Category Archives: Insulin Delivery

Lilly Ends Ypsomed Partnership; Cytokinetics Adcom Documents Available

Two cardiometabolic-related news items have been observed: Ypsomed announced Lilly terminated the joint project with Ypsomed to enter the US insulin pump market in 2026 (view press release); and Cytokinetics announced FDA posted briefing documents (view here) for its upcoming omecamtiv adcom which is scheduled for December 13, 2022 (view press release). Below, FENIX provides brief insights on the news items, including how Lilly’s decision to terminate the partnership validates FENIX’s initial thoughts from 2020.

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.

Esperion’s CLEAR Outcomes CVOT Meets Primary Endpoint; Biocorp’s Mallya Receives FDA 510(k) Clearance; Jardiance Meets Primary Endpoint in Pediatric Trial; MediciNova MN-001 (tipelukast) T2DM and NAFLD Ph2 Data; Daewoong Looks to Commercialize Enavogliflozin Globally

A series of cardiometabolic-related news items have been observed from Esperion, Biocorp, BI/Lilly, MediciNova, and Daewoong Pharmaceutical. Below, FENIX provides highlights and insights for the respective news items, including thoughts on the positive clinical data.

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.

Libre 3 + Ypsomed AID Authorized in Germany; Diamyd Ph3 T1DM Clinical Hold Lifted

Two cardiometabolic-related news items have been observed: Ypsomed announced that its mylife Loop is authorized to work with Abbott’s FreeStyle Libre 3 in Germany (view press release); and Diamyd announced FDA lifted the clinical hold on the Ph3 DIAGNODE-3 trial (view press release; view CT.gov record). Below, FENIX provides context and insight on 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.

Medtronic CY Q3 ’22 Earnings Update; Novo Expands Manufacturing Facilities; FDA Approves Lilly’s Rezvoglar as an Interchangeable Biosimilar; Oramed Presents Additional Ph2 PRMD-0801 NASH Data

Four cardio-metabolic related news items have been observed: Medtronic hosted its CY Q3 ’22 earnings call (press release; slides); Novo announced plans to invest DKK 5.4B (~$750M USD) in the expansion of manufacturing facilities in Denmark (view press release); FDA approved Lilly’s Rezvoglar (bs-glargine) as an interchangeable to Sanofi’s Lantus (view label; view article); and Oramed hosted an event to discuss data from its Ph2 trial evaluating 8mg ORMD-0801 compared to placebo in 32 participants with T2DM and NASH (slides; webcast; press release). Below, FENIX provides context and insight on 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.

Medtronic Launches Extended Wear Infusion Set; Dario Q3 ’22 Earnings Update; Versanis Bio Initiates Ph2 Bimagrumab Study in Obesity

Three cardiometabolic-related news items have been observed: Medtronic announced the US launch of its extended wear infusion set; Dario hosted its Q3 ’22 earnings call and provided updates on its digital health portfolio (press release); and Versanis Bio has initiated a Ph2 trial evaluating the safety and efficacy of Q12W bimagrumab monotherapy or in combination with semaglutide in overweight or obese patients (view CT.gov record). 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.

Lilly and Novo Leave Twitter Advertising; Insulet Issues O5 Medical Device Correction; Biocon, Movano, and Nemaura Q3 ’22 Earnings Updates

A series of cardiometabolic-related updates have been observed: Lilly (view article) and Novo (view article) have reportedly halted Twitter advertising; Insulet announced an Omnipod 5 voluntary medical device correction in the US; Biocon (press release), Movano (press release), and Nemaura (press release) hosted their respective Q3 ’22 earnings calls. Below, FENIX provides context and insight on 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.

AZ and Zealand Q3 ’22 Earnings Updates; Novo Smart Pen Integration with Libre

Three cardiometabolic-related news items have been observed: AstraZeneca (press release; slides) and Zealand (press release; slides) hosted their Q3 ‘22 earnings calls, where Zealand talked about its dual agonist’s weight loss data; and Novo Nordisk announced its smart pens can now connect to Abbott’s FreeStyle LibreLink app in the UK. Below, FENIX provides context and insight on 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 Connected Pen US Launch in 2022; Lannett Partners with Ypsomed; Eversense to Integrate with Apple; Viatris Q3 ’22 Earnings Update; November CHMP Agenda

A series of CVRM-related news items have been observed: Lilly announced plans to launch its Tempo Personalized Diabetes Management Platform to select US clinics in 2022; Lannett announced a partnership with Ypsomed for insulin pen delivery; Ascensia announced the Eversense implantable CGM now integrates with Apple Health; Viatris hosted its Q3 ’22 earnings and provided brief updates to its bs-insulin portfolio divestiture (press release; slides); and the November CHMP agenda (view here) has been released. 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.

Insulet, Provention Bio, Madrigal, and Regeneron Q3 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Insulet (press release), Provention Bio (press release), and Regeneron (press release; slides) hosted their Q3 ’22 earnings calls and; Madrigal issued a press release for its Q3 ‘22 earnings, though it did not host an associated webcast. 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.

Tandem and Lannett Q3 ’22 Earnings Updates; Indigo Expands into US; OrsoBio Acquires T2DM and NASH Assets

A series of cardiometabolic-related news items have been observed: Tandem (press release) and Lannett (press release) hosted their CY Q3 ’22 earnings calls; Indigo Diabetes announced the creation of a US entity and appointment of Peter Devlin as President to support the development and commercialization of its continuous multi-metabolite (CMM) device; and Orso Bio acquired a T2DM asset from Shionogi (press release) and exclusive global rights for intellectual property from Yale University to develop mitochondrial protonophores (press release). Below, FENIX provides highlights and insights for the respective new 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.