Tag Archives: trulicity

REWIND Receives Positive CHMP Opinion

Lilly announced that CHMP issued a positive opinion for a Trulicity CV indication based on results from the REWIND CVOT. Below, FENIX provides thoughts on the impending Trulicity EU label update as well as potential readthrough to the ongoing FDA regulatory review.

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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REWIND CHMP Opinion This Week?; Dapa/Saxa/Met Opinion Anticipated (CHMP Agenda Sept 16-20)

The CHMP agenda for this week’s meeting (September 16-20) has been released, and it includes two notable items (REWIND and dapa/saxa/met triple FDC opinions). Below, FENIX provides diabetes-related highlights and insights from the CHMP agenda.

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 Standards of Care Update: REWIND, CGM TIR Targets, and Victoza Peds

Yesterday, ADA announced updates to its Living Standards of Medical Care in Diabetes. The Living Standards of Care revision now incorporates REWIND CV data, Victoza use in pediatric patients, and the international consensus report on CGM time-in-range goals. Below, FENIX provides thoughts and market implications for each of the respective guideline 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.

No Update on REWIND CHMP Decision

A CHMP opinion on Lilly’s REWIND CVOT was anticipated on Friday, July 26; however, there has been no press release from Lilly nor is REWIND listed on the July 2019 CHMP meeting highlights. Below, FENIX provides brief thoughts on the REWIND EU regulatory situation.

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.

REWIND CHMP Decision This Week; CHMP Agenda Highlights

The CHMP agenda for this week’s meeting has been released, and it includes eight notable items of which Lilly’s REWIND is likely the most significant. Below, FENIX provides diabetes-related highlights and insights from the CHMP agenda.

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 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.

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.