Category Archives: Topics

Dexcom Non-intensive G6 CGM Updated Approval; Dexcom G5 Receiver Recall; FDA Concludes MET NDMA Impurity Investigation

A series of diabetes-related news has been observed including a new 510(k) clearance for Dexcom’s G6 iCGM in non-intensive diabetes management, Dexcom G5 Mobile Class 2 Device recall, and FDA finalized its investigation into potential metformin impurities. 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.

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Rybelsus and URLi Receive Positive CHMP Opinions

Two important positive CHMP opinions were received this week for Novo Nordisk’s Rybelsus and Lilly’s ultra-rapid lispro product (to be branded as Liumjev). Below, FENIX provides thoughts on the positive CHMP opinions including insight into the ongoing US FDA review of Lilly’s URLi.

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.

Lilly and Roche Q4 ’19 Earnings Updates

Lilly and Roche hosted their respective Q4 and FY 2019 earnings calls and provided updates to their respective diabetes businesses. Of note, Lilly disclosed additional information regarding the impending initiation of the tirzepatide T2DM CVOT, and Roche indicated it plans to pursue smartphone pump control. Below, FENIX provides highlights and insights from the calls including thoughts on how Lilly’s tirzepatide CVOT trial design compares to the 2008 FDA Guidance.

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 to Donate Insulin Pens; Fractyl Launches Revita DMR in the UK

Two diabetes-related news items have been observed including an announcement from Lilly that the company is donating 200k insulin pens over 3 years and Fractyl is launching its Revita DMR device in the UK. 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.

Trijardy XR (empa/lina/met XR FDC) Approved; Trijardy Label and Market Analysis

Late yesterday, Boehringer Ingelheim and Lilly announced FDA approval for their empagliflozin+linagliptin+metformin XR triple FDC, branded as “Trijardy XR.” Below, FENIX has conducted a Trijardy XR label analysis which includes a comparison to AstraZeneca’s Qternmet XR (dapa+saxa+met XR) as well as thoughts on the potential impact of the triple FDCs on the OAD market segment.

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.

Oral Semaglutide and URLi CHMP Opinions Anticipated; Forxiga Lower-limb Warning?; Xeris Gvoke Filed (CHMP Agenda January 27-30)

The CHMP agenda for this month’s meeting (January 27-30) has been released, and it includes four notable items (oral semaglutide opinion, URLi opinion, potential Forxiga lower limb amputation warning, and Xeris’s Gvoke initial filing) as well as some other items. Below, FENIX provides diabetes-related highlights and insights from the January 2020 CHMP agenda.

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.

i-SENS Receives FDA Clearance for Another BT BGM

Approximately 1 week after i-SENS received 510(k) clearance for the Caresens S Fit BT BGM, FDA has cleared another i-SENS Bluetooth BGM called “Caresens S Clear BT.” Below, FENIX provides brief thoughts on the new i-SENS BGM.

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/Mylan Bs-Glargine PDUFA in June 2020; Biocon CY Q4 ’19 (FY Q3 ’20) Earnings Update

Biocon hosted its CY Q4 ’19 (FY Q3 ’20) earnings call and provided updates to the ongoing bs-glargine US review including a more specific FDA approval and launch timeline. Additionally, Biocon discussed how recent legislation has aided the bs-glargine review given the impending March 23, 2020 insulin reclassification. Below, FENIX provides insight and context on the Biocon/Mylan 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.

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 G&L Bs-Glargine Ph1 Trial to Support Approval; J&J and Abbott Q4 ’19 Earnings Updates; New Medtronic AHCL Study; Biocon Generic Dapa Tentatively Approved by FDA

A series of diabetes-related news items have been observed including Gan & Lee completed a Ph1 biosimilarity study for its glargine, earnings calls from Johnson & Johnson and Abbott, Medtronic initiated a new advanced hybrid closed-loop study, and Biocon received tentative approval for generic dapagliflozin. Below, FENIX provides diabetes-related highlights and insights from the calls including thoughts on how the G&L study appears to be in-line with FDA’s thinking on biosimilar insulins.

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.