Tag Archives: Lilly

FDA Publishes Slew of CRLs in Effort to Increase Transparency

FDA announced it has published more than 200 CRLs to increase transparency. The CRLs were issued to applications submitted between 2020 and 2024, and all are for drugs that have since gained approval from the agency, a Department of Health and Human Services spokesperson told Fierce Biotech (view article). Below, FENIX provides an overview of select CRLs and brief insight into the FDA openness policy.

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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Sernova and Eledon Partner for T1DM; Lilly’s Zepbound KwikPen Approved in Canada; Altimmune Enrolls First Patients in Ph2 ALD Study; MetaVia Doses First Patient in Ph1 Obesity Study

A series of cardiometabolic-related news items have been observed from Sernova Biotherapeutics/Eledon Pharmaceuticals, Lilly, Altimmune, and MetaVia. 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.

Viking Initiates its Ph3 Study for VK2735; Rivus Shares Topline Ph2 Data in MASH; Lilly Initiates New Ph2 Study of Naperiglipron in Obesity and Ph3 Study of Retatrutide in CLBP; Letter to FDA Pushing for T1DM Treatments; MindRank Announces Ph2b Data for its Oral GLP-1RA 

A series of cardiometabolic-related events has been observed from Viking Therapeutics, Rivus Pharmaceuticals, Lilly, FDA, and MindRank. 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.

ADA 2025 Key Press Releases (June 23)  

On the final day of the ADA 2025 conference, six cardiometabolic-related news items have been observed from Amgen, Novo Nordisk, Lilly, Lexicon Pharmaceuticals, and Terns Pharmaceuticals. Of note, Amgen is hosting an investor call discussing the MariTide Ph2 results, and FENIX will provide updated thoughts after the team heads back from Chicago, including a benefit/risk analysis of conducting a H2H trial vs. tirzepatide. Below, FENIX provides context and analysis for the announcements.

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 ADA 2025 Investor Event; Efsitora Alfa QW Insulin Ph3 Data

Lilly hosted its ADA 2025 investor call and provided updates across its obesity portfolio, including orforglipron, retatrutide, and other early pipeline assets (view webcast). Lilly separately announced the presentation of Ph3 QW insulin efsitora alfa data (view press release). Of note, Ken Custer, Lilly’s new BU head for Cardiometabolic Health (previous FENIX insight), presented to investors for the first time. Below, FENIX provides an overview of the Lilly ADA investor event.

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.

ADA 2025 Key Press Releases (June 21)  

On the second day of the ADA 2025 conference, six cardiometabolic-related news items have been observed from Lilly, Novo Nordisk, Vertex Pharmaceuticals, Senseonics, Medtronic, and Corxel Pharmaceuticals. Below, FENIX provides context and analysis for the announcements.

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 Commissioner Comments on T1DM at BIO Conference; Lilly Acquires Verve Therapeutics; Metsera Ph1/2 Amylin Trial; Medtronic Invests in India; Allurion Shares Data at ASMBS 

A series of cardiometabolic-related news has been observed from FDA, Lilly/Verve, Metsera, Medtronic/MiniMed, and Allurion Technologies. 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 Expands Zepbound SDVs; Ph1 Lilly Amylin Results; D&D Ph2 Obesity Data; MBX Submits IND for Obesity Asset; June CHMP Agenda 

A series of cardiometabolic-related news items have been observed from Lilly, D&D Pharmatech, MBX Biosciences, 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.

Novo Signs Two Obesity Drug Development Partnerships; Lilly Enters Research Collaboration for Muscle Preservation Drug Discovery; Lilly Takes Stance Against Compounders 

A series of cardiometabolic-related news items have been observed from Novo Nordisk 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.

Welldoc Supports Launch of New Lilly Health App; NodThera Initiates Ph2 Study of NT-0796; Virta Claims Cost Savings for Obesity Programs 

Three cardiometabolic-related news items have been observed: Welldoc announced it will power Lilly’s new app for obesity  (view press release); NodThera initiated its Ph2 RESOLVE-1 study for NT-0796 in obesity (view press release); and Virta Health announced cost savings for health plans and employers utilizing its cardiometabolic programs (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.