Category Archives: Insulin Delivery

Lilly Initiates Additional Ph3 Orforglipron Trial; Mounjaro Label Update; Vertex, Amarin, and Intercept Q2 ‘23 Earnings; Glenmark Receives ANDA Approval for 2.5mg and 5mg Saxagliptin; Dario Introduces GLP-1RA Obesity Program; Tandem Initiates Sigi Patch Pump Trial

A series of cardiometabolic-related news items have been observed from Lilly, Vertex, Amarin, Intercept, Glenmark, Dario, and Tandem. 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.

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Afon to Launch Non-Invasive Blood Glucose Sensor in 2024; DEKA ACE Pump Receives 510(k) Clearance; Novo Nordisk Launches Wegovy in Germany; Ionis Completes CARDIO-TTRansform Enrollment

Four cardiometabolic-related news have been observed: Afon Technology is planning to launch a noninvasive blood glucose sensor, called Glucowear, in 2024 (view article); DEKA Research and Development received 510(k) clearance for its DEKA ACE Pump System (view 510(k) decision letter); Novo Nordisk launched Wegovy in Germany without coverage from public health insurance (view article); and Ionis announced the completion of enrollment for its Ph3 CARDIO-TTRansform CVOT of eplontersen in patients with ATTR-CM (view CT.gov record). Below, FENIX provides highlights and insights into the respective news items, including thoughts on who may be interested in commercializing the DEKA pump.

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.

Wegovy Label Update; Jardiance Receives EMPA-KIDNEY Approval in EU; Glucotrack Announces Positive Implantable CGM Data; Thane Wettig Succeeds Enrique Conterno as Fibrogen CEO

Four cardiometabolic-related news items have been observed: The Wegovy US label has been updated to include 1.7mg as a second maintenance dose in addition to the 2.4mg dose (view label); BI/Lilly announced the European Commission (EC) approved Jardiance for the treatment of adults with CKD (view press release); Glucotrack announced positive results from the feasibility study for its implantable CGM (view press release); and Fibrogen announced the resignation of Enrique Conterno, with Thane Wettig taking over as interim CEO (view press release). Below, FENIX provides highlights and insights on the respective news items, including insight into Novo’s potential rationale for adding another Wegovy maintenance dose.

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 Q2 ’23 Earnings; Merck Initiates Ph3 Oral PCSK9i Program; Pfizer Partners with Riparian for CV Development; Amarin Corporate Updates; J&J Q2 ’23 Earnings

Five cardiometabolic-related news items have been observed from Abbott, Merck, Pfizer, Amarin, and Johnson & Johnson. Importantly, Abbott disclosed it is converting Libre 2 intermittent scanning CGMs into real-time CGMs through an app update, starting with the UK. Below, FENIX provides highlights and insights from the respective news items, including potential insight into Abbott’s rationale for the Libre 2 LCM initiative.

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.

Tandem Mobi Receives FDA Clearance; Better Therapeutics’s AspyreRx Receives FDA Authorization for T2DM

Two cardiometabolic-related news items have been observed: Tandem announced FDA clearance of the Tandem Mobi insulin pump for PWD ≥6 years of age (view press release); and Better Therapeutics announced FDA authorized AspyreRx to provide cognitive behavioral therapy for adults with T2DM and held an associated investor call (view press release; webcast). 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.

Lilly Initiates Three New Ph3 Retatrutide Obesity Trials; Zealand Ph1 Amylin Analog Results; Zealand Dasiglucagon CHI NDA Submitted; Sanofi Signs M1Pram Exclusivity Agreement with Adocia; Dexcom G7 Approved in Canada

Five cardiometabolic-related news items have been observed: Lilly initiated three new trials in the Ph3 retatrutide obesity program, TRIUMPH (TRIUMPH-1; TRIUMPH-2; TRIUMPH-4); Zealand announced positive results from Part 1 of the Ph1 MAD trial evaluating its amylin analog, ZP8396 (view press release); Zealand also submitted the dasiglucagon NDA for congenital hyperinsulinism (view press release); Adocia signed an exclusivity agreement with Sanofi for M1Pram (view press release); and Dexcom’s G7 CGM received Health Canada approval for individuals aged 2 years and older (view press release). Below, FENIX provides highlights and insights into the respective news items, including a projected regulatory timeline for retatrutide and brief thoughts on next-gen obesity drugs.

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.

NICE Requests Additional Tirzepatide T2DM Data; Insulet Initiates Omnipod 5 + Libre 2 Study; Esperion Files CLEAR Outcomes in EU; Nemaura Expands proBEAT Pilot; NeuroBo and Terns Announce Preclinical Obesity Data

A series of cardiometabolic news items have been observed from NICE, Insulet, Esperion, Nemaura, NeuroBo, and Terns. 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.

Lilly Poised to Own the Obesity Market; ADA 2023 Key Press Releases (June 26)

On the last day of ADA 2023, nine cardiometabolic-related news items were observed from Lilly, Pfizer, Fractyl Health, Zealand Pharma, Vertex, Sernova, Senseonics, Dario, and GSK. 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.

Medtronic Admits It Can’t Achieve iCGM Designation?; 2023 ADA Investor Event

Medtronic hosted its ADA 2023 investor event (view slides) and provided updates to the company’s diabetes business. Of note, commentary from Medtronic senior management indicates the Simplera CGM will not achieve an iCGM designation. Additionally, it should be noted that Medtronic’s CEO, Geoff Martha, participated in the ADA investor event, which hasn’t been the case in recent memory. Below, FENIX provides an overview of the Medtronic 2023 ADA investor event, including thoughts on Medtronic’s continued inability to achieve iCGM designation.

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.

ADA 2023 Key Press Releases (June 24)

On the second day of ADA 2023, ten cardiometabolic-related news items were observed from Lilly, Zealand, BI, Novo Nordisk, Biomea Fusion, Sciwind Biosciences, Medtronic, Vertex, and Esperion. 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.