Tag Archives: Diabetes

Zealand Q4 ’19 Earnings Update

Zealand hosted its Q4 ’19 earnings call (press release) and provided updates to its diabetes business, including dasiglucagon and other pipeline assets. Of note, Zealand indicated that the dasiglucagon HypoPal NDA is on track for submission by the end of March 2020. Below, FENIX provides highlights and thoughts surrounding these updates.

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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Zyquista T1DM CRL stands (Lexicon Q4 ’19 Earnings Update); Jardiance CKD Fast Track Designation

Lexicon hosted its Q4 ’19 earnings call (press release) and provided brief updates on the Zyquista T1DM CRL appeal as well as the T2DM Ph3 development program. Additionally, Lilly announced the FDA’s fast track designation to Jardiance in chronic kidney disease (press release). Of note, CDER reaffirmed the FDA’s decision on the Zyquista T1DM CRL, stating the NDA application in T1DM could not be approved in its current form. Below are the key highlights and insights from Lexicon’s earnings call as well as the Jardiance CKD fast track designation, especially in the context of other ongoing renal outcomes trials.

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.

Lilly to Join New Part D Senior Savings Model for Affordable Insulins; Welldoc Partners With Dexcom

Yesterday, FENIX observed a series of diabetes-related news including an announcement that Welldoc partnered with Dexcom to integrate G6 into the BlueStar platform (press release) as well as Lilly plans to participate in the new Part D Senior Savings Model for affordable insulins (press release). Below, FENIX provides brief thoughts 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.

Xeris Q4 ’19 Earnings Update

Xeris hosted its Q4 ’19 earnings call (press release) and provided updates on its newly launched hypoglycemia rescue product Gvoke and other pipeline assets. To the best of our memory, this is believed to be the first time that Xeris hosted an earnings conference call to accompany its earnings release. Of note, Xeris also posted an updated corporate presentation from March 2020 to its IR website (presentation slides). Below, FENIX provides highlights and thoughts surrounding these updates, including how the coronavirus disruption could present an opportunity to Xeris.

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.

Nemaura enters into multiple non-binding agreements for sugarBEAT; Mylan wins over Sanofi in Lantus patent litigation

A series of diabetes-related news has been observed including an announcement that Nemaura has entered into multiple non-binding agreements for its sugarBEAT CGM (press release) as well as the US District Court ruling favorably for Mylan/Biocon’s bs-glargine over Sanofi’s Lantus (press release). Below, FENIX provides brief thoughts on these announcements in the context of the recent news from Nemaura and the potential launch of Mylan/Biocon’s bs-glargine.

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.

Intarcia CRL’d again, multiple outlets reporting

Multiple outlets are reporting that Intarcia has received a second CRL for ITCA-650 (see Boston Business Journal and STAT News for articles). FENIX has not seen an official company press release but will continue to monitor.

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 on FDA’s New Draft Guidance for T2DM Trials

FDA announced it has issued a new draft guidance titled “Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control” (download draft guidance here). Of note, this new draft guidance replaces two other FDA guidance documents – the famous Dec 2008 CV risk guidance and a Feb 2008 draft guidance. The new draft guidance provides recommendations on the size and nature of the safety databases needed to improve glycemic control in T2DM patients. Below, FENIX provides a brief overview of the FDA’s new draft guidance and its implications including a favors/disfavors analysis on specific market players.

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.

Intarcia PDUFA passes without update

It has been observed that Intarcia’s March 9 PDUFA date for ITCA-650 has passed. To the best of FENIX’s knowledge, there has been no company announcement from Intarcia and no new NDA database entries seen in an Orange Book search. Recall, after receiving a Sept 2017 CRL, Intarcia re-filed the ITCA-650 NDA on or around September 9, 2019, with a subsequent acceptance announcement on October 8, 2019 (previous FENIX insight). FENIX will provide analysis and market implications once a company announcement is made from Intarcia.

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.

New dapa HF study (DICTATE-AHF) in T2DM patients with acute decompensated heart failure

Last week, a Ph3 dapagliflozin trial (DICTATE-AHF) in T2DM patients with acute decompensated heart failure (ADHF) was observed on CT.gov. Of note, the study is assessing the decongesting effects of dapagliflozin and protocolized diuretic therapy in ADHF patients. Below, FENIX provides thoughts on this new trial in the context of other SGLT2 HF trials and what it could mean for AZ.

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.

Voluntis Deprioritizes Diabetes in Favor of Oncology

Voluntis announced it is moving in a new strategic direction, which includes deprioritizing its Insulia diabetes solution in favor of its oncology business. Of note, the updated strategy comes a day after Voluntis entered into an agreement with BMS to create a mobile solution to support treatment and track symptoms for oncology patients. Below, FENIX provides thoughts on Voluntis’s reprioritization in the context of other digital health solutions from Onduo and Livongo.

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.