Tag Archives: Diabetes

Novo Selects First Liver Therapy From Dicerna Collab; Metacrine Initiates Ph2a Jardiance Combo Trial in T2DM/NASH; Terns Pharma Raises $87M in Series C Funding; Dario Announces First Self-insured Employer Client

A series of cardiometabolic-related news items have been observed: Dicerna announced Novo Nordisk selected its first GalXC RNAi candidate for IND-enabling studies in liver-related cardiometabolic diseases; Metacrine announced the initiation of a Phase 2a combination trial of MET409 50g with empagliflozin in patients with T2DM and NASH; Terns Pharmaceuticals announced the closing of its Series C funding round with $87M raised for NASH-related trials; Dario announced an agreement with the first self-insured employer group to come from its partnership with Vitality Group. 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.

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.

Servier Terminates Omecamtiv Agreement; Oramed Oral Leptin PoC Results

Two CV-met news items have been observed: Cytokinetics announced Servier has decided to terminate its sublicense agreement with Amgen for the development and commercialization of omecamtiv in EU and CIS; and Oramed announced topline results from a PoC study of its oral leptin drug candidate. 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.

Xeris Enters Gvoke Distribution Agreement in Israel and Palestine; Dario Partners with Presbyterian Medical Services

Two diabetes-related news items have been observed: Xeris announced an exclusive distribution agreement with Megapharm Ltd. for the commercialization of Gvoke in Israel and Palestine; and DarioHealth announced a partnership with Presbyterian Medical Services to provide patients with chronic conditions access to Dario’s digital therapeutics. 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.

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.

Nemaura Launches BEATdiabetes Program and proBEAT Non-invasive CGM in the US

Nemaura announced the US launch of its BEATdiabetes program and proBEAT non-invasive CGM. Recall, Nemaura’s non-invasive sugarBEAT CGM was originally filed under the wellness category (and launched in the US as proBEAT) for people with T2DM and prediabetes as part of the BEATdiabetes platform. A PMA has been filed for sugarBEAT and Nemaura anticipates FDA approval and a US launch by YE ’21. Below, FENIX provides brief insight on the BEATdiabetes launch in the context of Nemaura as an acquisition target.

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.

UPDATED – Entresto HFpEF Adcom: 12-1 Positive Vote, but End Result Remains Confusing

Content now updated with the Q1 2021 PDUFA date announced in the post-adcom Novartis press release.

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.

Lifescan Launches Online Store with Subscription-based Coaching Services; Welldoc Submits 510(k) with FDA to Expand Insulin Dosing Support; Biocon/Viatris (Mylan) Bs-aspart Receives Positive CHMP Opinion; Poxel Announces Ph2a data from PXL770 in NASH

A series of diabetes-related news items have been observed: Lifescan announced the launch of its OneTouch Store which includes subscription offerings for live diabetes coaching services accessible through the OneTouch Reveal app; Welldoc announced the submission of its 510(k) filing with FDA to expand its insulin dosing support to include bolus and premixed insulin titration for users with T2DM; Biocon/Viatris (Mylan) announced the companies received a positive CHMP opinion for their bs-insulin aspart; and Poxel announced additional results from its Ph2a study of PXL770 in NASH. 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.

Xeris Recieves Positive CHMP Opinion; Roche and Diabeloop Partner for AID Development

Two diabetes-related news items have been observed: Xeris announced it received a positive CHMP opinion for its ready-to-use (RTU) rescue glucagon product, called Ogluo, and Roche announced a partnership with Diabeloop to enhance Roche’s pump hardware platform. 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.