Tag Archives: Diabetes

CARMELINA CVOT Neutral; No Mention of Superiority

Boehringer Ingelheim and Lilly have announced topline results from CARMELINA, the Tradjenta CVOT, which demonstrated no increased CV risk. BI/Lilly did not discuss whether or not CARMELINA met superiority, but it is assumed the trial was neutral given results from the other DPP-IVi CVOTs. Below, FENIX provides insight into the results including implications from the pre-specified superiority testing plan.

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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Novartis Discontinues LIK066 in obesity; Novartis and Abbott Q2 ’18 Earnings Updates

Novartis and Abbott both held their respective earnings calls today and provided updates to their respective commercial and pipeline products. Of note, Novartis disclosed it has discontinued development of LIK066 (dual SGLT1/2 inhibitor) for the treatment of obesity. Abbott believes it will be able to reach 1 million global Libre users by YE ’18. Below are highlights from the respective Q2 ’18 earnings calls.

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

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Thoughts on CREDENCE

CREDENCE was recently stopped early, bringing a multitude of thoughts and potential implications to the diabetes market. Below, FENIX provides deep, rich analysis on the potential results of CREDENCE, the possibility for CREDENCE to be in a combined FDA review with CANVAS/R, market and label implications, read-through to DECLARE, and how ARB history seems to be repeating itself with SGLT2i.

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

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J&J Q2 ’18 Earnings Update

J&J hosted its Q2 ’18 earnings call and provided brief updates on its diabetes business. Importantly, senior management did not make any comments regarding the early stopping of the CREDENCE study or the delay in the CANVAS/R CV indication. Below are highlights from the Q2 2018 J&J earnings call.

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 CeQur/Calibra Acquisition and T2DM Patch Pump Market

CeQur announced it has acquired global rights to commercialize the OneTouch Via patch pump. CeQur’s interest in OneTouch Via is curious since CeQur has developed its own patch pump (PaQ). According to the press release, CeQur plans to launch the OneTouch Via (branded under a new, undisclosed name) in mid-2019. Below, FENIX provides thoughts on whether CeQur will commercialize both devices as well as insight into the T2DM pump 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.

Invokana Renal Outcomes Study (CREDENCE) Stopped Early

Janssen announced its Invokana renal outcomes study, CREDENCE, has stopped early for overwhelming efficacy. The trial was stopped early based on the recommendation of the Independent Data Monitoring Committee (IDMC) after a planned interim analysis. The news comes ~3 days after FDA delayed approval of Invokana’s CV safety indication.

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 Beta Bionics and Implications to Stable Glucagon, Senseonics, and Fiasp

Beta Bionics has initiated (press release) their home-use clinical trial (CT.gov record)of an insulin-only iLet AP system. Additionally, Ed Damiano, Beta Bionic’s CEO, presented at the Friends For Life conference and provided an update on the iLet commercial device. Below, FENIX provides analysis of the iLet study as well as implications to the glucagon 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.

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.

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.

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.

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.

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.