Category Archives: Basal Insulin

Dexcom Q3 ’23 Earnings

Dexcom hosted its Q3 ’23 earnings call (press release; slides) and provided updates across its business. Of note, Dexcom’s stock price increased approximately +15% in after-hours trading due to the positive quarterly performance. Below, FENIX provides highlights 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.

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FDA Accepts Vadadustat NDA Resubmission; Glooko Appoints Enrique Conterno to Board of Directors; Novo Launches “iCARE4CVD”; Todd Hobbs Joins Diasome as CMO; Teladoc Q3 ’23 Earnings

A series of cardiometabolic-related news items have been observed from Akebia, Glooko, Novo, Diasome, and Teladoc. Below, FENIX provides highlights and insights into 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.

Abbott Q3 ’23 Earnings; Tzield PROTECT Data at ISPAD 2023; Viking GLP-1/GIP RA Ph1 Data at ObesityWeek

Three cardiometabolic-related news items have been observed: Abbott hosted its Q3 ‘23 earnings call and disclosed there are now 5M Libre users globally (press release; infographic); Sanofi presented data from the PROTECT Ph3 trial evaluating teplizumab in newly diagnosed T1DM (view press release); and Viking Therapeutics announced new results from the Ph1 SAD/MAD clinical trial evaluating its GLP-1/GIP RA, VK2735 (view press release). Below, FENIX provides highlights and insights into 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.

Best Buy to Sell Dexcom G7; Gan & Lee Submits Bs-aspart and Bs-lispro MAAs; October CHMP Agenda; Tom Garner Joins Lexicon as SVP and CCO; Dario Partners with a Top Five Employee Benefits Consulting Firm; Senseonics and Ascensia Launch Eversense E3 Advertising Campaign

A series of cardiometabolic-related news items have been observed from BestBuy/Dexcom, Gan & Lee, EMA, Lexicon, Dario, and Senseonics/Ascensia. Below, FENIX provides highlights and insights into 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.

EASD 2023 Key Press Releases (Oct 03)

On the second day of EASD 2023, three key news items were observed from the Biden-Harris administration, Novo Nordisk, and Galectin Therapeutics. The following topics are covered below (hyperlinks to external 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.

EASD 2023 Key Press Releases (Oct 02)

On the first day of EASD 2023, two key news items were observed from Novo Nordisk and Dexcom. The following topics are covered below (hyperlinks below are to external 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.

Lilly Initiates New Ph2 Study Investigating High Doses of Tirzepatide in Patients with T2DM and Obesity; Gan & Lee Doses First Patient in Ph2 QW Insulin Study; BMS discontinues NASH asset

Three cardiometabolic-related news items have been observed: Lilly initiated a Ph2 study to investigate high doses of tirzepatide in patients with T2DM and obesity that are on metformin (view CT.gov record); Gan & Lee announced the first subject has been dosed in its Ph2 study evaluating QW insulin, GZR4, in 130 Chinese adult subjects with T2DM (view press release); and BMS disclosed it is terminating its program evaluating HSP47 in NASH during its R&D day (view article). Below, FENIX provides highlights and insights into 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.

September CHMP Agenda; Nemaura Announces Interim 24-Hour Wear sugarBEAT Results; Madrigal Appoints Bill Sibold as CEO

Three cardiometabolic-related news items have been observed: The CHMP agenda (view here) for this month’s meeting (September 11-14) has been released; Nemaura Medical announced interim results from a 100-patient study across 4 cohorts of 25 (view press release); and Madrigal Pharmaceuticals announced Bill Sibold as the successor to Paul Friedman as CEO (view press release). Below, FENIX provides highlights and insights into 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 Secures $100M in Series D Funding; Senators Ask for Clarity on Lilly, Novo, and Sanofi’s Low-cost Insulin Products

Two cardiometabolic-related news items have been observed: Beta Bionics announced its Series D funding round has been closed at $100M (view press release); and senators have sent a letter to the CEOs of Lilly, Novo Nordisk, and Sanofi asking for greater clarification on how patients may participate in each company’s Patient Assistance Programs to obtain insulin at an affordable price (view letter; view article). 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.

Gan & Lee Submits Bs-glargine MAA

Gan & Lee Pharmaceuticals announced the MAA for its biosimilar insulin glargine U100 (Basalin) has been accepted for review by EMA. According to the press release, the MAA filing is supported by two randomized, multicenter Ph3 studies in the US and EU comparing its bs-glargine injection to Lantus in which bs-glargine demonstrated comparable immunogenicity, efficacy, and safety to Lantus in T1DM (n=576) and T2DM (n=567) patients (previous FENIX insight). G&L said it will continue to collaborate with Sandoz to commercialize its bs-glargine in the EU. Recall, in February 2023, G&L announced FDA accepted the BLA for its bs-glargine (previous FENIX insight). Below, FENIX provides brief thoughts on the G&L bs-glargine MAA in the context of the evolving basal insulin market.

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.