Category Archives: Topics

Provention Bio to Resubmit Teplizumab BLA; Novo’s Wegovy Shortage Resolution Appears on Track; Vertex Q4 ’21 Earnings Update

Three cardiometabolic-related news items have been observed: Provention Bio announced plans to resubmit the teplizumab BLA following its Type B pre-BLA resubmission meeting with FDA; It has been reported that Novo’s Wegovy shortage may be resolved by H2 ’22 (view article); and Vertex hosted its Q4 ’21 earnings call (press release; slides). Below, FENIX provides highlights and insights for the respective new 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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Libre 3 Filed as iCGM in US; Abbott Q4 ’21 Earnings Update; FDA Warns Lilly for Misleading Trulicity Instagram Promo

Two cardiometabolic-related news items have been observed: Abbott hosted its Q4 ’21 earnings call (press release; view infographic) where it disclosed it filed the Libre 3 CGM with FDA in 2021; and FDA’s Office of Prescription Drug Promotion (OPDP) has issued a letter to Lilly regarding misleading Trulicity social media post (view OPDP letter here; view Trulicity Promo Materials here). Below, FENIX provides highlights and insights for the respective new 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.

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 Q4 ’21 Earnings Update; Glytec Partners with Nebraska Medicine; Daewoong Pharma Announces Positive Ph3 Enavogliflozin Results in T2DM

Three cardiometabolic-related news items have been observed: J&J hosted its Q4 ’21 earnings call (press release; slides); Glytec announced a strategic partnership with Nebraska Medicine to implement Glytec’s eGlycemic Management System (eGMS); and Daewoong Pharmaceutical announced positive topline results from its Ph3 enavogliflozin program. Below, FENIX provides highlights and insights for the respective new 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.

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.

Jardiance HFpEF Indication Extension Up for Adoption; January 24-27 CHMP Agenda

The CHMP agenda for this month’s meeting (January 24-27) has been released, and it includes one notable item, a potential CHMP opinion for Jardiance HFpEF indication extension, as well as several other agenda items. Below, FENIX provides diabetes-related highlights and insights from the January 2022 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.

FDA Approves Lannett’s Bs-glargine IND; Biocon CY Q4 ’21 (FY Q3 ’22) Earnings Update

Two cardiometabolic-related news items have been observed: Lannett announced FDA has approved the IND application for Lannett’s bs-glargine; and Biocon hosted its Q4 ’21 (FY Q3 ’22) earnings call (press release). Below, FENIX provides highlights and insights for the respective new 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.

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.

Arecor Initiates Ph1 Ultra-Rapid Insulin Trial in T1DM

Arecor Therapeutics announced the initiation of a Ph1 clamp study comparing its ultra-rapid insulin (AT247) to Novolog and Fiasp in T1DM patients (view CT.gov record). Recall, at EASD 2020, Arecor presented an abstract (view here) for a Ph1 study which demonstrated AT247 had a faster onset of glucose-lowering than aspart (17 vs. 50 minutes) and a greater early glucose-lowering effect compared to both aspart and faster aspart (previous FENIX insight). Below FENIX provides brief thoughts on the initiation of the Ph1 trial and Arecor’s diabetes pipeline.

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.

Viatris Recalls One Batch of Non-interchangeable Semglee Prefilled Pens; Dario Hosts 2022 Investor Webinar

Two cardiometabolic-related news items have been observed: Viatris announced a voluntary recall of one Semglee batch due to a potential missing label (view FDA website); and Dario hosted its 2022 Investor Webinar (view presentation replay) to discuss emerging digital health trends for strategic growth in 2022. Below, FENIX provides highlights and insights for the respective new 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.

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 Partners with Abbisko Therapeutics and Evotec; Novo Partners with EraCal Therapeutic; Fractyl Announces Initial Interim Feasibility Data

A series of cardiometabolic-related news items have been observed: Abbisko Therapeutics announced it has entered into a worldwide collaboration and exclusive licensing agreement with Lilly for the development of novel cardiometabolic therapies; Evotec announced a three-year drug discovery collaboration with Lilly for metabolic diseases focusing on kidney diseases and diabetes; EraCal Therapeutics announced a research collaboration with Novo Nordisk for development of anti-obesity pharmacotherapy; and Fractyl Health announced initial interim feasibility data from its open-label REVITA-T2Di trial. Below, FENIX provides highlights and insights for the respective new 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.

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.

Can Michael Davidson Strike Gold Again with NewAmsterdam’s CETPi?

In early January 2022, Michael Davidson’s NewAmsterdam Pharma announced it has dosed the first patient in its Ph3 BROADWAY trial evaluating obicetrapib, a novel cholesteryl ester transfer protein (CETP) inhibitor in patients with HeFH or established ASCVD (view CT.gov record). Below FENIX provides brief thoughts on the NewAmsterdam obicetrapib program in the context of Michael Davidson’s other successful company exits.

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.

JPM 2022 Day 4: Lexicon and Esperion; Imcyse Reports Positive Data from Interim Analysis of Ph2 IMPACT Trial; vTv Therapeutics Provides Update on TTP399 Development; Nemaura Launches Miboko to Employers and Insurers

On the final day of JPM 2022, FENIX has provided coverage of presentations by major CVRM companies including Lexicon and Esperion. Additionally, three separate cardiometabolic-related news items have been observed: Imcyse reported positive biomarker data from an interim analysis of the Ph2 IMPACT trial (view press release); vTv Therapeutics has published a new corporate presentation in which the company disclosed plans to initiate the TTP399 Ph3 program in 2022 (view press release); and Nemaura has launched its Miboko wellness program for employer and payer reimbursement (view press release). Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage.

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.