Tag Archives: Wegovy

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.

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Novo Hires Private Contract Manufacturer for Wegovy Assembly and Packaging; Roche’s Tubeless Patch Pump System Receives 510(k) Clearance; Beta Bionics Introduces iLet Bionic Pancreas; NeuroBo Doses First Patient for Ph2a DA-1241 Study in NASH

Four cardiometabolic-related news items have been observed: Novo Nordisk has reportedly hired PCI Pharma Services to handle Wegovy pen assembly (view article); Roche announced it has obtained 510(k) clearance from FDA for its Accu-Chek Solo micropump system for individuals aged 2 years and older with T1DM (view press release); Beta Bionics posted a video on LinkedIn introducing the iLet Bionic Pancreas in a webinar titled, “Introduction to the iLet Webinar” (view LinkedIn post); and NeuroBo Pharmaceuticals announced the dosing of the first patient in its Ph2a trial evaluating DA-1241, a novel G-protein-coupled receptor 119 (GPR119) agonist for the treatment of NASH (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.

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Purchase Blast$599.00

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Abbott to Acquire Bigfoot; Novo Launches Wegovy in UK; Sernova and Glyscend Appoint New CEOs; SomaLogic Expands Agreement with Novo Through 2025; Novo’s Biocorp Acquisition Updates; Diamyd to Initiate Ph3 DIAGNODE-3 in US

A series of cardiometabolic-related news items have been observed from Abbott, Novo, Sernova, Glyscend, SomaLogic, Biocorp, and Diamyd. Below, FENIX provides highlights and insights for the respective news items. Of note, FENIX will be conducting an in-depth analysis on the Abbott/Bigfoot acquisition in the coming days.

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 Lilly Win Again with Positive STEP HFpEF Full Results

Novo Nordisk announced positive full results from the Ph3 STEP HFpEF trial (view CT.gov record) demonstrating QW semaglutide 2.4mg led to reductions in HF-related symptoms, reductions in physical limitations, and improvements in exercise functions vs. placebo. The full results were presented at the ESC 2023 (August 25-28) conference in Amsterdam, Netherlands, and simultaneously published in the NEJM (view publication). Importantly, Novo stated it anticipates filing for the Wegovy label update in H1 2024 following the completion of STEP HFpEF-DM (view CT.gov record) in participants with HFpEF and obesity with T2DM in Q4 2023. Below, FENIX provides an overview of the STEP HFpEF results as well as thoughts on the impact to the HFpEF treatment paradigm, including potential readthrough to Lilly and other manufacturers looking to enter the obesity market.

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.

Wegovy Faces Supply Shortage in Germany; Abata Announces Novel Pre-clinical Treg Cell Therapy Candidate for T1DM; Bayer Initiates Additional Ph3 Finerenone HF Trials; Merck Initiates Oral PCSK9i CVOT

Four cardiometabolic-related news items have been observed: Novo Nordisk is reportedly having difficulties meeting Wegovy demand in Germany (view article); Abata Therapeutics disclosed its development candidate, ABA-201, to be a disease-modifying Treg cell therapy for T1DM (view press release); Bayer announced it will initiate three additional finerenone Ph3 studies as part of its HF MOONRAKER development program (view press release); and Merck initiated its oral PCSK9i (MK-0616) CVOT (view CT.gov record). 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.

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Purchase Blast$599.00

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

Novo Partners with Thermo Fisher as Second Wegovy Manufacturer; Bayer Initiates New Finerenone HF Study; Welldoc’s BlueStar Receives 510(k) Clearance for CGM-mediated Dose Recommendations

Three cardiometabolic-related news items have been observed: Novo Nordisk has hired Thermo Fisher as its second contract manufacturer for Wegovy (view article); Bayer initiated a Ph3 study evaluating the safety and efficacy of finerenone in patients hospitalized with acute decompensated HF and mildly reduced or preserved LVEF (REDEFINE-HF; view CT.gov record); and Welldoc announced it received its eleventh 510(k) clearance for BlueStar to provide bolus insulin dose recommendations based on CGM data (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.

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Purchase Blast$599.00

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

Novo Q2 ’23 London Earnings; Akero Q2 ’23 Earnings Update

Two cardiometabolic-related news items have been observed: Novo Nordisk hosted its post-Q2 ’23 London earnings call (view webcast); and Akero reported its Q2 ’23 earnings (view press release). Below, FENIX provides highlights and insights from 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

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Novo Nordisk Q2 ’23 Earnings Update

Novo Nordisk hosted its Q2 ’23 earnings call (view press release; slides) and provided updates across its CVRM portfolio, including the recently announced SELECT CVOT topline results, Wegovy supply, and the high-dose oral semaglutide regulatory submission. Importantly, senior management disclosed plans to present full SELECT CVOT results at AHA 2023 in Philadelphia (November 11-13). Below, FENIX provides highlights and insights from the earnings call.

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 and Lilly Win with Positive SELECT CVOT Topline Results

Novo Nordisk announced positive topline results from the SELECT CVOT (view CT.gov record) demonstrating a 20% RRR in 3P-MACE for non-T2DM people with established CVD who were treated with QW 2.4mg semaglutide (Wegovy) compared to placebo. Following the news, Novo’s stock price increased +16%. Novo is anticipated to provide further commentary during its Q2 ’23 earnings call on Thursday, August 10, 2023, at 7:00 AM EST. Below, FENIX provides initial thoughts on the SELECT results, including potential readthrough to Lilly and other manufacturers looking to enter the obesity market.

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.

Afon to Launch Non-Invasive Blood Glucose Sensor in 2024; DEKA ACE Pump Receives 510(k) Clearance; Novo Nordisk Launches Wegovy in Germany; Ionis Completes CARDIO-TTRansform Enrollment

Four cardiometabolic-related news have been observed: Afon Technology is planning to launch a noninvasive blood glucose sensor, called Glucowear, in 2024 (view article); DEKA Research and Development received 510(k) clearance for its DEKA ACE Pump System (view 510(k) decision letter); Novo Nordisk launched Wegovy in Germany without coverage from public health insurance (view article); and Ionis announced the completion of enrollment for its Ph3 CARDIO-TTRansform CVOT of eplontersen in patients with ATTR-CM (view CT.gov record). Below, FENIX provides highlights and insights into the respective news items, including thoughts on who may be interested in commercializing the DEKA pump.

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.