Category Archives: GLP-1RA

Adocia Reports Positive BC Lispro Data with Tonghua Dongbao Insulin; January 25-29 CHMP Agenda

A series of cardiometabolic-related news items have been observed: Adocia announced positive results from a BioChaperone Lispro trial using insulin sourced from Tonghua Dongbao; and the CHMP agenda for this month’s meeting (January 25-29, 2021) has been released, and it includes one notable item: EMPEROR-Reduced is on the CHMP agenda but not believed to be up for an opinion. 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.

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.

High-Dose Ozempic Filed with FDA; Andy Ajello Joins Vifor

Novo Nordisk announced it has filed the sNDA for high-dose Ozempic (2.0mg) based on results from the SUSTAIN FORTE trial, which read out in November 2020 (previous FENIX insight). Additionally, Andrew (Andy) Ajello, former Lexicon Commercial Lead and Novo SVP of  US Diabetes/Obesity Sales, has joined Vifor Pharma as the VP of US sales (view LinkedIn profile). Below, FENIX provides thoughts and insights on 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.

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 2021 Day 3: Bayer, Esperion, Precision Bio, Hikma, Vifor; High-dose Oral Sema PIONEER PLUS Trial Posted on CT.gov; Dario Announces Two New Additions to Scientific Advisory Board

On day three of JPM 2021, FENIX has provided coverage of presentations from Bayer, Esperion, Precision Biosciences, Hikma, and Vifor. Additionally, two separate cardiometabolic-related news items have been observed: a CT.gov record has been observed for Novo Nordisk’s PIONEER PLUS trial investigating high-dose oral semaglutide in people with T2DM; and DarioHealth announced Marilyn Ritholz and David Horwitz will be joining the Scientific Advisory Board. 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.

JPM 2021 Day 2: LLY, NVO, ABT, PODD, AMRN, and IONS; Bayer’s Finerenone Receives Priority Review for DKD

On day two of JPM 2021, FENIX has provided coverage of presentations by Lilly, Novo Nordisk, Abbott, Insulet, Amarin, and Ionis. Additionally, one separate cardiometabolic-related news item has been observed: Bayer announced FDA granted priority review of finerenone for patients with DKD. 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.

CORRECTING AND REPLACING: JPM 2021 Day 1: DXCM, MDT, TDOC, NVS; FDA Accepts EMPEROR-Reduced sNDA Without Priority Review; Adocia to Develop Beta Cell Therapy for T1DM Treatment

On the first day of JPM 2021, FENIX has provided coverage of presentations by major cardiometabolic companies including Dexcom, Medtronic, Teladoc, and Novartis. Additionally, three separate cardiometabolic-related news items have been observed: BI/Lilly announced FDA has accepted the Jardiance sNDA for the reduction of HFrEF in patients with and without T2DM; Dexcom and Teladoc announced the pilot launch of the new “CGM-powered insights” feature for Livongo for Diabetes users; and Adocia filed a patent for cell therapy in patients with T1DM. Below, FENIX provides a topline summary of key takeaways by company 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.

Holiday Hangover: FDA Approves First Generic Glucagon; Novo High-dose Sema EU Filing; Novo Extends COVID-19 Relief Program; Eversense Implantable CGM Delayed by FDA; Provention Bio’s Teplizumab Filing Accepted by FDA; Teplizumab July 2, 2021 PDUFA

During the holiday break, a series of diabetes-related news items were observed from Amphastar, Novo Nordisk, Senseonics, and Provention Bio. Below, FENIX provides highlights and insights for 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.

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.

Novo Files Sema 2.4mg Obesity Indication with EMA

Novo Nordisk announced it has filed the MAA for the semaglutide 2.4mg obesity indication in Europe. Recall, Novo filed sema 2.4mg for obesity with FDA on December 4, 2020. Below, FENIX provides additional insight with regard to the European obesity 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.

Novo to Initiate Oral Sema Alzheimer’s Ph3 Program; Novo Ph3 High-dose Rybelsus Trial in 2021; Lilly to Initiate Tirzepatide HFpEF Trial; Highmark and BI Announce Jardiance OBC Results; Medtronic’s Sean Salmon Takes on CV Responsibilities; + Five Other News Items

A series of diabetes-related news items have recently been observed from Novo Nordisk, Lilly, BI/Highmark, Medtronic, Diamyd, Provention Bio, Zealand, and Sensyne Health. Below, FENIX provides highlights and insights for 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.

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 Ph3 Tirzepatide SUPRASS-1 Data Lives up to Ph2b Hype

Lilly announced topline results from the first tirzepatide Ph3 study, SURPASS-1. The study demonstrated up to a -2.1% reduction in A1C and -9.5kg weight loss with 15mg tirzepatide, according to the trial product estimand (e.g. per-protocol analysis). Full results from the SURPASS-1 trial are scheduled to be presented at the ADA 2021 conference (June 25-29). Of note, Lilly has also recently initiated three additional Ph3 studies in the tirzepatide obesity program (SURMOUNT 2, 3, and 4). Below, FENIX provides a SURPASS-1 comparative analysis, including thoughts on tirzepatide in the context of high-dose Ozempic, high-dose Rybelsus, and high-dose Trulicity.

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 Pediatric Exclusivity for Saxenda and Januvia

Two diabetes-related news items have been observed: late last week, FDA approved Saxenda for the treatment of obesity in adolescents (view press release); and FDA issued a press release stating the Januvia franchise has not been proven to improve glycemic control in pediatric patients (ages 10-17) with T2DM (view updated Januvia label). Below, FENIX provides thoughts on how the label updates are anticipated to impact the respective brands.

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.