Category Archives: Insulin Delivery

JPM 2023 Day 3: ESPR, IONS, EMBC, AMRN, and VTRS

On the third day of JPM 2023, FENIX has provided coverage of presentations by other CVRM companies including Esperion, Ionis, Embecta, Amarin, and Viatris.

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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JPM 2023 Day 2: LLY, ABT, PODD, SNY, AZN, MRK, and GSK; Sernova Advances T1DM Cell Pouch Technology; Pfizer Initiates New Ph1 Oral GLP-1RA Trial

On the second day of JPM 2023, FENIX has provided coverage of presentations by major CVRM companies including Lilly, Abbott, Insulet, AZ, and Merck. GSK and Sanofi also presented at JPM 2023, but neither had any meaningful discussion relating to their respective CVRM portfolios. Separately, two CVRM-related news items have been observed: Sernova announced it has made progress toward a first in-human study for its cell pouch system (view press release); and Pfizer initiated a new Ph1 trial (view CT.gov record) for one of its oral GLP-1RA assets (PF-07081532).

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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Holiday Hangover: Novo’s Wegovy/Ozempic Featured on 60 Minutes; Intercept OCA NASH NDA Refiled; Amgen Initiates Ph2 AMG 133 Obesity Trial; Steven Russell Joins Beta Bionics; Novo’s Third Cagrisema Ph3 Trial Initiated; Wegovy Pediatric Indication; Lannett Bs-Insulin Updates; Equillium and Metacrine Terminate Merger; and More

During the holiday break, a series of cardiometabolic-related news items were observed from Novo Nordisk, Intercept, Amgen, Beta Bionics, Lannett, Equillium and Metacrine, MindRank, EOFlow, Medtronic, Adocia, and PeptiDream. 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.

Medtronic InPen App Recall; Libre 3 + Ypsomed AID Available in Germany; Altimmune Positive Pemvidutide NAFLD Data; Embecta CY Q3 ’22 Earnings Update; Alnylam Submits ALN-KHK CTA for T2DM; Biocorp Receives EU Medical Device Certification

A series of cardiometabolic-related news items have been observed from Medtronic, Abbott, Altimmune, Embecta, Alnylam, and Biocorp. Below, FENIX provides highlights and insight on the respective news items, including thoughts on the Medtronic recall and how the positive Altimmune NAFLD data may not be enough.

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.

Tandem Acquires Sigi Patch Pump; Novo Reports Ozempic Supply Shortages; Novo Initiates Second 7.2mg Sema Ph3 Trial in T2DM; Cytokinetics Host Post-adcom Investor Call

A series of cardiometabolic-related news items have been observed: Tandem announced it entered into a definitive agreement to acquire AMF Medical SA (view press release); it has been reported that Novo Nordisk is experiencing a shortage of Ozempic (view article); Novo Nordisk initiated a second 7.2mg QW SC semaglutide Ph3 trial (view CT.gov record) in T2DM; and Cytokinetics hosted an investor event to discuss the results of the omecamtiv adcom (view press release; webcast). Below, FENIX provides highlights and insights on the respective news items, including questions regarding Tandem’s acquisition decision.

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 Ends Ypsomed Partnership; Cytokinetics Adcom Documents Available

Two cardiometabolic-related news items have been observed: Ypsomed announced Lilly terminated the joint project with Ypsomed to enter the US insulin pump market in 2026 (view press release); and Cytokinetics announced FDA posted briefing documents (view here) for its upcoming omecamtiv adcom which is scheduled for December 13, 2022 (view press release). Below, FENIX provides brief insights on the news items, including how Lilly’s decision to terminate the partnership validates FENIX’s initial thoughts from 2020.

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.

Esperion’s CLEAR Outcomes CVOT Meets Primary Endpoint; Biocorp’s Mallya Receives FDA 510(k) Clearance; Jardiance Meets Primary Endpoint in Pediatric Trial; MediciNova MN-001 (tipelukast) T2DM and NAFLD Ph2 Data; Daewoong Looks to Commercialize Enavogliflozin Globally

A series of cardiometabolic-related news items have been observed from Esperion, Biocorp, BI/Lilly, MediciNova, and Daewoong Pharmaceutical. Below, FENIX provides highlights and insights for the respective news items, including thoughts on the positive clinical data.

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.

Libre 3 + Ypsomed AID Authorized in Germany; Diamyd Ph3 T1DM Clinical Hold Lifted

Two cardiometabolic-related news items have been observed: Ypsomed announced that its mylife Loop is authorized to work with Abbott’s FreeStyle Libre 3 in Germany (view press release); and Diamyd announced FDA lifted the clinical hold on the Ph3 DIAGNODE-3 trial (view press release; view CT.gov record). Below, FENIX provides context and insight 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.

Medtronic CY Q3 ’22 Earnings Update; Novo Expands Manufacturing Facilities; FDA Approves Lilly’s Rezvoglar as an Interchangeable Biosimilar; Oramed Presents Additional Ph2 PRMD-0801 NASH Data

Four cardio-metabolic related news items have been observed: Medtronic hosted its CY Q3 ’22 earnings call (press release; slides); Novo announced plans to invest DKK 5.4B (~$750M USD) in the expansion of manufacturing facilities in Denmark (view press release); FDA approved Lilly’s Rezvoglar (bs-glargine) as an interchangeable to Sanofi’s Lantus (view label; view article); and Oramed hosted an event to discuss data from its Ph2 trial evaluating 8mg ORMD-0801 compared to placebo in 32 participants with T2DM and NASH (slides; webcast; press release). Below, FENIX provides context and insight 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.

Medtronic Launches Extended Wear Infusion Set; Dario Q3 ’22 Earnings Update; Versanis Bio Initiates Ph2 Bimagrumab Study in Obesity

Three cardiometabolic-related news items have been observed: Medtronic announced the US launch of its extended wear infusion set; Dario hosted its Q3 ’22 earnings call and provided updates on its digital health portfolio (press release); and Versanis Bio has initiated a Ph2 trial evaluating the safety and efficacy of Q12W bimagrumab monotherapy or in combination with semaglutide in overweight or obese patients (view CT.gov record). 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.

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.