Category Archives: Topics

CHMP Denies Mounjaro OSA Indication; FLOW Positive CHMP Opinion; New Oramed Oral Insulin Study; Diamyd and FDA Align on Accelerated Approval; Noom to Offer Metformin for Weight Loss

A series of cardiometabolic-related news items have been observed from CHMP, Oramed, Diamyd Medical, and Noom. 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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ADA/EASD 2025 Guidelines; Ro/Lilly Zepbound SDV Partnership; Tirzepatide for Addiction Treatment

Three cardiometabolic-related news items have been observed: Updated ADA/EASD guidelines for 2025 have been released (view guidelines; view revisions); Lilly and Ro partnered for Zepbound single-dose vials (view press release); and Lilly announced potential plans for tirzepatide for treatment of addiction and inflammation (view article; view interview). 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.

GLP1-RAs Reduce Blood Clot Risk in T2DM; Zealand Initiates Ph2b Petrelintide Obesity Trial Enrollment; NewAmsterdam Positive CETPi Ph3 HeFH Data

Three cardiometabolic-related news items have been observed: GLP-1RAs reportedly demonstrated potential to decrease venous thromboembolisms (VTEs) in patients with T2DM (view article); Zealand initiated enrollment for the Ph2b ZUPREME-1 trial of petrelintide in obesity (view press release); and NewAmsterdam announced positive topline data from its Ph3 BROADWAY trial of obicetrapib in HeFH (view press release). FENIX will provide an overview of the updated ADA/EASD 2025 guidelines in tomorrow’s blast. 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.

December CHMP Agenda; Senseonics Eversense 365 Launch Updates; BioAge Discontinues Ph2 Obesity Trial

Three cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (Dec 9-12) has been released (view here); Senseonics announced commercial updates to its Eversense 365 launch (view press release); and BioAge announced the discontinuation of its Ph2 obesity trial (view press release). 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.

EC Approves Novo/Catalent Deal; Novo Cuts Insulin Business; Twiist AID Webinar; New Pfizer and Novo Obesity Studies; Lilly CDMO Agreement

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Sequel Med Tech, Pfizer, and Lilly. 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.

UK Tirzepatide Rollout Plan; Lilly and Amgen Expand Manufacturing Facilities; New Novo GLP-1/GIP RA CKD and Obesity Trials; Insulet Defends US Patent from EOFlow

A series of cardiometabolic-related news items have been observed from NICE, Lilly, Amgen, Novo Nordisk, and Insulet. 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.

Zepbound Beats Wegovy in H2H Study; Novavax to Sell Manufacturing Facility to Novo; Antag $84M Series A Financing for Ph1 Obesity Trial

Three cardiometabolic-related news items have been observed: Lilly announced topline data from its SURMOUNT-5 trial where Zepbound was associated with higher weight loss compared to Wegovy (view press release); Novavax is selling a Czech manufacturing facility to Novo Nordisk (view press release); and Antag Therapeutics announced a $84M Series A financing round to support its QW SC GIPR antagonist for the treatment of obesity (view press release). Below, FENIX provides highlights and insights for the respective news items, including thoughts and implications of the H2H Zepbound vs. Wegovy data.

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.

Metsera Initiates Ph2b MET-097 Obesity Trial; Arrowhead Files for Ph1/2a Obesity Trial Initiation; Sanofi Invests in New Beijing Insulin Plant

Three cardiometabolic-related news items have been observed: Metsera initiated a Ph2b MET-097 (SC GLP-1RA) obesity trial (view CT.gov record); Arrowhead Pharmaceuticals filed for regulatory clearance to initiate a Ph1/2a ARO-ALK7 (RNAi) obesity trial (view press release); and Sanofi announced it invested €1B ($1.05B) for a new insulin manufacturing facility in Beijing (view article; view Chinese press release). 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.

Arrowhead CY Q3 ’24 (FY Q4 ’24) Earnings; Embecta Discontinues Patch Pump; New Medicare and Medicaid Obesity Proposal; EOFlow Wins Legal Battle in the EU

Arrowhead CY Q3 ’24 (FY Q4 ’24) Earnings; Embecta Discontinues Patch Pump; New Medicare and Medicaid Obesity Proposal; EOFlow Wins Legal Battle in the EU

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.

Amgen MariTide Ph2 Topline Results; Alnylam sNDA Accepted for Vutrisiran with PRV; Novartis Investor Event

Three cardiometabolic-related news items have been observed: Amgen announced topline 52-week data from its Ph2 MariTide obesity study (view press release); Alnylam announced FDA accepted the vutrisiran sNDA for the treatment of ATTR-CM with a PDUFA date on March 25, 2025 (view press release); and Novartis recently hosted a “Meet the Management” investor day (view press release; CEO presentation; breakout slides). Below, FENIX provides highlights and insights for the respective news items, including thoughts on Amgen’s placement in the obesity treatment paradigm. 

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.