Category Archives: Uncategorized

Zealand Announces Presentation of Preclinical and Clinical Data on ZP8396 and BI 456906; BING Innovations Launches DigiVibe; Dario Signs Remote Patient Monitoring Services Contracts; National Diabetes Awareness Month Activities

A series of cardiometabolic-related news items have been observed: Zealand announced preclinical data for its amylin analog (ZP8396) and clinical data for its GCG/GLP-1 dual-agonist (BI 456906; out-licensed to Boehringer Ingelheim) were presented at The Obesity Society Annual Meeting; BING Innovations announced the launch of DigiVibe to reduce pain associated with SMBG; Dario announced it has signed two new contracts with regional providers for its Remote Patient Monitoring services for patients living with diabetes and hypertension; and Dexcom (view press release), Insulet (view press release), and DaVita (view press release) announced various activities to recognize National Diabetes Awareness Month and World Diabetes Day. 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.

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Novartis’s Entresto Marketing Under DOJ Investigation?; Inventiva’s Ph2a Lanifibranor + Empa Trial (LEGEND); Merck and Sanofi Q3 ’21 Earnings Updates; Roche and Zur Rose Group Collaboration

A series of cardiometabolic-related news items have been observed: It has been reported that Novartis received a request from DOJ regarding details about the marketing and pricing of Entresto since 2016 (view article); Inventiva announced the design of its Ph2a combination (lanifibranor+empa) trial (LEGEND) in patients with NASH and T2DM; Merck (press release; slides) and Sanofi (press release; slides) hosted their respective Q3 ’21 earnings calls; and Roche and the Zur Rose Group announced their collaboration of healthcare products and solutions. 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.

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Purchase Blast$599.00

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Metacrine Discontinues NASH Program; Ikenna Ogbaa Joins GSK to Lead Daprodustat Medical Team; Biocon CY Q3 ’21 (FY Q2 ’22) Earnings Update; Integrity Applications Hires New President and COO

A series of cardiometabolic-related news items have been observed: Metcarine announced it is discontinuing its NASH FXR development program following Ph2a interim results; Ikenna Ogbaa, MD joins GSK to lead daprodustat US medical affairs (view LinkedIn profile); Biocon hosted its Q3 ’21 (FY Q2 ’22) earnings call (press release); and Integrity Applications announced Dr. Paul V. Goode (view LinkedIn) will join the company as the new President and COO. 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.

AZ and Mass Gen Hospital Collaborate with AMAZE Platform; Ionis to Reduce Akcea Workforce by ~70%; Galectin Launches Website for NAVIGATE Trial in NASH; Blue Shield of California Adds Two New Services to Wellvolution Platform

A series of cardiometabolic-related news items have been observed: AstraZeneca announced a collaboration agreement with Massachusetts General Hospital to utilize the AMAZE platform in two pivotal, real-world studies for HF and asthma; Ionis disclosed a reorganization of its Akcea business, including a workforce reduction of nearly 70%; Galectin Therapeutics announced the launch of NAVIGATEnash.com to highlight the Ph2b/3 trial and educate HCPs and patients on liver cirrhosis from NASH; and Blue Shield of California announced the addition of two new services to its Wellvolution platform to provide personalized care and nutrition support for patients with T2DM. 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.

Zealand’s Dasiglucagon Approved; March 22-25 CHMP Agenda; Fractyl Enrolls First Patient in T2DM Study; Twist Bioscience Announces Positive Preclinical Data

A series of cardiometabolic-related news items have been observed: Zealand’s dasiglucagon has been approved in the US as “Zegalogue” for the treatment of severe hypoglycemia in patients 6 years of age and older; the CHMP agenda for this month’s meeting (March 22-25, 2021) has been released; Fractyl announced the first patient has been enrolled in a pivotal trial of Revita DMR; and Twist Bioscience announced positive preclinical data in which its library identified GLP-1R antibodies that demonstrated glucose control. Below, FENIX provides highlights and insights from the respective news items, including thoughts on two potential generic sitagliptin products on the 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.

Bigfoot Recieves $57M in Financing; ACC/Novo Partner for T2DM/CVD HCP Education; Amazon Care Telehealth Program Launched Nationwide

Three cardiometabolic-related news items have been observed: Bigfoot Biomedical announced it has secured combined debt and equity financing of up to $57M for the commercialization of Bigfoot Unity; ACC announced a collaboration with Novo Nordisk to educate HCPs on multidisciplinary care for people T2DM and CVD; Amazon announced the nationwide launch of its Amazon Care telemedicine program. Below, FENIX provides highlights and insight 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.

Insulet to Host Investor Event Following Omnipod 5 Pivotal Data Presentation @ ENDO 2021

Yesterday, Insulet announced that the company will host an investor event on Saturday, March 20, 2021 at 12:30PM EST following the presentation of Omnipod 5 pivotal trial data at the virtual ENDO 2021 conference. According to the ENDO program, Insulet Omnipod 5 pivotal trial data for adults and adolescents will be presented from 11:45-11:55AM EST. Recall, during Insulet’s Q4 ’20 earnings call, senior management stated that they continue to anticipate a US Omnipod 5 commercial launch in H2 ’21.

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.

Glooko Raises $30M Series D; AZ and BrightInsight Launch Digital Platform; Oramed Randomizes 25% of Patients in Ph3 Oral Insulin Trial

Three diabetes-related news items have been observed: Glooko announced it raised $30M in a Series D funding round; BrightInsight announced the launch of AstraZeneca’s AMAZE Disease Management Platform for chronic diseases, including diabetes, heart failure, and CKD; and Oramed announced it has enrolled and randomized 25% of the 675 patients planned for its Ph3 oral insulin trial in T2DM. Below, FENIX provides highlights and insights for the respective news items, including thoughts on Glooko’s Series D being a down round.

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 and Dario Q4 and FY ’20 Earnings Calls; Lilly Research Collaboration for Diabetes; Metacrine Initiates Ph2a Trial in NASH

A series of cardiometabolic-related news items have been observed: Xeris and Dario hosted their Q4 and FY ’20 earnings calls; Lilly announced it entered a research collaboration and license agreement with Biolojic Design for AI drug discovery of an antibody-based diabetes treatment; and Metacrine announced that it initiated a Ph2a trial of MET642 for the treatment of patients with NASH. 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.

Nemaura Q4 ’20 earnings; MET409 POC Data Published in Journal of Hepatology

Two cardiometabolic-related news items have been observed: Nemaura Medical published its CY Q4 ’20 (FY Q3 ’21) earnings update and Metacrine announced the results of the MET409 proof-of-concept study were published in the Journal of Hepatology. 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.