Tag Archives: Novo Nordisk

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to develop bioprinted tissue therapeutics for diabetes and obesity (view press release); Sanofi announced it has withdrawn and refiled its Premerger Notification and Report Form under the Hart-Scott-Rodino Act of 1976 (HSR Act) for its pending acquisition of Provention Bio (view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.

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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

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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.

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Purchase Blast$599.00

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

89bio Positive Ph2b Pegozafermin NASH Data; Novartis Discontinues Inclisiran UK Primary Prevention Trial; Novo Nordisk Partners with Dewpoint Therapeutics; Evkeeza Receives Pediatric Approval

A series of cardiometabolic-related news items have been observed from 89bio, Novartis, Dewpoint Therapeutics, and Regeneron. 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.

CMS Expands CGM Coverage; New Novo R&D Presence in Boston; Bigfoot Unity Android App Approval; Cytokinetic Receives Omecamtiv CRL; Galectin Finalizes Ph2b/3 NAVIGATE Randomization; Imcyse Completes Trial Enrollment; and Zealand, Intercept, and Amarin Q4 ’22 Earnings

A series of cardiometabolic-related news items has been observed from CMS, Novo Nordisk, Bigfoot, Zealand, Intercept, Cytokinetics, Amarin, Galectin, and Imcyse. 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.

Insulet and MannKind Q4 ’22 Earnings; Novo Initiates Wegovy DTC; FDA Accepts G&L’s Bs-Glargine U100 BLA; Vadadustat Receives Positive CHMP Opinion; ATTD 2023 Key Press Releases Day 3

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Insulet, MannKind, Gan & Lee, Medtronic, and Akebia. 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.

Insulet Acquires Bigfoot’s Insulin Pump IP; Dexcom G7 Receives Medicare Reimbursement; Novo Initiates New Sema Pediatric Obesity Trial; Sanofi Completes $35M Investment in Provention; Sanofi Announces Change in R&D Leadership

A series of cardiometabolic-related news items were observed from Insulet, Bigfoot, Dexcom, Novo Nordisk, and Sanofi. 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.

Novo Nordisk and Heartseed Dose First Patient in Ph1/2 LAPiS Trial of HS-001; Finerenone Receives EU Approval for FIGARO-DKD Label Extension

Two cardiometabolic-related news items have been observed: Novo Nordisk and Heartseed announced the first patient has been dosed in the Ph1/2 LAPiS study (view CT.gov record) evaluating HS-001 in 10 patients with advanced HF caused by ischemic heart disease (view press release); and Kerendia (finerenone) has received EU approval for label extension to include CV outcomes in patients with CKD and T2DM (view Kerendia EPAR). 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.

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.

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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.

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.