Tag Archives: NA

New Abbott Libre 14-Day Wear, 1-Hour Warm-up and Improved MARD Approved

FDA has approved an extended, 14-day wear time (previously 10-day) for Abbott Freestyle Libre in addition to reducing sensor warm-up time to 1 hour (previously 12 hours). In response to this expanded approval, Dexcom’s stock price dropped ~6% today. Abbott has not issued a press release yet, and the Libre US website is not yet updated. Below, FENIX provides insight into the Libre label update as it relates to the 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.

AZ Q2 ’18 Earnings Update

AZ hosted their Q2 ’18 earnings call and briefly discussed their diabetes portfolio, with particular focus on Farxiga and the upcoming DECLARE CVOT results.

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.

Roche Q2 ’18 Earnings Update

Roche hosted its Q2 ’18 earnings call and briefly discussed its diabetes devices portfolio including Solo micropump, which recently received CE Mark. Importantly, Roche senior management disclosed their intentions to bring the Solo micropump to the US. Below are highlights from the call including insights from Roche’s recent collaboration and investment in Care Innovations.

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.

LLY Dual Agonist Advances to Ph3; Q2 ’18 Earnings Update

Lilly hosted its Q2 ’18 earnings call and provided updates on its marketed and pipeline products. Lilly announced three major pipeline updates including advancement of their QW GIP/GLP-1 agonist to Ph3 after meeting a “high bar” in Ph2 trials, filing of nasal glucagon, and discontinuation of their Ph1 GPR142 agonist. Of further interest, President of Lilly Diabetes, Enrique Conterno, indicated the median follow-up for REWIND would be ~5 years (providing an additional ~1 year for Kaplan-Meier curve separation compared to the 3.8-year median follow-up for LEADER).

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.

Glucagon: Thoughts on Mylan Generic and Novel Launch Timings

The glucagon market for severe hypoglycemia rescue will be evolving in the near future with the anticipated filings of new ready-to-use products from Lilly and Xeris. However, the upcoming Mylan rescue product announced a few months ago will play a significant role in the rescue market ahead of the novel product launches. Below, FENIX provides a rich analysis on the potential timing of the upcoming glucagon rescue entrants from Lilly and Xeris, including also what Mylan’s product may or may not be.

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.

Roche Patch Pump CE Marked

Roche has received CE Mark for the Accu-Chek Solo micropump. Recall, during Roche’s Q4 ’17 earnings call, the company added the Solo micropump to its European launch timeline. The device had been noticeably absent in recent years. In the coming weeks, Roche will initiate a limited pilot launch starting in Austria, Poland, Switzerland, and the UK. Below, FENIX provides insight into the Solo micropump including its potential use in a closed-loop system.

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.

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.

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.

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.

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 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.

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.

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.