Category Archives: Glucose Monitoring

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.

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Insulet Partners with Dexcom and Abbott; ATTD 2020 Key Press Releases (Feb 19)

With the start of the ATTD 2020 conference, a series of diabetes technology-related press releases have been observed including partnerships between Insulet/Dexcom, Insulet/Abbott, Dexcom/Dreamed, and Biocorp/iSage Rx. Additionally, Dario Health presented new data at ATTD 2020 for its connected BGM platform, and Diabeloop initiated a trial to support 510(k) clearance of its automated insulin delivery algorithm. 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.

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Purchase Blast$599.00

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

Medtronic CY Q4 ’19 (FY Q3 ’20); Cigna Reimburses Eversense Implantable CGM; Diasome HDV-Lispro Ph2 Topline Data

Yesterday, a series of diabetes-related news were observed including Medtronic’s CY Q4 ’19 (FY Q3 ’20) earnings call, Senseonics’s positive coverage decision from Cigna for the Eversense implantable CGM, and Diasome’s topline data from its Ph2 OPTI-1 study. 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.

Dexcom Q4 ’19 Earnings Update

Dexcom hosted its Q4 ’19 and FY ’19 earnings call and provided updates to its CGM business. Of note, Dexcom has continued to show significant revenue growth, reaching total topline sales of nearly $1.5B in 2019 (+43% YOY). Below, FENIX provides highlights and insights from the earnings call including a Dexcom comment on Lilly’s smartpen 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.

Senseonics Integrates with Companion Medical; Nemaura Medical CY Q4 ’19 Earnings Update

Senseonics announced a new partnership with Companion Medical to integrate Eversense implantable CGM data into the Companion Medical InPen platform. Additionally, Nemaura Medical issued a press release for its FY Q3 ’19 (CY Q4 ’19) earnings. Below, FENIX provides thoughts on the partnership including why it makes sense for both Senseonics and Companion Medical.

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.

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.

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.

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.

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.

New i-SENS BT BGM 510(k) Clearance; Integrity Non-invasive Glucose Meter CE Mark; Livongo Available to Horizon BCBS NJ; Jay Skyler Joins Oramed Advisory Board

A series of diabetes-related news has been observed including the 510(k) clearance for a new i-SENS BGM (believed to have Bluetooth connectivity), Integrity Applications received CE Mark for its non-invasive glucose meter, Livongo is now available to Horizon BCBS NJ, and Oramed appointed Jay Skyler to its scientific advisory board. Below, FENIX provides highlights and insights related to 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.