott and J&J hosted Q4 ’22 earnings calls. Below, FENIX provides highlights and insights into the respective news items including commentary on why the claims against Novo’s marketing practices seem unfounded.

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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SELECT Doesn’t Stop at Interim Analysis; Novo Nordisk Q2 ’22 Earnings Update

Novo Nordisk hosted its Q2 ’22 earnings call (press release; slides), which was ahead of the initially scheduled call on August 4. Of note, management disclosed that following an interim analysis, the DMC recommended SELECT CVOT (view CT.gov record) should continue in accordance with the trial protocol. 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.

Ozempic 2.0mg Approved by FDA

Novo Nordisk announced its 2.0mg dose of Ozempic has been approved by FDA (view label), which is in line with FENIX’s projection. Recall, on May 28, 2021, Novo announced it resubmitted the sNDA to FDA following a Refusal to File Letter in January 2021 (previous FENIX insight). Of note, Novo indicated plans to launch 2.0mg Ozempic in Q2 ’22. Below, FENIX provides brief thoughts on the 2.0mg Ozempic approval.

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.

Wegovy Launch Impresses; Guidance Raised; Novo Q2 ’21 Earnings Update

Novo Nordisk hosted its Q2 ’21 earnings call and provided updates across its commercial and pipeline activities, including the ongoing Wegovy and Rybelsus launches and Novo’s intentions to develop and launch an ASCVD or HF product between 2024 and 2028. Of note, the earnings call was previously scheduled for tomorrow (August 5, 2021), but the company curiously moved it up by a day. 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.

Lilly Connected Pen Update; Novo Q1 ’21 Post-earnings Event; Provention Bio, BD, ICPT, and REGN Earnings Updates

A series of cardiometabolic-related news items have been observed: Lilly provided an update on its connected pen development, including the disclosure of the Tempo Smart Button (view press release); Novo Nordisk hosted its post-Q1 ’20 earnings event (see previous FENIX insight on Q1 ’21 Novo earnings from May 5); Provention Bio (press release), Becton Dickinson (press release), Intercept (press release; slides) and Regeneron (press release) hosted their respective CY Q1 ’21 earnings calls. Below, FENIX provides highlights and insights from the respective news items, including thoughts on BD’s decision to spin off its diabetes business.

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.