Category Archives: Basal Insulin

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.

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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.

Novo Q1 ’19 London Earnings Update

Novo Nordisk hosted its post-Q1 ’19 earnings event in London. The session included a brief presentation from management followed by Q&A. Below, FENIX provides highlights and insights 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.

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.

Tresiba Hypo Benefit Over Toujeo; Novo Q1 ’19 Earnings Update

Novo Nordisk hosted its Q1 ’19 earnings call (press release) and provided updates to its diabetes business including the recent oral semaglutide and Ozempic regulatory filings. Of note, Novo reported topline results from the Tresiba vs. Toujeo H2H trial. Below, FENIX provides highlights and insights from the call including thoughts on how the Tresiba vs. Toujeo H2H trial may impact the basal 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.

REWIND Filed; Empa T1DM, Nasal Glucagon Delayed; Lilly Q1 ’19 Earnings Update

Lilly hosted its Q1 ’19 earnings call and provided updates to its diabetes business. Of note, Lilly disclosed that it submitted REWIND (US and EU), URLi (EU, Japan, and maybe the US), a connected prefilled pen (US), and the empa+lina+metXR triple combination (US). Furthermore, Lilly also disclosed two regulatory delays. FDA refused to accept the sNDA for Jardiance in T1DM for “technical reasons,” and the review for Lilly’s nasal glucagon rescue product was extended by 3 months after FDA requested additional data. Below, FENIX provides thoughts and context to the significant Q1 ’19 regulatory events in diabetes.

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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Sign UpFREE

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Biocon CY Q1 ’19 (FY Q4 ’19) Earnings Update

Biocon hosted its CY Q1 ’19 (FY Q4 ’19) earnings call and briefly discussed its biosimilar insulin program including bs-glargine and bs-aspart. Below, FENIX provides highlights and insights 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.

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.