Category Archives: Dual/triple agonist

FDA Tirzepatide Shortage Removal Update; Catalent Sells Site to Ardena; LifeVantage Launches MindBody GLP-1 System; Inventiva Receives Additional Funding for MASH; October CHMP Agenda; Sagimet Publishes FASCINATE-2 Data; Q Bio Appoints Jeff Brewer as CEO

A series of cardiometabolic-related news items have been observed from FDA, Catalent/Ardena, LifeVantage Corporation, Inventiva, EMEA, Sagimet Biosciences, and Q 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.

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Senator Warren Calls for Novo/Catalent Block; Lilly Sends Cease-And-Desist to Compounding Pharmacies; Lilly and KeyBioscience Continue Obesity Collaboration

Three cardiometabolic-related news items have been observed: Senator Warren sent a letter to FTC to block Novo’s Catalent acquisition (view letter); Lilly sent cease-and-desist letters to compounding pharmacies to stop the sale and manufacture of non-branded tirzepatide (view article); and Lilly and KeyBioscience announced the extension of their DACRA development collaboration in obesity (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.

Zealand Receives Second CRL; Lilly Partners for Drug Discovery and Peptide R&D; Alnylam Submits Vutrisiran sNDA; BI Initiates Two Survodutide Trials

A series of cardiometabolic-related news items have been observed from Zealand Pharma, Lilly, Alnylam Pharmaceuticals, and Boehringer Ingelheim. 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.

BI Receives BTD for Survodutide and Initiates 2 Ph3 MASH Trials; Roche Ph2 CT-388 Trial in Obesity+T2DM; Drug Compounder Group Sues FDA; WeightWatchers to Offer Compounded Semaglutide; Novo Invests $158M in Insulin Plant

A series of cardiometabolic-related news items have been observed from Boehringer Ingelheim, Roche, the Outsourcing Facilities Association, WeightWatchers, and Novo Nordisk. 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.

FDA Removes Tirzepatide from Shortage List

FDA announced the tirzepatide shortage has been resolved and provided clarifications for compounding manufacturers. According to the announcement, FDA confirmed with Lilly that their stated product availability and manufacturing capacity can meet the present and projected national demand. However, patients and prescribers may still see intermittent localized supply disruptions as the products move through the supply chain from Lilly and distributors to local pharmacies. Below, FENIX provides brief insight into the impact of the FDA announcement.

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.

Eversense 365 Launched in US; Kailera Launches as Obesity Biotech; Lilly Funds New $4.5B Indiana Facility

Three cardiometabolic-related news items have been observed: Ascensia Diabetes Care announced the launch of the Eversense 365 CGM in the US (view press release); Kailera Therapeutics announced its launch as a biotech with an asset in Ph3 development for the treatment of obesity (view press release; view article); and Lilly announced a $4.5B investment to create a new R&D and manufacturing facility in Lebanon, Indiana (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.

Metsera Partners with Amneal for Obesity Manufacturing; Rivus Obesity Data at HFSA 2024; Sagimet Receives BTD for Denifanstat; Biomea Establishes Scientific Advisory Board; Madrigal Appoints New SVP

A series of cardiometabolic-related news items have been observed from Metsera/Amneal Pharmaceuticals, Rivus Pharmaceuticals, Sagimet Biosciences, Biomea Fusion, and Madrigal Pharmaceuticals. 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.

Roche Pharma Day; Rezdiffra QoL Publication; Pemvidutide Trial Enrollment Updates; NeuroBo Ph1 Obesity Readout; MannKind Afrezza Data

A series of cardiometabolic-related news items have been observed from Roche, Madrigal, Altimmune, NeuroBo, and MannKind. 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.

Galmed MASH Open-Label Publication; Entera/OPKO GLP-1/GCG Pre-Clinical Update

Two cardiometabolic-related news items have been observed: Galmed published one-year open-label results from its Ph3 MASH study (view press release; view publication); and Entera Bio and OPKO Health provided updates on its preclinical oxyntomodulin asset in obesity (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.

Metsera Reports Positive Ph1 Obesity Topline Results; Novo CEO Testifies at Senate HELP Committee Hearing

Two cardiometabolic-related news items have been observed: Metsera announced positive topline results from its Ph1 clinical trial of MET-097, its ultra-long-acting injectable GLP-1RA (view press release); and Novo Nordisk’s CEO, Lars Fruergaard Jørgensen, testified at the Senate Committee on Health, Education, Labor, and Pensions (HELP) hearing titled, “Why Is Novo Nordisk Charging Americans with Diabetes and Obesity Outrageously High Prices for Ozempic and Wegovy?” (view broadcast here). Below, FENIX provides insight into Metsera’s first obesity data readout as well as initial thoughts on the Senate HELP committee hearing.

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.