Tag Archives: FDA

FDA Issues Warning Letters for Misleading Pharmaceutical Advertising; Veru Initiates Enobosarm Ph2b PLATEAU Study; Vanda Initiates Tradipitant Ph3 Study

Three cardiometabolic-related news items have been observed: FDA issued warning letters for illegal marketing of compounded GLP-1RAs (view press release; view letters) and warned Novo over Ozempic ad (view article; view letter); Veru initiated the Ph2b PLATEAU study of enobosarm (selective androgen receptor modulator) for obesity (view CT.gov record); and Vanda Pharmaceuticals initiated the Ph3 tradipitant trial for the treatment of nausea and vomiting induced by GLP-1RA use (view CT.gov record).

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 Biocon’s Generic Saxenda; Novo Partners for Oral Peptide Development; Medtronic Launches MiniMed Go in EU; Bloom Doses First Patient in Ph1 Obesity Trial; BreezeBio Raises $60M in Series B; Verdiva Completes Ph2b Obesity Enrollment; MHRA Raids Illegal Manufacturing Facilities in UK

A series of cardiometabolic-related news items has been observed from Biocon, Novo Nordisk, Medtronic, Bloom Science, Verdiva Bio, and MHRA. 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

You can read the article’s full content online after purchase.

Novo Reduces Semaglutide WAC Prices; Pfizer To Commercialize Ecnoglutide in China; Novo Ph2 GGG data; AbbVie Builds Out Obesity Manufacturing; Fortress Sells PRV; Alveus Closes $197M Series A; Beta Bionics FDA Warning Letter; Hims & Hers Q4 ’25 Earnings

A series of cardiometabolic-related news items has been observed from Novo Nordisk, Sciwind Biosciences/Pfizer, AbbVie, Fortress Biotech, Alveus Therapeutics, Beta Bionics, and Hims & Hers. 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.

Lilly Launches Zepbound KwikPen; Allurion Gains FDA Approval; Eversense 365 Launches with twiist AID System; February CHMP Agenda

A series of cardiometabolic-related news items has been observed from Lilly, Allurion Therapeutics, Sequel Med Tech/Senseonics, and EMA. 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.

Beta Bionics and Insulet Q4 ’25 Earnings; Lilly Taltz+Zepbound PsO Combination Data; Zealand Ph1a Kv1.3 Inhibitor Topline Results

A series of cardiometabolic-related news items has been observed from Beta Bionics, Insulet, Lilly, and Zealand Pharma. Below, FENIX provides highlights and insights on 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 Retatrutide Risk Mitigation; Medtronic CY Q4 ’25 Earnings; 7.2mg Wegovy EU Approval; Lilly Targets India for Manufacturing Hub; EC Approval of Myqorzo; Esperion and Alkem Reach Generic BA Agreement

A series of cardiometabolic-related news items has been observed from Lilly, Medtronic, Novo Nordisk, Cytokinetics, and Esperion Therapeutics. 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.

Novo and Hims Compounding Saga Concludes?; Obesity Spotlighted in the Super Bowl; Lilly Registers ENLIGHTEN-6 Eloralintide Study; MannKind Initiates Afrezza New Onset T1DM Trial

A series of cardiometabolic-related news items has been observed from Novo Nordisk/Hims & Hers, Super Bowl LX, Lilly, and MannKind. Below, FENIX provides highlights and insights on 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 Super Bowl Ad; FDA Takes Stance on Compounding; Arrowhead Q4 ’25 Earnings

Three cardiometabolic-related new items have been observed: Novo Nordisk published its Wegovy Pill Super Bowl LX commercial (view press release); Marty Makary took a stance against compounders on X (view article; view post); and Arrowhead Pharmaceuticals hosted its Q4 ’25 earnings call (view press release). Additionally, TrumpRx (view here) has been officially launched, and FENIX will conduct an in-depth analysis early next week. 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.

Hims Launches Compounded Sema Pill; Novo London, AbbVie, GSK, and Novartis Q4 ’25 Earnings; Stelo Smart Meal Logging Updates; Abbott FDA Warning Letter and Class I Recall; Rare Pediatric PRV Program Reauthorized; Sciwind Ph3 OSA Study

A series of cardiometabolic-related news items has been observed from Hims & Hers, Novo Nordisk, AbbVie, GSK, Novartis, Dexcom, Abbott, the White House, and Sciwind Biosciences. 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.

Novo Initiates Two Cagrisema Formulation/Device Trials; Lilly Initiates Third Ph3 Eloralintide Trial; FDA Approves Zepbound Kwikpen; Roche Increases Investment for Obesity Manufacturing Site; Abbott Q4 ’25 Earnings; CORXEL Closes $287M Series D1 Funding; Sesame Partners with Novo for Wegovy Pill

A series of cardiometabolic-related news items has been observed from Novo Nordisk, Lilly, Roche, Abbott, Corxel Pharmaceuticals, and Sesame. 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.