Category Archives: GLP-1RA

EASD Key Press Releases (Oct 5)

On the fourth day of EASD 2023, seven key news items were observed from BI/Zealand, Novo Nordisk, Fractyl, Sernova, Dexcom, and Biomea. The following topics are covered below (hyperlinks to external 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.

EASD Key Press Releases (Oct 4)

On the third day of EASD 2023, four key news items were observed from Lilly, Vertex, Phillips-Medisize, and Welldoc. The following topics are covered below (hyperlinks to external 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.

EASD 2023 Key Press Releases (Oct 03)

On the second day of EASD 2023, three key news items were observed from the Biden-Harris administration, Novo Nordisk, and Galectin Therapeutics. The following topics are covered below (hyperlinks to external 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.

Structure Announces Positive Topline Results from Ph1b Oral GLP-1RA Study; Better Therapeutics Completes Enrollment of AspyreRX Clinical Program in T2DM; Madrigal Commences $500M Public Offering

Three cardiometabolic-related news items have been observed: Structure Therapeutics announced positive topline results from its Ph1b MAD study evaluating QD doses of GSBR-1290, its oral GLP-1RA, in healthy overweight or obese individuals and provided updates regarding its GSBR-1290 development program (view press release); Better Therapeutics announced it completed enrollment of the AspyreRx clinical program to provide cognitive behavioral therapy for adults with T2DM (view press release); and Madrigal announced it commenced its $500M public offering in shares of its common stock and pre-funded warrants (view press release). Below, FENIX provides highlights and insights into the respective 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.

Ozempic Label Update; AZ, BMS, Merck, and BI to Participate in Medicare Price Negotiations; FDA and Health Canada Clear Expansion Portion of Biomea’s Ph2 Oral Menin Inhibitor Trial in T2DM

Three cardio-metabolic related news items have been observed: FDA updated the Ozempic label to include ileus (intestinal blockage) as an adverse reaction reported post-approval (view updated label); AZ, BMS, Merck, and BI have reportedly agreed to participate in the first round of Medicare price negotiations (view article); and Biomea Fusion announced FDA and Health Canada cleared the expansion portion of its Ph2 COVALENT-111 study evaluating BMF-219, an oral covalent menin inhibitor, in T2DM (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.

Rockley Photonics Progresses Non-Invasive, Optical Blood Glucose Monitoring; Intercept to be Acquired by Alfasigma; EMA to Discuss GLP-1RA-Associated Aspiration Risks; Kallyope Initiates Ph2 trial of Oral Obesity and T2DM Treatment

Four cardiometabolic-related news items have been observed: Rockley Photonics announced it is continuing to make progress on non-invasive glucose sensing with its wearable silicon photonics-based sensor (view press release); Intercept announced it has entered a definitive agreement to be acquired by Alfasigma (view press release); EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will reportedly be discussing aspiration-related risks associated with GLP-1RAs in its September 2023 meeting (view article); and Kallyope announced it initiated a Ph2 trial evaluating K-757 and K-833, oral nutrient receptor agonists, for the treatment of obesity and T2DM (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.

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.

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.

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.