Tag Archives: insulin

New Novo Insulin Savings Program

Novo Nordisk announced plans to initiate a new US insulin savings program starting on January 2, 2020. Under the new plan, Novo will offer a $99 Cash Card Program for a select volume of any of its insulin analog products as well as the launch of NovoLog and NovoLog Mix Authorized Generics (AG). Below, FENIX provides thoughts on the New Novo insulin program in the context of similar programs by Lilly and Sanofi.

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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Biocon’s Glargine Facility Receives EU GMP Certification

Yesterday, Biocon announced it received EU GMP certification from EMA for its integrated insulin facility in Malaysia, which was inspected in May 2019. Biocon’s Malaysian facility manufactures insulin glargine and rh-insulin. Below, FENIX provides additional thoughts on the EU GMP certification in the context of the recent FDA 483 observations and impending Biocon/Mylan bs-glargine US launch.

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 Legislation to Impact Generic Insulin Approvals

Senators Dick Durbin, Kevin Cramer, and Tina Smith introduced a new bipartisan bill called the Affordable Insulin Approvals Now Act, with the intention to accelerate approvals of generic insulin products. According to the sponsors, the new bill is intended to address the unintended consequence of the 2018 Biologics Price Competition and Innovation Act which created a deadline (March 23, 2020) whereby all pending applications for generic insulin would be automatically rejected. Under the new bill, FDA would be required to continue the reviews of any pending applications. Below, FENIX provides thoughts on the Affordable Insulin Approvals Now Act in the context of the insulins that may be impacted by the March 23, 2020 cutoff date (e.g. Biocon/Mylan bs-glargine, Biocon/Mylan bs-aspart, Sanofi bs-aspart, and Sandoz bs-glargine which was in-licensed from Gan & Lee).

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 U-100 10mL vial FDA approved

According to Drugs@FDA, Novo Nordisk has received US approval for the commercialization of a 10mL vial of Tresiba U-100. Of note, Novo has not received approval for a U-200 vial. Below FENIX provides additional details on the new vial, specifically as it pertains to pediatric use.

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.