Category Archives: Basal Insulin

Novo ADA 2019 Investor Event Highlights

Novo Nordisk hosted its ADA 2019 investor event immediately following the data readout from Lilly’s REWIND CVOT. Unsurprisingly, Novo compared REWIND to LEADER and SUSTAIN 6. Of note, Novo disclosed plans to initiate its high-dose semaglutide study, SUSTAIN FORTE, in Q2 ‘19. Other topics covered during the call include semaglutide LCM, commentary on Lilly’s tirzepatide, connected pen data, QW basal insulin (LAI287), and more. Below, FENIX provides insights and highlights from the 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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Tidepool Partners with Medtronic and Dexcom; ADA 2019 Key Press Releases (June 7)

Today, four major new items were observed including two new Tidepool partnerships with Medtronic and Dexcom as well as updated Companion Medical InPen features and Monarch Medical’s IOB algorithm 510(k) approval. Of note, the Medtronic/Tidepool partnership is believed to be the first external partnership as part of Medtronic’s notoriously closed diabetes device ecosystem. 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.

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Purchase Blast$599.00

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New Sanofi CEO; Xeris delayed: SENS approval, InPen-Dexcom; Zeal-BB; vTv; Adocia

Today, seven major new items were observed across Sanofi, Dexcom/Companion Medical, Xeris, Senseonics, Zealand/Beta Bionics, vTv, and Adocia. 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.

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ADA ’19 Key Data and Partnership Press Releases (June 5)

Ahead of the ADA 2019 conference start, a series of diabetes-device related press releases have been observed including Companion Medical, Glooko, DreaMed, Roche, CeQur, and Virta Health. 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.

New Bs-Glargine U100 Trial From Lannett

Lannett, a Philadelphia-based generic pharmaceutical company, announced the initiation of a first in-human clinical trial for its biosimilar glargine which is being co-developed through a strategic alliance with YiChang HEC ChangJiang Pharmaceutical Co. (part of the HEC Group of companies). Lannett plans to use the study to support future development with the intent of pursuing approval in the US. Below, FENIX provides insight into the Lannett bs-glargine and thoughts on how the recent FDA guidance on biosimilar interchangeability may have been a catalyst for its development.

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.

New Novo QW Insulin Ph1 and Ph2 Studies

Novo Nordisk recently initiated three new studies (two Ph2 and one Ph1) for its QW basal insulin (LAI287). The Ph2 studies are separately evaluating strategies to initiate and titrate LAI287 while the Ph1 trial is helping to further characterize the PK/PD profile with a crossover with glargine U100. Below, FENIX provides insights about the new LAI287 trials including thoughts how these trials are helping to answer logistical questions surrounding a potentially first-in-class QW insulin.

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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FENIX Analysis: Insulin Promotional Materials Post-AACE 2019

In the third installment of our post-AACE 2019 promotional material coverage, FENIX has conducted an analysis of insulin promotional materials covering all of the major brands including Tresiba, Lantus/Toujeo, Basaglar, Humalog, Admelog, Afrezza as well as the basal+GLP-1 fixed-ratio combinations (Xultophy and Soliqua).

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 Warns Against DIY Closed-Loop Systems

FDA issued a safety communication regarding the use of unauthorized devices as part of closed-loop systems. Additionally, FDA said it has identified companies who are “illegally marketing components, such as unauthorized continuous glucose monitors that some patients may integrate into unauthorized automated insulin dosing systems.” According to the FDA communication, the warning is based on a report that a patient received too much insulin resulting in the need for medical intervention. Below, FENIX provides insight on the FDA communication including the potential impact on current closed-loop systems in development as well as thoughts on potential systems that are being marketed illegally.

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 Issues Final Guidance on Biosimilar Interchangeability

Late last week, FDA issued the final guidance on biosimilar interchangeability titled, “Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry.” Below, FENIX provides thoughts on the FDA interchangeability guidance in the context of the insulin 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.

ADA 2019 Abstract and Session Titles Available

ADA 2019 abstract and session titles are available through the ADA desktop app. According to the ADA website, full abstract text will be available Tuesday, June 4 at 5:00 pm ET.

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.