Tag Archives: FDA

Dexcom Hosts Stelo Webinar; Libre 3 CGM Recall; Novartis Positive Ph3 Leqvio Trial Results; President Biden Releases Statement on AOM Prices

A series of cardiometabolic-related news items have been observed from Dexcom, Abbott, Novartis, and the Biden Administration. 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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Novo Ph1 GLP/GIP RA Obesity Study; Pfizer Ph1 Danuglipron Study; D&D Ph2b MASH Study; Skye Ph2 Nimacimab Obesity Trial Initiation; FDA Denies Intarcia’s T2DM Device

A series of cardiometabolic-related news items have been observed from Pfizer, Novo Nordisk, D&D Pharmatech, Skye Bioscience, and Intarcia. 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.

Lexicon Zynquista Adcom; Sesame to Offer Compounded Semaglutide

Two cardiometabolic-related news items have been observed: Lexicon announced an FDA adcom for Zynquista in T1DM with CKD has been set for October 31, 2024 (view press release); and Sesame announced it will offer compounded Wegovy through Success by Sesame, its new weight-loss program (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.

ADA 2024 Key Press Releases (June 21)

On the first day of ADA 2024, three cardiometabolic-related news items were observed: Lilly announced detailed results from its Ph3 SURMOUNT-OSA trial presented at ADA 2024 and published in the NEJM (view press release); Lexicon announced it resubmitted the sotagliflozin NDA for adjunctive treatment of T1DM and CKD (view press release); and Vertex Pharmaceuticals announced new data from its Ph1/2 trial of VX-880 (view press release). Below, FENIX provides context and insight 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 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.

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.

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.

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.

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.

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.

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.