Category Archives: Topics

Invokana CV Indication Delayed 3-Months by FDA

Janssen announced FDA has extended the CANVAS/R sNDA review by 3 months with a new action date in October 2018. According to the press release, FDA requested the extension after receiving additional analyses from Janssen. Recall, BI/Lilly had a similar 3-month delay after FDA asked for additional data from the EMPA-REG OUTCOME study.

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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Sanofi/Verily Connected Care Partner Acquired by German Device Manufacturer

Sensile Medical is reportedly being acquired by Gerresheimer, a German company specializing in manufacturing packaging and drug delivery systems.

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.

Albiglutide CVOT to be Presented at EASD 2018

The EASD 2018 congress schedule has been posted and, interestingly, results from the albiglutide (Tanzeum/Eperzan) CVOT, HARMONY Outcomes, is being presented on Tuesday, October 2 at 12pm local time. Below is an overview of the topics and presenters.

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 New Dexcom G6 T2DM Basal-Only Study (MOBILE)

A new trial (MOBILE) evaluating Dexcom’s G6 CGM vs. SMBG in 207 T2DM patients has been observed. With this trial, Dexcom appears to be moving beyond “intensive insulin-using T2DM” patients and into “basal-only,” which is a considerably larger market opportunity. Below, FENIX provides further details into the study design as well as thoughts on how Dexcom may utilize these results for expanding the G6 CGM eligible population.

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.

BI/Lilly Sign Jardiance Outcomes-Based Contract with Highmark

BI/Lilly and Highmark have entered into an outcomes-based contract (OBC) for Jardiance focusing on the “total cost of care for adults with type 2 diabetes and established cardiovascular disease who have been prescribed Jardiance, compared with people who have not been prescribed Jardiance.” Below, FENIX provides insight and context for recent diabetes-related OBCs.

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/UHC Value-Based Contract Results

Medtronic has announced first year results from its UHC value-based contract. Medtronic initially discussed these results during the 2018 ADA analyst briefing (previous FENIX insight).

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.

Senseonics to integrate with Glooko

Senseonics has announced a global partnership with Glooko, allowing for integration of the Eversense implantable CGM with Glooko’s diabetes data management platform. Under the partnership, Eversense data can be synced to the Glooko platform directly from the Senseonics cloud, allowing both users and HCPs to access historical glucose and related data. Below, FENIX analyzes the value of this partnership for Senseonics.

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.

Former Lilly Exec Thane Wettig Joins Intarcia As New Head of Marketing

Intarcia announced it has appointed Thane Wettig (pictured below) as the new Chief Marketing Officer and Metabolic Franchise Head.

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 New Sanofi/Verily Connected Care Pre-filled T2DM Pump Partnership

With Sanofi and Verily’s recent Sensile Medical partnership for a connected pre-filled patch pump (Sensile website), FENIX has conducted an analysis of Sanofi’s connected care strategy with market, manufacturing, and payer implications. Below, FENIX provides insight into the diabetes connected care landscape in the context of the large insulin manufacturers (Sanofi, Novo, and Lilly).

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.

EMPA-REG hHF and Renal Data Added to EU Jardiance Label

Boehringer Ingelheim and Lilly announced that Jardiance and its FDCs have received a positive CHMP opinion and label updates for the reduction of hospitalization for heart failure (hHF) and new-onset or worsening kidney disease. Interestingly, the EU label updates are based on data from the EMPA-REG OUTCOME study “due to the current unmet medical need to treat these conditions.” Below, FENIX discusses potential read-through from the precedence set by FDA for previous Pradaxa label 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.

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.