Tag Archives: Diabetes

Diamyd to Move Forward with Ph3 Trial in HLA-Present T1DM Subpopulation; Additional Results from DIAGNODE-2

Yesterday, Diamyd Medical hosted a webcast to present additional details and context from the DIAGNODE-2 trial evaluating the effectiveness of Diamyd (treatment) in preserving endogenous insulin production. Recall, topline results for DIAGNODE-2 were announced earlier this week. Of note, DIAGNODE-2 showed no significant effect in HLA DR3-DQ2-absent T1DM patients as HLA-present patients were the only ones to respond to the treatment. Below, FENIX provides an overview of the results, thoughts on the Ph3 program, and insight into Diamyd’s potential to move forward without a partner.

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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Dexcom Announces New CGM Registry and Global Business Service Site in Lithuania; Dario Appoints Former LifeScan Exec to Scientific Advisory Board

Yesterday, a series of diabetes-related news items were observed: Dexcom announced its first registry committed to tracking in-hospital real-time CGM use outcomes; Dexcom announced plans to build a global business service center in Lithuania; and DarioHealth appointed Eric Milledge as chairman of its Scientific Advisory Board. Below, FENIX provides highlights and insights on 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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Japanese NDA Submitted for Imeglimin; Poxel H1 ’20 Earnings Update

Yesterday, Poxel hosted its H1 ’20 earnings call and provided updates to its Japanese and US Imeglimin development. Of note, Poxel has submitted the Japanese NDA for Imeglimin and its US partner, Metavant, is actively preparing to initiate a Ph3 program in the US. Below, FENIX provides an overview of the Poxel earnings call and thoughts on Imeglimin development, including its market potential.

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.

Apple Cites T1DM Omnipod Patient Story at Tuesday Event; Jardiance Post-MI Trial (EMPACT-MI) Receives FDA FTD; Adocia Topline Results from M1Pram Ph1b Trial Extension; Welldoc/UMD Employs AI to Identify Digital Health Habits; Oramed’s Positive Diabetes Market Survey Results; Diamyd Receives $13.9M Towards Companion Medical Shares

A series of diabetes-related news items have been observed: Apple featured a T1DM patient story during the Apple Watch portion of its event; BI/Lilly announced Jardiance has received Fast Track designation for its EMPACT-MI study; Adocia announced positive topline results from its Ph1b M1Pram extension study in PWT1D; Welldoc and the University of Maryland’s Center for Health Information and Decision System (CHIDS) announced findings from a user engagement analysis; Oramed announced results from a diabetes market survey; and Diamyd received $13.9M from its divestment in Companion Medical. 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.

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Purchase Blast$599.00

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Senseonics Hosts Investor Event with Special Guest Ascensia

Today, Senseonics hosted a virtual investor event that also included a guest spot by Ascensia President, Robert Schumm. The goal of the event was to provide further detail to help inform financial analyst valuation models for SENS following the August 2020 partnership with Ascensia. Below, FENIX provides a summary and context from the information-rich event. 

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.

Diamyd’s Ph2b DIAGNODE-2 Trial Topline Results; New MicroTech Medical BGM 510(k) Clearance; Voluntis Announces €2M in Funding

A series of diabetes-related news items have been observed: Diamyd announced topline results from its Ph2b DIAGNODE-2 trial, and hosted a brief webcast to discuss the results; MicroTech received 510(k) clearance for its first BGM; and Voluntis secured €2M in financing. Below, FENIX provides highlights and insights related to 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.

High-dose Trulicity, DAPA-HF and Gvoke up for Opinions; CHMP Agenda September 14-17

The CHMP agenda for this month (September 14-17) has been released, and it includes three notable items: high-dose Trulicity, Dapa-HF, Xeris’s Gvoke, as well as several other agenda items. Below, FENIX provides diabetes-related highlights and insights from the September 2020 CHMP agenda.

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.

Thoughts on Newly Permanent Lilly Insulin+Baqsimi Copay Cards; New Novo+ACC ASCVD Registry; ProSciento Receives VC Investment

A series of diabetes-related news items have been observed: Lilly permanently committed to the Insulin Value Program $35 copay card besides other savings options for Humulin R U500 and Baqsimi; Novo Nordisk and ACC are launching a new ASCVD T2DM registry; and ProSciento closed a venture capital funding round. Below, FENIX provides an overview of the respective news items as well as thoughts on the economic benefit of the $35 insulin copay card compared to Semglee in addition to how the ACC partnership is beneficial to Novo.

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.

New Tirzepatide + Glargine U100 vs. Basal-Bolus Trial (SURPASS-6)

A new CT.gov record has been observed for a Lilly-sponsored Ph3 trial (SURPASS-6) comparing the safety and efficacy of tirzepatide vs. insulin lispro U100 in T2DM patients inadequately controlled on glargine U100 with or without metformin. Below, FENIX provides an overview of SURPASS-6 as well as insight into why the trial makes sense in the context of similar LCM trials conducted for Ozempic, Trulicity, Tanzeum, and Bydureon.

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.

Danilo Verge and David Kendall Join Zealand

Zealand announced it has appointed Danilo Verge and David Kendall to lead the company’s Medical Affairs organization. Verge, the former VP of AZ CVRM and VP of Novo Medical Affairs USA, will serve as Zealand’s Head of Global Medical Affairs for Zealand’s metabolic and gastrointestinal franchises (pictured bottom left; view LinkedIn profile). Kendall, former CMO at MannKind and VP of Lilly Global Medical Affairs, will serve as Senior Global Medical Advisor Metabolism (pictured bottom right; view LinkedIn profile). Below, FENIX provides thoughts on the new leadership in the context of Zealand’s emerging commercial business as well as Verge and Kendall’s moves.

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.