Tag Archives: FDA

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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Fractyl Q1 ’24 Earnings; 89bio Initiates Ph3 ENLIGHTEN-Cirrhosis; USPTO Extends Bempedoic Acid Patent; Inpefa HFpEF Post-Hoc Analysis

A series of cardiometabolic-related news items have been observed from Fractyl Health, 89bio, Esperion, and Lexicon. Below, FENIX provides highlights and insight 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

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Madrigal, Vertex, Ionis, Esperion, and Scholar Rock Q1 ‘24 Earnings; Tandem t:connect App Recalled

A series of cardiometabolic-related news items have been observed from Madrigal, Vertex, Ionis, Esperion, Scholar Rock, and Tandem. 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.

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.

Biomea and Fractyl Q4 ’23 Earnings; Glucotrack Implantable CGM Update; Costco Weight Loss Program; D&D Fast Track Designation in MASH; New Aligos Ph2a MASH Trial; Sernova Cell Pouch Updates

A series of cardiometabolic-related news items have been observed from Biomea Fusion, Fractyl Health, Glucotrack, Sesame/Costco, D&D Pharmatech, Aligos Therapeutics, and Sernova. 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.

Zepbound Supply Constraints Observed; NeuroBo Completes Ph2a MASH Trial Enrollment; Galectin Q4 ’23 Earnings

Three cardiometabolic-related news items have been observed: Lilly’s Zepbound is reportedly facing supply constraints in the US (view article); NeuroBo announced it completed enrollment of Part 1 of the Ph2a trial evaluating DA-1241 (GPR119 agonist) for the treatment of MASH (view press release); and Galectin recently reported its Q4 ’23 earnings (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.

Tandem Mobi Receives FDA Clearance; Better Therapeutics’s AspyreRx Receives FDA Authorization for T2DM

Two cardiometabolic-related news items have been observed: Tandem announced FDA clearance of the Tandem Mobi insulin pump for PWD ≥6 years of age (view press release); and Better Therapeutics announced FDA authorized AspyreRx to provide cognitive behavioral therapy for adults with T2DM and held an associated investor call (view press release; webcast). 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.

FDA Releases Framework for Use of Digital Health Technology in Clinical Trials; New Ph2 Dapiglutide Obesity Trial

Two cardiometabolic-related news items have been observed: As part of FDA’s PDUFA VII commitments, the Agency published framework (view here) describing how it plans to address questions on the use of digital health technology (DHT) in clinical trials; and a Ph2 trial evaluating Zealand’s subcutaneous QW dapiglutide in obese participants with a BMI ≥ 30 kg/m² has been observed (DREAM; 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.

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.

FDA Launches Digital Health Center of Excellence; Novo Initiates New Ozempic and Rybelsus Trials; vTv Presents TTP399 Data; EASD 2020 Key Press Releases (Sept 23)

On Day 3 of EASD 2020, two key press releases were observed from FDA and vTv Therapeutics. Additionally, two new semaglutide (Rybelsus and Ozempic) clinical trials were observed from Novo Nordisk. Below, FENIX provides insights and context from each respective announcement.

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.

Nothing New in Sota Adcom Federal Register Announcement

Today, the FDA published a notice in the Federal Register announcing the sotagliflozin adcom for Jan 17, which was press released yesterday by Lexicon. No notable new details were provided, and the proposed indication is in-line with expectations as “…Adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.”

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.