Category Archives: Insulin Delivery

Lilly 2019 Guidance Summary

Today, Lilly hosted its 2019 Guidance and Investment Community Meeting and discussed potential key milestones for 2019. Importantly, Lilly announced late stage development plans in obesity and NASH and provided more information on the Ph3 dose titration for its QW injectable GIP/GLP-1 dual agonist tirzepatide. Connected care was also featured, and several comments were made on guidelines updates and new PBM coverage positively affecting Trulicity and Jardiance in 2019. Below, FENIX provides a summary and thoughts on diabetes-related highlights from the event. 

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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Gan and Lee + Sandoz and FDA Biosimilar Insulin BLA List

Today, Sandoz announced it has in-licensed the biosimilar insulin portfolio of Gan & Lee for commercialization of glargine, aspart, and lispro. Last week, FDA published a Q&A document and a list of biologics that will convert from NDA to BLA under the US BPCI Act of 2010, which include insulin products. Below, FENIX briefly provides thoughts on each topic.

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’s Evidation Health Collaboration Expanded To Discover Novel Digital Health Measures

Today, Lilly and Evidation Health announced the expansion of their collaboration with a multi-year agreement that will provide Lilly with global access to Evidation’s Andromeda data platform. Of note, Evidation Health also has prior partnerships with Tidepool and Sanofi. Below, FENIX provides additional thoughts on this collaboration in the context of Lilly’s connected care strategy in diabetes. According to the press release, Lilly will leverage the Andromeda data platform across different therapeutic portfolios, including diabetes, to support the clinical utility of digital medicine and improve personalized health outcomes. The press release also noted that Andromeda data platform is being used……

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.

Tidepool Loop funded at $6M

Today, JDRF and Helmsley Charitable Trust announced a collaborative grant agreement by providing $6M of funding to Tidepool for the development of “Tidepool Loop”. Recall, Loop is an open-source, unregulated automated insulin delivery (AID) app for iPhone that connects to an insulin pump and CGM using BLE (see image below). Of note, Tidepool intends on further developing the app by making it an FDA-regulated, hybrid closed-loop AID app for iOS with interoperability across multiple insulin pumps and CGMs. Below, FENIX provides additional thoughts on Tidepool Loop. Source: Tidepool website This news comes as no surprise considering the recent announcement from Tidepool in October 2018, indicating the initiation of the Loop project, which aimed to develop……

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 Mylan and Lilly trials: Ph3 biosimilar insulin aspart study, Ph2 URLi study in 670G

Last week, new Mylan and Lilly trials were observed on CT.gov. These include a Ph3 biosimilar insulin aspart study in T1DM by Mylan and a Ph2 URLi study by Lilly with Medtronic’s 670G closed-loop system. Below, FENIX provides thoughts on each of the respective studies. Mylan Ph3 Biosimilar Insulin Aspart Study in T1DM Mylan has initiated a Ph3 study for its biosimilar insulin aspart in T1DM with NovoLog as the comparator. This new trial is in-line with previous guidance from Mylan indicating the initiation of a Ph3 study in H2 ’18. Previously, it was anticipated that Mylan would initiate a 52-week Ph3 trial……

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.

Onduo Free Promotional Program; Insulet Dash Meets ISO Standards

Onduo announced it is giving away subscriptions to its virtual diabetes program to patients in Georgia. Additionally, Insulet announced it received ISO 27001 certification for its Omnipod Dash. Below, FENIX provides insight into how Onduo could be leveraging the giveaway with payers and the impact of digital security to Insulet’s smartphone-controlled pumps. Onduo Virtual Diabetes Care According to the press release, Onduo will giveaway a 12-month subscription to its virtual diabetes care program to the first 1,000 eligible patients in Georgia. Of note, the promotion coincides with National Diabetes Awareness month.  While it remains speculation, Onduo managed care coverage in Georgia could be lagging behind the……

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 ’18 (FY Q2 ’19) Earnings Update

Medtronic hosted its CY Q3 ’18 (FY Q2 ’19) earnings call and provided brief updates to its diabetes device pipeline and commercial activities including the ongoing launch of its standalone CGM, Guardian Connect. Below, FENIX provides key highlights of the earnings call as well as perspective on Medtronic’s push into the standalone CGM 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.

Thoughts on the Regulatory Environment in Diabetes

The regulatory environment in diabetes has greatly evolved in the last 10 years since the 2008 FDA CV risk guidance. As recently as ADA and now through EASD in 2018, FENIX considers the regulatory environment in the US and Europe to be highly favorable for sponsors developing diabetes drugs, devices, and technological solutions. Below, FENIX provides its perspective in a winners and losers analysis on how the highly favorable regulatory environment could be positively impactful to the key upcoming 2019 market events in diabetes from sponsors like Lexicon, Sanofi, AZ, Janssen, Novo Nordisk, Xeris, Lilly, BI, Dexcom, Senseonics, Abbott/Bigfoot, Tandem, Insulet, and Medtronic.

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 Partners with Samsung for Smartphone Pump Control

Insulet announced a partnership with Samsung to allow for control of the Omnipod through a Samsung Galaxy smartphone. The specific Samsung device has not been disclosed. Below, FENIX provides thoughts on why a partnership with a single smartphone manufacturer makes sense from a regulatory standpoint.

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 Dexcom Approvals; Dexcom and BD Q3 ’18 Earnings Updates

Dexcom and Becton Dickinson hosted Q3 ’18 earnings calls and provided updates to their respective businesses. Of note, Dexcom discussed two new 510(k) clearances based on the G6 iCGM regulatory pathway. Furthermore, BD said it has discontinued development of the FlowSmart infusion set in favor of other opportunities, notably the T2DM patch pump which is projected to file “in the coming months.” Below FENIX provides thoughts on how Dexcom is anticipated to leverage these new approvals for future product development and market shaping.

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.