Category Archives: Topics

Tirzepatide Approved in Japan; Nemaura and EVERSANA Partner for BEATdiabetes; SURMOUNT-MMO Trial Record Posted

Three cardiometabolic-related news items have been observed: Lilly announced tirzepatide is approved in Japan (press release); Nemaura announced a preliminary commercialization agreement with EVERSANA for BEATdiabetes (press release); and Lilly’s Ph3 tirzepatide obesity outcomes trial (SURMOUNT-MMO) has been posted on CT.gov (view CT.gov record). Below, FENIX provides highlights and insights from the respective news items.

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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New ADA/EASD 2022 T2DM Guidelines; EASD 2022 Key Press Releases (Sept 23)

On the final day of EASD 2022, two key news items were observed: ADA/EASD presented the updated T2DM consensus guidelines (journal publication; download slides), placing obesity management as a key consideration; and Ionis announced AstraZeneca decided not to advance their PCSK9i (ION449; AZD8233) despite achieving positive Ph2b results (press release). Below FENIX provides insights and context from the respective announcements.

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 Hosts Meet the Management Investor Event

Novartis hosted its 2022 Meet the Management event where the company provided details regarding its new focused strategy, the Sandoz spin-off, and R&D priorities (press release; view slides). Of note, the event was primarily comprised of multiple Q&A sessions. Below, FENIX provides highlights and insights from the event relating to Novartis’s CVRM business.

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.

EASD 2022 Key Press Releases (Sept 22)

On the fourth day of EASD 2022, three key news items were observed from Novo Nordisk, Merck, and Better Therapeutics. Separately, it has been observed that the start date has been delayed for Novo’s first cagrisema Ph3 pivotal trial (Ph3 REDEFINE-2). Below FENIX provides insights and context for the respective announcements.

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.

Pfizer to Advance Oral GLP-1RA Development; Pfizer EASD 2022 Investor Call

Pfizer hosted an EASD 2022 investor event during which the company discussed data for its two oral GLP-1RAs (PF-07081532 and PF-06882961), which were presented at the conference (view slides). For context, PF-07081532 is differentiated from PF-06882961 (danuglipron) as PF-07081532 is a QD oral GLP-1RA compared to danuglipron which is a BID oral GLP-1RA. Below, FENIX provides highlights and insights from the call relating to key commentary from management.

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’s Tempo Smart Button Receives 510(k) Clearance; EASD 2022 Key Press Releases (Sept 21)

On the third day of EASD 2022, three key press releases were observed from Zealand, Carmot Therapeutics, and Abbott. Separately, Lilly’s Tempo Smart Button received FDA 510(k) clearance on September 16, 2022 (view FDA website), although Lilly has not issued a press release. Below FENIX provides insights and context for the respective announcements.

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.

SURMOUNT-MMO Trial Design Presented at EASD 2022

At EASD 2022, Lilly presented a high-level overview of the SURMOUNT-MMO clinical trial design during a session titled “Overcoming challenges in obesity medicine: The SURMOUNT Clinical Development Program” (view session; sign-in required). SURMOUNT-MMO has not yet been posted to CT.gov. Below, FENIX provides an overview of the SURMOUNT-MMO trial design and insights, including key differences with Novo’s SELECT 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.

Insulet Omnipod 5 Receives CE Mark; Novo Nordisk and Octagon Therapeutics Collaboration for Inflammatory Disease Targets; Diamyd Presents Updated 12-month Results from Ph2 GADinLADA Trial; EASD 2022 Key Press Releases (Sept 20)

On the second day of EASD 2022, three key press releases were observed from Insulet, Novo Nordisk, and Diamyd. Below FENIX provides insights and context for the respective announcements.

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.

Biocorp’s SoloSmart receives CE Mark; EASD 2022 Key Press Releases (Sept 19)

On the first day of EASD 2022, Biocorp announced it received CE Mark for SoloSmart, an accessory medical device for Sanofi’s SoloStar/DoubleStar pens that records dose information (e.g., dose amount, time, and date). According to the press release, Biocorp will provide more details regarding the SoloSmart launch during its CY Q3 ’22 earnings call scheduled for September 29th. Below, FENIX provides brief thoughts on the new SoloSmart device as well as potential implications for Novo Nordisk, Lilly, and other insulin pen manufacturers.

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.

Tresiba AG vs. Basal Insulin Pricing Analysis

Recently, Novo announced plans to launch an authorized generic (AG) version of Tresiba (insulin degludec) which will be available in the US in Fall 2022 at a 65% discount to the Tresiba branded list price (previous FENIX insight). Below, FENIX has conducted a pricing analysis of the basal insulin market, including insight into how the market dynamics may be shifting.

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.