Category Archives: Glucose Monitoring

Sarissa Capital Challenges Amarin’s Management; Nemaura Receives Provisional Purchase Order from TPMENA

A series of cardiometabolic-related news items have been observed: Sarissa Capital Management LP announced plans to initiate the process of holding a special meeting of Amarin shareholders to reorganize the company’s Board; and Nemaura announced it received a provisional purchase order from its Middle East/North Africa licensee, TPMENA, for the non-invasive sugarBEAT CGM system. 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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Roche Diabetes Partners with New Mark Cuban Company

Mark Cuban’s new company, Cost Plus Drugs, announced on Twitter (view tweet here) it has partnered with Roche Diabetes Care USA to provide patients with select Accu-Chek BGM products. Below, FENIX provides highlights and insights about the Cost Plus Drugs and Roche partnership.

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.

Indigo Expands Multi-Metabolite Sensor Development; GlucoTrack to Develop CGM for T1DM; AZ Initiates New Dapa + Zibotentan Ph2 Trial; Sciwind Initiates Patient Dosing in Ph1 Oral GLP-1RA Trial; Ascensia Completes Initial European E3 CGM Launch; October CHMP Agenda

A series of cardiometabolic-related news items have been observed from Indigo, GlucoTrack, AstraZeneca, Sciwind, Ascensia, and EMA. 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.

Abbott Expands Libre 3 Distribution to Pharmacy; Second Ph3 Cagrisema Trial Posted on CT.gov; Galectin NASH Trial to Continue After Second DSMB Meeting

Three cardiometabolic-related news items have been observed: Abbott’s Freestyle Libre US patient website has been updated to announce the expansion of Libre 3 distribution into retail pharmacies; the second trial in Novo Nordisk’s cagrisema pivotal program (REDEFINE) has been observed (REDEFINE 1; view CT.gov record); and Galectin Therapeutics announced positive feedback from its second DSMB meeting for the Ph2b/3 NAVIGATE study (view CT.gov record) evaluating belapectin in patients with liver cirrhosis caused by NASH. 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 Expands ex-US G7 Launch; Novo to Initiate OASIS 4 Ph3 Oral Sema Obesity Trial; Lilly to Initiate two Lp(a) Ph2 Trials; Better Therapeutic Publishes BT-001 Pivotal Trial Results in Diabetes Care

Four cardiometabolic-related news items have been observed: Dexcom announced the launch of Dexcom G7 CGM in the UK, Ireland, Germany, Austria, and Hong Kong and hosted an associated pre-recorded streaming event (view here); a Novo-sponsored Ph3 study (OASIS 4) evaluating QD 25mg oral semaglutide in overweight and obese participants has been observed (view CT.gov record); Lilly initiated two Ph2 studies evaluating QD oral LY3453329 (KRAKEN; view CT.gov record) and injectable LY3819469 (view CT.gov record) in adults with elevated Lp(a); and Better Therapeutics announced the publication of 90-day results from its pivotal trial for BT-001, in Diabetes Care. 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.

Tirzepatide Approved in Japan; Nemaura and EVERSANA Partner for BEATdiabetes; SURMOUNT-MMO Trial Record Posted

Three cardiometabolic-related news items have been observed: Lilly announced tirzepatide is approved in Japan (press release); Nemaura announced a preliminary commercialization agreement with EVERSANA for BEATdiabetes (press release); and Lilly’s Ph3 tirzepatide obesity outcomes trial (SURMOUNT-MMO) has been posted on CT.gov (view CT.gov record). 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.

Lilly’s Tempo Smart Button Receives 510(k) Clearance; EASD 2022 Key Press Releases (Sept 21)

On the third day of EASD 2022, three key press releases were observed from Zealand, Carmot Therapeutics, and Abbott. Separately, Lilly’s Tempo Smart Button received FDA 510(k) clearance on September 16, 2022 (view FDA website), although Lilly has not issued a press release. Below FENIX provides insights and context for the respective announcements.

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 Promotes Jake Leach to COO; Biocon Receives More Form 483 Observations; Seraxis Appoints Paul Strumph as CMO; Intarcia ITCA-650 CRL Chronicle Concludes

A series of cardiometabolic-related updates have been observed: Dexcom announced Jake Leach (view LinkedIn) has been promoted to COO; Biocon announced it received more Form 483 observations; Seraxis announced the appointment of Paul Strumph (view LinkedIn) to CMO; and Intarcia Therapeutics received a letter from FDA (view here) denying a hearing for ITCA-650. Below, FENIX provides context and insight on 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.

Medtronic CY Q2 ‘22 Earnings Updates; Glytec Collaborates with CPS for Glycemic Management Technology

Two cardiometabolic-related news items have been observed: Medtronic (press release; slides) released their CY Q2 ‘22 (FY Q1 ‘23) earnings, including updates to the ongoing FDA warning letter situation; and Glytec announced a partnership with CPS to offer glycemic management technology to HCPs (press release). Below, FENIX provides context and insight on 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 Announces Positive Ph2 Cagrisema Results; Insulet’s Omnipod 5 Receives Expanded FDA Clearance; Digbi Health Enrolled in Novo’s Accelerator Program; New Lyumjev Trial for Inreda’s Bi-hormonal AID System; Amarin Discontinues Vazkepa in Germany

A series of cardiometabolic updates have been observed: Novo announced positive topline results from its Ph2 study of cagrisema in T2DM; Insulet announced Omnipod 5 received expanded FDA clearance in patients down to 2 years of age; Digbi Health has enrolled in Novo’s Global Prevention Accelerator program; an Inreda-sponsored study has been observed evaluating Lyumjev in its bi-hormonal closed loop system (FAST 1; view CT.gov record); and Amarin announced it is discontinuing Vazkepa in Germany. Below, FENIX provides context and insight on 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.