Category Archives: Basal Insulin

Biocon’s Malaysian Facility Passes Pre-Approval Glargine FDA Inspection

Biocon has issued a press release announcing they received the FDA “Establishment Inspection Report” for the bs-glargine pre-approval inspection of its Malaysian manufacturing facility. The closing of the inspection comes after several failed inspections over the past few years. Below, FENIX provides thoughts on Biocon passing its inspection, including the impact on the impending June 2020 bs-glargine FDA action date.

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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Nemaura enters into multiple non-binding agreements for sugarBEAT; Mylan wins over Sanofi in Lantus patent litigation

A series of diabetes-related news has been observed including an announcement that Nemaura has entered into multiple non-binding agreements for its sugarBEAT CGM (press release) as well as the US District Court ruling favorably for Mylan/Biocon’s bs-glargine over Sanofi’s Lantus (press release). Below, FENIX provides brief thoughts on these announcements in the context of the recent news from Nemaura and the potential launch of Mylan/Biocon’s bs-glargine.

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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Mylan Q4 ’19 Earnings Update; Bs-glargine Briefly Discussed

Mylan hosted its Q4 and FY 2019 earnings call and provided updates to its business. The vast majority of the call revolved around the pending merger with Pfizer’s Upjohn. Of note, Mylan briefly discussed the US regulatory status of its bs-glargine and bs-aspart (in partnership with Biocon). 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.

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Purchase Blast$599.00

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

Oramed Oral Insulin Ph2b Cohort B Results

Oramed announced positive topline results from Cohort B of the Ph2b trial evaluating its oral insulin (ORMD-0801) in T2DM patients. Oramed also hosted an associated call with investors to discuss the results. Recall, Oramed announced results from Cohort A of this Ph2b study in November 2019, which demonstrated a statistically significant result for the QD and BID doses but not with the TID dose (previous FENIX insight). Below, FENIX provides highlights of the new data and brief thoughts in the context of the previous Ph2b results, Tresiba’s CVOT (DEVOTE), and Novo’s QW basal insulin (icodec).

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.

Biocon Insulin Manufacturing Facility Fails Another FDA Inspection

Biocon issued a press release stating it received a Form 483 with three observations following an FDA inspection (Feb 10-21) of its Malaysian manufacturing facility. The deficiencies were noted by FDA during the pre-approval inspection for the company’s biosimilar glargine. Recall, during Biocon’s recent earnings call, Biocon disclosed FDA has set an action date in June 2020. Below, FENIX provides brief thoughts on the failed inspection and how it could impact US commercialization of its bs-glargine product.

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.

First Look at Sanofi’s Connected Insulin Pen Solutions?

During the ATTD 2020 conference, a slide was presented with what is possibly Sanofi’s connected insulin pen solutions. Below, FENIX provides pictures and brief thoughts on the potential Sanofi connected pen platform for disposable and reusable insulin pens.

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 Rule on Definition of “biological product”; ATTD 2020 Key Press Releases (Feb 20)

On the second day of the ATTD 2020 conference, a series of diabetes-related press releases have been observed including Abbott Libre RWE, Tandem to file Control IQ for peds in March 2020, Roche’s new “InsulinStart” program, Companion Medical compatibility with Fiasp, and MannKind Afrezza PK and pulmonary function data. Separate from the conference, FDA announced that it has issued a final rule on the definition of a biological product ahead of the March 23, 2020 insulin reclassification from a drug to a biologic. 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.

Novo Q4 ’19 London Earnings; Sanofi and BD Q4 ’19 Earnings Updates

Novo Nordisk hosted its post-Q4 ’19 earnings event in London. Furthermore, Sanofi and Becton Dickinson held their respective Q4 ’19 earnings calls. Below, FENIX provides highlights and insights from the earnings calls including Sanofi’s plans to divest its interest in efpeglenatide as well as thoughts on how Novo’s QW basal insulin icodec could have broader implications to the hybrid closed-loop 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.

Positive Topline Novo QW Insulin Results; Novo Q4 ’19 Earnings Update

Novo Nordisk hosted its Q4 and FY 2019 earnings call and provided updates to its diabetes business, including a Rybelsus launch update as well as Ph2 topline results for its QW insulin LAI287 (now called insulin “icodec”). 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.

Thoughts on New CVS Program to Eliminate Diabetes Drug OOP Costs

CVS Health recently announced a new program called “RxZERO,” which is said to completely eliminate all out of pocket costs (OOP) for diabetes prescription drugs. According to the press release, RxZERO will provide the benefit to members “without raising costs for the plan sponsor or increasing premiums or deductibles for all plan members.” Below, FENIX provides thoughts on the RxZERO program in the context of the ongoing drug pricing debate in the US.

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.