Tag Archives: dasiglucagon

Zealand Q4 ’20 Earnings Update; Nemaura Submits for sugarBEAT Reimbursement in Germany

Two diabetes-related news items have been observed: Zealand hosted its Q4 and FY 2020 earnings call (press release; slides); and Nemaura announced it has submitted sugarBEAT for reimbursement in Germany. In case you missed it, FENIX provided coverage of Zealand’s R&D Day on March 5, 2021 (previous FENIX insight). Below FENIX provides highlights and insights from the respective news items, including an analysis on whether Beta Bionics, who is partnered with Zealand for dasiglucagon, would launch the insulin-only iLet configuration or if it would wait for the bi-hormonal system.

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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Zealand R&D Day Highlights

Zealand hosted its R&D day (view slides) and provided updates to its diabetes and obesity development programs. Specifically, Zealand highlighted the near-term US approval and launch of the HypoPal glucagon rescue pen, medium-term development of the bi-hormonal iLet pump with Beta Bionics, and long-term research activities in obesity (e.g. amylin analog and GIP agonist). Below, FENIX provides highlights and insights from the events.

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 and Dario Q3 ’20 Earnings Updates; Tidepool Completes Loop Human Factors Validation Study

A series of diabetes-related news items have been observed: Zealand hosted its Q3 ’20 earnings call; DarioHealth hosted its Q3 ’20 earnings call; and Tidepool announced the completion of its human factors validation study for its automated insulin dosing app, Tidepool Loop. 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.

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.

Glucagon: Dasiglucagon Bi-hormonal Closed-Loop Pivotal Trial Delayed; Zealand Q2 ’20 Earnings Update

Zealand hosted its Q2 ’20 earnings call and discussed its clinical and commercial activities, including the acceleration of US commercial operations for the potential HypoPal launch in H1 ’21 and the delay in the bi-hormonal pivotal trial initiation which is now expected in early 2021. Below, FENIX provides brief thoughts 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.

Xeris Launches Gvoke HypoPen Autoinjector

Xeris announced the launch of its Gvoke HypoPen autoinjector (pictured below) for the treatment of severe hypoglycemia. The Gvoke website has also been updated, and it now includes a patient DTC video for HypoPen (view here). Below, FENIX provides thoughts on the Gvoke HypoPen launch as well as an analysis of the new DTC campaign in the context of Lilly’s Baqsimi (nasal glucagon) 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.

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 QW Insulin Icodec Ph2 Data; Lilly Pump Feasibility Data; New Dasiglucagon Data; January.ai Glucose Prediction Algorithm; Key Press Releases (June 14)

Today, four diabetes-related news items were observed: Novo presented Ph2 QW insulin icodec data in T2DM, Lilly presented feasibility data for its automated insulin delivery system, Zealand presented additional dasiglucagon data (including pediatrics), and January.ai showcased its new glucose prediction algorithm. Below, FENIX provides context and analysis for the announcements.

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.

Glucagon: Zealand Submits NDA for Dasiglucagon HypoPal Rescue Pen

Zealand Pharma announced it has submitted the dasiglucagon HypoPal Rescue Pen NDA for the treatment of severe hypoglycemia. Below, FENIX shares thoughts on the filing as well as the potential impact on the current glucagon rescue market including Lilly’s Baqsimi and Xeris’s Gvoke.

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.

Glooko Enables Free Remote Care Solution; Hovorka’s AP App Launched in UK; Valeritas Receives Court Approval on Zealand Sale

A series of diabetes-related news has been observed, including Glooko’s new remote patient care solution, the UK launch of Roman Hovorka’s artificial pancreas app ‘CamAPS FX’ for T1DM, and the court approval of the Valeritas sale to Zealand. 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.

Beta Bionics’s iLet Breakthrough Designation; Roche Receives CE Mark for Novel BG Test; Glooko Receives ISO 13485 Certification

FENIX has observed several announcements across diabetes technology players. First, Beta Bionics has received breakthrough device designation for the iLet Bionic Pancreas System from the FDA. Note, Beta Bionics is the only manufacturer to receive this designation for 3 system configurations (insulin-only as well as dual-hormone and glucagon-only using Zealand’s dasiglucagon), as no other companies have disclosed configurations beyond insulin-only. Additionally, Roche announced it has received CE Mark for the Accu-Chek SugarView, a meter-free BG monitoring system. Further, Glooko has received ISO 13485 certification, meeting requirements for safety and quality of their system. Below, FENIX provides context and insights on these announcements.

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.