Category Archives: Other

Novo Partners with Valo Health for CVD and Evotec for Cardiometabolic Drug Discovery Accelerator; Zucara Doses First Patient in Ph2a ZONE Trial; Merck Initiates Efinopegdutide Study in Hepatic Impairment; Senseonics Completes Adult Arm of ENHANCE Pivotal Study; NeuroBo Posts Ph2 DA-1241 Trial in NASH to CT.gov

A series of cardiometabolic-related news items have been observed from Novo, Zucara, Merck, and NeuroBo. Below, FENIX provides highlights and insights into 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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FDA Approves Jardiance for Adults with CKD; Abbott Completes Bigfoot Acquisition; Insulet Publishes “Market Opportunity & Impact of GLP-1s” Presentation; Lilly initiates Ph3 H2H Orforglipron vs. Semaglutide and New Ph3b Tirzepatide Max Dose Study in Obesity

A series of cardiometabolic-related news items have been observed from BI/Lilly, Abbott, Insulet, and Lilly. Below, FENIX provides highlights and insights into 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.

ITCA 650 Negative Adcom Vote; Medtronic Receives CE Mark for Simplera; 89bio’s Pegozafermin in NASH Receives Breakthrough Therapy Designation; Dexcom Canada Partners with RxFood for Diabetes Management; Novo Nordisk Foundation to Establish New Cell Therapy Facility

A series of cardiometabolic-related news items have been observed from FDA, Medtronic, 89bio, Dexcom, and Novo. Below, FENIX provides highlights and insights into 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.

Ypsomed Signs Long-Term Autoinjector Supply Deal with Novo; Lilly Files Lawsuits Over Copycat Mounjaro Products

Two cardiometabolic-related news items have been observed: Ypsomed announced it has signed a long-term supply agreement with Novo Nordisk to manufacture autoinjectors for various metabolic drugs currently undergoing clinical trials (view press release); and Lilly has recently sued 10 medical spas, wellness centers, and compounding pharmacies for selling unapproved and compounded versions of tirzepatide (view article). Below, FENIX provides highlights and insights into 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.

ITCA 650 Faces Uphill Battle as FDA Releases Adcom Briefing Docs; Novo Receives Form 483 Observations; Abbott and WeightWatchers Launch Connected App Experience

Three cardiometabolic-related news items have been observed: FDA posted briefing documents (view here) for its upcoming ITCA 650 adcom which is scheduled for September 21, 2023; FDA reportedly issued a Form 483 following an inspection of Novo Nordisk’s plant in Clayton, North Carolina (view article); and Abbott and WeightWatchers announced the availability of a connected app that allows PWD to access data from their Libre 2 within their WeightWatchers app (view press release). Below, FENIX provides highlights and insights into the respective news items, including thoughts on the potential outcome of the ITCA 650 adcom.

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 Hires Private Contract Manufacturer for Wegovy Assembly and Packaging; Roche’s Tubeless Patch Pump System Receives 510(k) Clearance; Beta Bionics Introduces iLet Bionic Pancreas; NeuroBo Doses First Patient for Ph2a DA-1241 Study in NASH

Four cardiometabolic-related news items have been observed: Novo Nordisk has reportedly hired PCI Pharma Services to handle Wegovy pen assembly (view article); Roche announced it has obtained 510(k) clearance from FDA for its Accu-Chek Solo micropump system for individuals aged 2 years and older with T1DM (view press release); Beta Bionics posted a video on LinkedIn introducing the iLet Bionic Pancreas in a webinar titled, “Introduction to the iLet Webinar” (view LinkedIn post); and NeuroBo Pharmaceuticals announced the dosing of the first patient in its Ph2a trial evaluating DA-1241, a novel G-protein-coupled receptor 119 (GPR119) agonist for the treatment of NASH (view press release). Below, FENIX provides highlights and insights into 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 Initiates New Ph2 Study Investigating High Doses of Tirzepatide in Patients with T2DM and Obesity; Gan & Lee Doses First Patient in Ph2 QW Insulin Study; BMS discontinues NASH asset

Three cardiometabolic-related news items have been observed: Lilly initiated a Ph2 study to investigate high doses of tirzepatide in patients with T2DM and obesity that are on metformin (view CT.gov record); Gan & Lee announced the first subject has been dosed in its Ph2 study evaluating QW insulin, GZR4, in 130 Chinese adult subjects with T2DM (view press release); and BMS disclosed it is terminating its program evaluating HSP47 in NASH during its R&D day (view article). Below, FENIX provides highlights and insights into 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.

Madrigal Receives Priority Review for Resmetirom NASH NDA; Adipo Therapeutics Appoints Keith Johns as CSO; Novo Nordisk Conducts a Two-for-One Stock Split; Nemaura Announces Interim Miboko Study Results

Four cardiometabolic-related news items have been observed: Madrigal Pharmaceuticals announced FDA accepted the company’s resmetirom NDA for the treatment of adult patients with NASH with liver fibrosis and granted a priority review (view press release); Keith Johns announced he is joining Adipo Therapeutics as the Chief Strategy Officer to continue to advance Adipo as a potential breakthrough treatment for T2DM and obesity (view LinkedIn post); Novo Nordisk announced its Board of Directors approved a split of the trading units of the Novo Nordisk B shares listed on Nasdaq Copenhagen and of the American Depositary Receipts (ADRs) listed on New York Stock Stock Exchange (NYSE) in a two-for-one ratio (view press release); and Nemaura Medical announced interim results from its Miboko metabolic health program with NHS in the UK (view press release). Below, FENIX provides highlights and insights into 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.

Entera Bio to Collaborate with OPKO Biologics for Obesity; Dexcom Launches Dexcom ONE in France; Altimmune Completes Ph2 Obesity Trial Dosing; Vertex Acquires Novel GPCR-targeted Program

Four cardiometabolic-related news items have been observed: Entera Bio and OPKO Biologics entered into a research collaboration agreement for OPKO’s long-acting GLP-2 peptide and certain oxyntomodulin (OXM) analogs (view press release); Dexcom announced Dexcom ONE has been launched in France (with reimbursement) for patients two years of age and older with T1DM and T2DM, who are undergoing intensive insulin therapy (view press release); Altimmune announced the completion of dosing in its 48-week Ph2 MOMENTUM trial, evaluating the safety and efficacy of pemvidutide in patients with obesity or overweight (view press release); and Septerna announced it signed a definitive asset purchase agreement with Vertex for an undisclosed discovery-stage GPCR program (view press release). Below, FENIX provides highlights and insights into 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.

September CHMP Agenda; Nemaura Announces Interim 24-Hour Wear sugarBEAT Results; Madrigal Appoints Bill Sibold as CEO

Three cardiometabolic-related news items have been observed: The CHMP agenda (view here) for this month’s meeting (September 11-14) has been released; Nemaura Medical announced interim results from a 100-patient study across 4 cohorts of 25 (view press release); and Madrigal Pharmaceuticals announced Bill Sibold as the successor to Paul Friedman as CEO (view press release). Below, FENIX provides highlights and insights into 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.