Tag Archives: Wegovy

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.

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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

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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

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

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.

Provention Bio to Resubmit Teplizumab BLA; Novo’s Wegovy Shortage Resolution Appears on Track; Vertex Q4 ’21 Earnings Update

Three cardiometabolic-related news items have been observed: Provention Bio announced plans to resubmit the teplizumab BLA following its Type B pre-BLA resubmission meeting with FDA; It has been reported that Novo’s Wegovy shortage may be resolved by H2 ’22 (view article); and Vertex hosted its Q4 ’21 earnings call (press release; slides). Below, FENIX provides highlights and insights for the respective new 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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Novo Hosts Wegovy Shortage Call with Investors; Lannett Files Bs-glargine IND; Provention Adds New Management; Intercept NASH Data Delayed

A series of CVRM-related news items have been observed: Novo Nordisk hosted a call with investors to provide additional information and context on the recent announcement regarding its Wegovy supply constraints (view slides); Lannett announced it has filed an IND for its bs-glargine with the pivotal trial to begin in March 2022; Provention Bio announced it has expanded its executive team; and Intercept announced its Ph3 REVERSE trial topline data readout will be delayed to Q1 ’22. 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 Faces New Wegovy Supply Shortage

Novo Nordisk announced it is facing new Wegovy supply challenges in the US, and Novo will not be able to meet demand through H1 ’22. Novo said it will prioritize patients who have already initiated Wegovy treatment. According to the press release, the contract manufacturer has temporarily stopped deliveries and manufacturing due to “issues with Good Manufacturing Practices.” Novo plans to host a call with investors on December 20, 2021 to further discuss the Wegovy supply issue. Below, FENIX provides brief thoughts on the impact to the Wegovy launch.

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 Raises 2021 Guidance; Novo’s “Bigger Than Me” Anti-Obesity Awareness Campaign; Biocon’s Form 483 Observations Revealed; Novel Human Neo-Islet Technology Published

Four cardiometabolic-related news items have been observed: Novo Nordisk announced it has raised its 2021 guidance ahead of the Q3 ’21 earnings release on November 3; Novo has initiated an unbranded “Bigger Than Me” campaign for anti-obesity awareness featuring Queen Latifah (view article); It has been reported that details from the Form 483 observations made in FDA’s September 2021 pre-approval inspection of Biocon’s Malaysian facility were released to the public (view article); and SymbioCellTech announced pre-clinical data for its Neo-Islets technology have been published in PLOS ONE. 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 Q2 ’21 Post-earnings Event

Novo Nordisk hosted its post-Q2 ’21 earnings event and provided further details on the obesity market and Wegovy launch. Below, FENIX provides an overview of the commentary from senior management beyond what was discussed during the Q2 ’21 earnings call as well as 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.

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.