Category Archives: Topics

New Oral Sema Primary Prevention CVOT (ASCEND PLUS)

Novo Nordisk and Oxford have initiated a new Ph4 T2DM CVOT, called ASCEND PLUS, evaluating 14mg QD oral semaglutide in 20,000 primary prevention patients (view CT.gov record). Of note, the trial was initially discussed back in June 2021, but it was just posted to CT.gov (view article). Interestingly, the study is said to be conducted virtually with no physical sites and all interactions being conducted using “innovative patient-centred web-based technology, supplemented by telephone, video call contact and mailed letters.” Below, FENIX provides an overview of the study and will conduct an in-depth analysis in the coming days.

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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Teplizumab Delayed Even Further; Lexicon Wins with LX9211; Novartis Buys a PRV; Nemaura FY ’21 Earnings Update

A series of cardiometabolic-related news items have been observed: Provention Bio announced FDA extended the teplizumab PDUFA date by 3 months to November 17, 2022; Lexicon announced positive LX9211 results in Diabetic Neuropathic Pain and hosted an associated call with investors (view webcast); Novartis has reportedly purchased a PRV from Mallinckrodt (view SEC filing); and Nemaura announced its fiscal year 2021 financial results, including updates on its non-invasive CGM product launches (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 Sues Orbicular Pharmaceuticals Over Generic Saxenda; Sema Ph2 NASH Trial Disappoints; Kerendia Receives New Recommendations from ADA; Sanofi Cuts Insulin Price and Partners with Direct Relief; Novartis to Cut 8,000 Jobs Worldwide; Lifescan Publishes Connected BGM RWE

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Bayer, Sanofi, Novartis, and Lifescan. 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.

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 Initiate Ph1 Sema+Dapa FDC Ph1 Trial; ProKidney Publishes Data Supporting MoA of REACT in Patients with Diabetic CKD; Cytokinetics Announces Date for Omecamtiv FDA Adcom; Hygieia licenses d-Nav program in Israel

A series of cardiometabolic-related news items have been observed: a two-part Ph1 Novo-sponsored study evaluating a semaglutide/dapagliflozin FDC has been observed (view CT.gov record); ProKidney recently announced the publication of data from an MoA study of its Renal Autologous Cell Therapy (REACT) in Kidney International Reports (view publication here); Cytokinetics announced FDA informed the company the omecamtiv adcom has been scheduled for December 13, 2022; and Hygieia announced it licensed its d-Nav insulin management system to Movement Group in Israel. 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.

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 and Echosens Partnership to Increase NASH Awareness; GlucoTrack to Initiate First In-human Clinical Study for GlucoTrack 2.0

Two cardiometabolic-related news items have been observed: Novo Nordisk and Echosens announced a partnership to increase awareness and advance early diagnosis of NASH; and GlucoTrack, formerly known as Integrity Applications, provided development updates on its Gen 2 non-invasive glucose monitor (press release). 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.

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.

Illinois Expands Insurance Coverage to Include CGMs; Adocia Announces Positive Top-line Results from Ph2 M1Pram Trial; June 20-23 CHMP Agenda

Three cardiometabolic-related news items have been observed; new Illinois law requires insurance and managed health plans to expand insurance coverage to include CGMs for people with T1DM and T2DM (view article); Adocia announced positive top-line results from its Ph2 trial (view CT.gov record) comparing M1Pram to Humalog in T1DM; and the CHMP agenda for this month’s meeting (June 20-23) has been released. 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.

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.

Senseonics Eversense E3 CGM Receives CE Mark; Tandem Appoints Two New Members to Board of Directors; Akero Announces Financing Transactions with Pfizer and Hercules Capital

Three cardiometabolic-related news items have been observed: Senseonics announced it has received CE Mark for the next-generation Eversense E3 CGM system; Tandem announced the appointment of two new directors to its board; and Akero Therapeutics announced two financing transactions with Pfizer and Hercules Capital. 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.

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.

Updated Abbott vs. Dexcom CGM Tale-of-the-tape Analysis

The CGM market continues to be dynamic, most recently with Abbott’s Libre 3 receiving FDA approval (previous FENIX insight) and Dexcom’s G7 approval right around the corner. Both companies represented well at ATTD and ADA, and momentum should continue into EASD (Sept 19-23). With Dexcom’s G7 US approval anticipated soon, FENIX updated its tale-of-the-tape comparative analysis between Abbott’s Libre 2 and 3 vs. Dexcom’s G6 and G7 CGM systems.

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.

Zealand Presents Ph1 Dapiglutide Trial Data; Novo and GluCare Partnership for Innovative Weight Management Program; Ginkgo and Novo Collaboration on Expression Systems; Sanofi launches first Digital Accelerator

Four cardiometabolic-related news items have been observed: Zealand recently announced results from its Ph1b GLP-1/GLP-2 dapiglutide; GluCare.Health announced a partnership with Novo Nordisk for an innovative weight management pilot program to launch in September; Ginkgo Bioworks recently announced a collaboration with Novo Nordisk to create new expression hosts for pharmaceutical products using synthetic biology; and Sanofi recently announced the launch of its first Digital Accelerator. 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.

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.

Thoughts after ATTD and ADA 2022

Now that we’re on the other side of ADA 2022, FENIX provides provocative thoughts below on various items in the cardiometabolic space. Included are thoughts about Lilly, Novo, Sanofi, Dexcom, Abbott, Medtronic, Bigfoot, and Beta Bionics.

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.