Tag Archives: Novo Nordisk

Novo Launches New Wegovy Campaign; Structure Reports Positive GSBR-1290 Topline Obesity Data

Two cardiometabolic-related news items have been observed: Novo Nordisk launched a campaign for Wegovy called “Power of Wegovy” highlighting Wegovy 2.4mg clinical data which includes CV risk reduction based on SELECT (view press release); and Structure Therapeutics reported positive topline data from its Ph2a GSBR-1290 obesity trial and its capsule to tablet PK study (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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Tandem Mobi Integrated with Dexcom G7; Ro Launches GLP-1 Supply Tracker; Novartis Initiates Ph4 Inclisiran vs. BA H2H Study; AZ Ph1 Oral PCSK9i Results; Catalent Stockholders Approve Acquisition by Novo

A series of cardiometabolic-related news items have been observed from Tandem, Ro, Novartis, AstraZeneca, and Catalent/Novo. 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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Purchase Blast$599.00

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

FDA Adcom Votes 4-7 Against Insulin Icodec T1DM Approval

Today, FDA held an Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to discuss the use of Novo Nordisk’s QW insulin icodec in T1DM patients, and panelists voted 4-7 against the icodec benefit/risk profile in T1DM patients. The split vote is largely unsurprising in the context of FDA’s concerns raised in the adcom briefing documents (previous FENIX insight). Below, FENIX provides highlights and insights from the icodec adcom, including additional thoughts on how a T2DM-only icodec indication would be a significant win for Novo (and Lilly).

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.

Full FLOW Results at ERA; Lilly Increases Manufacturing Investment to $9B

Two cardiometabolic-related news items have been observed: the full FLOW results were presented at ERA 2024 and simultaneously published in the NEJM (press release); and Lilly announced it increased its manufacturing investment for tirzepatide API production (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.

Novo to Face Uphill Battle; Insulin Icodec Adcom Briefing Documents Available

Briefing documents have been posted for FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to discuss the use of Novo Nordisk’s QW insulin icodec in T1DM patients (view here) which is being held on May 24, 2024. Below, FENIX provides an overview of FDA’s thoughts/concerns about the icodec benefit/risk profile and a prediction on how the adcom will turn out.

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 Partners with Metaphore for Next-Gen Obesity Assets; Altimmune, Xeris, MannKind, and Viatris Q1 ’24 Earnings

A series of cardiometabolic-related news items have been observed from Novo Nordisk/Metaphore Biotechnologies, Altimmune, Xeris, MannKind, and Viatris. 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.

Novo London, Tandem, and Lexicon Q1 ’24 Earnings

Three cardiometabolic-related news items have been observed: Novo hosted its post-Q1 ’24 earnings London analyst event (view webcast); and Tandem (press release) and Lexicon (press release) hosted their respective Q1 ’24 earnings calls. 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.

Novo to Face Two FDA Adcoms in 2024; Novo Q1 ‘24 Earnings

Novo to Face Two FDA Adcoms in 2024; Novo Q1 ‘24 Earnings

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.

FTC Investigating Diabetes and Obesity Orange Book Patent Listings; Pfizer and Amarin Q1 ’24 Earnings Update

Three cardiometabolic-related news items have been observed: FTC has expanded its investigation targeting “junk patent listings” for Novo’s diabetes and weight loss drugs, among others (view press release); Pfizer hosted its Q1 ’24 earnings (press release; slides; infographic); and Amarin hosted its Q1 ’24 earnings call (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.

Lilly Initiates Retatrutide CV and Renal Outcomes Study; Novo Initiates New Ph3 Cagrisema Maintenance Dose Study; US Senate Investigates Ozempic/Wegovy Pricing; Teladoc Q1 ’24 Earnings; Vance Swanson Joins Beta Bionics

A series of cardiometabolic-related news items have been observed from Lilly, Novo Nordisk, US Senate HELP Committee, Teladoc, and Beta Bionics. 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.