Category Archives: Glucagon

Zegalogue (Dasiglucagon) Label Analysis

Zealand recently announced its dasiglucagon hypoglycemia rescue product, branded as “Zegalogue,” received FDA approval (view label; previous FENIX insight). Following the approval, Zealand hosted an investor webcast to provide additional details surrounding the commercialization of Zegalogue (view slides). Below, FENIX has conducted a Zegalogue label analysis in the context of 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.

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Zealand’s Dasiglucagon Approved; March 22-25 CHMP Agenda; Fractyl Enrolls First Patient in T2DM Study; Twist Bioscience Announces Positive Preclinical Data

A series of cardiometabolic-related news items have been observed: Zealand’s dasiglucagon has been approved in the US as “Zegalogue” for the treatment of severe hypoglycemia in patients 6 years of age and older; the CHMP agenda for this month’s meeting (March 22-25, 2021) has been released; Fractyl announced the first patient has been enrolled in a pivotal trial of Revita DMR; and Twist Bioscience announced positive preclinical data in which its library identified GLP-1R antibodies that demonstrated glucose control. Below, FENIX provides highlights and insights from the respective news items, including thoughts on two potential generic sitagliptin products on the 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

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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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Purchase Blast$599.00

You can read the article’s full content online after purchase.

Xeris and Dario Q4 and FY ’20 Earnings Calls; Lilly Research Collaboration for Diabetes; Metacrine Initiates Ph2a Trial in NASH

A series of cardiometabolic-related news items have been observed: Xeris and Dario hosted their Q4 and FY ’20 earnings calls; Lilly announced it entered a research collaboration and license agreement with Biolojic Design for AI drug discovery of an antibody-based diabetes treatment; and Metacrine announced that it initiated a Ph2a trial of MET642 for the treatment of patients with NASH. 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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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.

Biocon/Viatris Bs-aspart and Xeris RTU Glucagon Receive EC Approval; Poxel Q4 and FY ’20 Earnings Update

A series of cardiometabolic-related news items have been observed: Biocon/Viatris announced EC approval for their rapid-acting bs-insulin aspart, branded as Kixelle; Xeris announced it received EC approval for its RTU rescue glucagon product, branded as Ogluo; and Poxel announced its Q4 and FY ’20 earnings. 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.

Adocia Reports Positive BC Lispro Data with Tonghua Dongbao Insulin; January 25-29 CHMP Agenda

A series of cardiometabolic-related news items have been observed: Adocia announced positive results from a BioChaperone Lispro trial using insulin sourced from Tonghua Dongbao; and the CHMP agenda for this month’s meeting (January 25-29, 2021) has been released, and it includes one notable item: EMPEROR-Reduced is on the CHMP agenda but not believed to be up for an opinion. 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.

Holiday Hangover: FDA Approves First Generic Glucagon; Novo High-dose Sema EU Filing; Novo Extends COVID-19 Relief Program; Eversense Implantable CGM Delayed by FDA; Provention Bio’s Teplizumab Filing Accepted by FDA; Teplizumab July 2, 2021 PDUFA

During the holiday break, a series of diabetes-related news items were observed from Amphastar, Novo Nordisk, Senseonics, and Provention Bio. 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.

Xeris Enters Gvoke Distribution Agreement in Israel and Palestine; Dario Partners with Presbyterian Medical Services

Two diabetes-related news items have been observed: Xeris announced an exclusive distribution agreement with Megapharm Ltd. for the commercialization of Gvoke in Israel and Palestine; and DarioHealth announced a partnership with Presbyterian Medical Services to provide patients with chronic conditions access to Dario’s digital therapeutics. 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.

Xeris Recieves Positive CHMP Opinion; Roche and Diabeloop Partner for AID Development

Two diabetes-related news items have been observed: Xeris announced it received a positive CHMP opinion for its ready-to-use (RTU) rescue glucagon product, called Ogluo, and Roche announced a partnership with Diabeloop to enhance Roche’s pump hardware platform. 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.