Category Archives: Glucose Monitoring

ICER Report Questions Tirzepatide’s Effectiveness Compared to Ozempic and Jardiance; Signos and Dexcom to Launch CGM+AI-Enhanced App Trial; Teladoc Launches Chronic Care Complete Program; Movano Completes Second Glucose Pilot Study; Better Therapeutic Enrolls First Patient in BT-001 RWE Study

A series of cardiometabolic-related news items have been observed: The Institute for Clinical and Economic Review (ICER) released its report on Lilly’s tirzepatide (view article); Signos announced intentions to conduct a health outcomes study (in partnership with Dexcom) investigating CGM+AI-enhanced app use in people without diabetes; Teladoc announced it has launched its Chronic Care Complete program; Movano announced the completion of its second IRB-approved glucose pilot study evaluating its wrist-worn wearable biosensor prototype; and Better Therapeutics announced the first patient has been enrolled in an RWE study evaluating BT-001 for the treatment of T2DM. Below, FENIX provides highlights and insights for the respective new 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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Nemaura CY Q4 ‘21 and FY ’21 (FY Q3 ‘22) Earnings Update

Nemaura Medical published its CY Q4 ’21 (FY Q3 ’22) business update (press release), though the company did not host an associated webcast with investors. Of note, the company only provided brief commentary on the launch of MiBoKo (view website) for employer groups and insurers/payers, the MySugarWatch DuoPack Limited deal, and the appointment of Dr. Arash Ghadar (view LinkedIn) as COO. Below are highlights from the press release.

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.

Will AZ Fund an Additional Roxa Trial?; Senseonics Eversense E3 CGM Receives FDA Approval

Two cardiometabolic-related news items have been observed: AZ’s Executive VP and head of biopharmaceuticals R&D conducted an interview and commented on the likelihood of performing another roxadustat trial to address the FDA CRL (view article); and Senseonics announced its Eversense E3 CGM (180-day sensor) has received FDA approval. Below, FENIX provides highlights and insights for the respective new 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 ‘21 and FY ‘21 Earnings Update

Dexcom hosted its Q4 ’21 earnings call (press release; slides) and provided updates to its clinical and commercial activities, including the anticipated G7 OUS and US launches throughout 2022. 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.

Diamyd to Initiate Ph3 DIAGNODE-3 Trial in Europe; First Patient Dosed with CRISPR and ViaCyte’s VCTX210 in Ph1 Trial; Know Labs Bio-RFID Device Receives IRB Approval

A series of cardiometabolic-related news items have been observed: Diamyd Medical announced it will proceed to initiate its Ph3 T1DM vaccine trial (DIAGNODE-3) in Europe; CRISPR and ViaCyte announced they have dosed the first patient in their Ph1 VCTX210 trial; and Know Labs recently announced that it received IRB approval for a new trial of its non-invasive glucose monitor. Below, FENIX provides highlights and insights for the respective new 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.

Insulet Omnipod 5 Receives FDA Clearance; BI/Lilly’s Jardiance HFpEF Indication Receives Positive CHMP Opinion; Provention Hosts Teplizumab BLA Resubmission Call with Investors; Lilly to Invest $1.5B in Two New Manufacturing Sites

A series of cardiometabolic-related news items have been observed: Insulet announced FDA has cleared its Omnipod 5 for T1DM patients ≥ 6 years of age; BI/Lilly announced Jardiance (empagliflozin) has received a positive CHMP opinion for extension of indication to add the treatment of patients with HFpEF; Provention hosted a call with investors to provide additional details on the teplizumab BLA resubmission as well as teplizumab LCM initiatives (listen here); and Lilly announced plans to invest over $1.5B in two new manufacturing sites in Concord, North Carolina, and Limerick, Ireland. Below, FENIX provides highlights and insights for the respective new 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.

Libre 3 Filed as iCGM in US; Abbott Q4 ’21 Earnings Update; FDA Warns Lilly for Misleading Trulicity Instagram Promo

Two cardiometabolic-related news items have been observed: Abbott hosted its Q4 ’21 earnings call (press release; view infographic) where it disclosed it filed the Libre 3 CGM with FDA in 2021; and FDA’s Office of Prescription Drug Promotion (OPDP) has issued a letter to Lilly regarding misleading Trulicity social media post (view OPDP letter here; view Trulicity Promo Materials here). Below, FENIX provides highlights and insights for the respective new 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.

J&J Q4 ’21 Earnings Update; Glytec Partners with Nebraska Medicine; Daewoong Pharma Announces Positive Ph3 Enavogliflozin Results in T2DM

Three cardiometabolic-related news items have been observed: J&J hosted its Q4 ’21 earnings call (press release; slides); Glytec announced a strategic partnership with Nebraska Medicine to implement Glytec’s eGlycemic Management System (eGMS); and Daewoong Pharmaceutical announced positive topline results from its Ph3 enavogliflozin program. Below, FENIX provides highlights and insights for the respective new 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.

JPM 2022 Day 4: Lexicon and Esperion; Imcyse Reports Positive Data from Interim Analysis of Ph2 IMPACT Trial; vTv Therapeutics Provides Update on TTP399 Development; Nemaura Launches Miboko to Employers and Insurers

On the final day of JPM 2022, FENIX has provided coverage of presentations by major CVRM companies including Lexicon and Esperion. Additionally, three separate cardiometabolic-related news items have been observed: Imcyse reported positive biomarker data from an interim analysis of the Ph2 IMPACT trial (view press release); vTv Therapeutics has published a new corporate presentation in which the company disclosed plans to initiate the TTP399 Ph3 program in 2022 (view press release); and Nemaura has launched its Miboko wellness program for employer and payer reimbursement (view press release). Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage.

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.

JPM 2022 Day 2: LLY, ABT, AMRN, SNY, AMGN, RHHBY, and TEVA

On the second day of JPM 2022, FENIX has provided coverage of presentations by major CVRM companies including Lilly, Abbott, Amarin, Sanofi, Amgen, Roche, and Teva. Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage

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.