Tag Archives: Medtronic

Provention Bio Refiles Teplizumab BLA; Medtronic and Tandem Q4 ’21 and FY ’21 Earnings Updates; Lilly Invests $700M in New Lilly Institute for Genetic Medicine; RosVivo Therapeutics and Lilly Sign MTA for RSVI-301; February 21-24 CHMP Agenda

A series of cardiometabolic-related news items have recently been observed from Provention Bio, Medtronic, Tandem, Lilly, RosVivo Therapeutics, and the CHMP. 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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JPM 2022 Day 1: DXCM, NVS, BAYRY, MDT, TDOC, VRTX; Sanofi Partners with BrightInsight; Viking Initiates GLP-1/GIP Dual Agonist Ph1 Trial

On the first day of JPM 2022, FENIX has provided coverage of presentations by major CVRM companies including Dexcom, Novartis, Bayer, Medtronic, Teladoc, Vertex, Pfizer, Merck, and JNJ. Additionally, two separate cardiometabolic-related news items have been observed: Sanofi announced a partnership with BrightInsight for a digital companion app (potentially for diabetes); and Viking Therapeutics announced the initiation of a Ph1 trial evaluating its novel GLP-1+GIP dual agonist (VK2735). 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.

Holiday Hangover: Novo Completes Dicerna Acquisition; FDA Approves Novartis’s Leqvio; Lexicon Submits NDA for Sotagliflozin; CMS Medicare Coverage Expansion Includes Non-adjunctive CGMs; Viatris Beats Sanofi’s Insulin-Pen Patent Invalidation Appeal; Beta Bionics iLet Bionic Pancreas Pivotal Trials Update

During the holiday break, a series of cardiometabolic-related news items were observed from Novo Nordisk, Novartis, Lexicon, Medtronic, Viatris, and Beta Bionics. 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.

Medtronic Diabetes Receives FDA Warning; Bigfoot Hires New Senior Leaders; Omada’s mHealth Programs Gain Preferred Status on Evernorth Digital Health Formulary

Three cardiometabolic-related news items have been observed: Medtronic announced it has received a warning letter from FDA on December 9, 2021 for its Diabetes Business headquarters in Northridge, CA; Bigfoot announced the appointment of three new senior leaders; and Omada Health announced that its cardiometabolic digital chronic care programs will be included on the Evernorth Digital Health Formulary. 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.

Medtronic CY Q3 ’21 (FY Q2 ’22) Earnings Update; HAGAR’s GWave Receives Breakthrough Device Designation; Oramed Randomizes 75% of Patients in Oral Insulin Trial; Beyond Type 1 Launches Web Platform in Arabic

A series of cardiometabolic-related news items have been observed: Medtronic hosted its CY Q3 ’21 (FY Q2 ’22) earnings call (press release; slides); HAGAR announced that its non-invasive CGM (GWave) has received Breakthrough Device Designation; Oramed announced it has enrolled and randomized 75% of the 675 T2DM patients in its Ph3 trial (ORA-D-013-1) evaluating its oral insulin; and Beyond Type 1 announced it has launched its web platform in Arabic. 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.

Viatris’ Semglee Preferred on Express Scripts NPF; DreaMed’s Advisor Pro Launched in Leading Children’s Hospital; MiniMed 780G & Guardian 3 TIR In Pediatrics Comparable to Adults; Abbott and Roche Q3 ’21 Earnings Updates; vTv Therapeutics Hires New President and CEO; Adhera Adds Target Indications for MLR-1023

A series of cardiometabolic-related news items have been observed from Viatris, DreaMed, Medtronic, Abbott, Roche, vTv Therapeutics, and Adhera Therapeutics. 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.

Medtronic to Acquire Triple Jump?; Esperion to Reduce Workforce by 40%; Diamyd’s Ph3 T1DM Vaccine Trial Initiated; Vertex Announces Positive Results From Ph1/2 VX-880 Trial

A series of cardiometabolic-related news items have been observed: It has been reported that Medtronic is in advanced discussions to acquire a patch pump company (view article); Esperion announced plans to align operational and expense structure, including a workforce reduction of 40%; Diamyd announced the initiation of its Ph3 T1DM Vaccine trial (DIAGNODE-3) in Europe; and Vertex announced positive results from the first patient in Ph1/2 VX-880 trial for patients with T1DM. 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.

Diamyd’s Ph3 T1DM Vaccine Placed on Partial Clinical Hold; Osama Hamdy Joins Nemaura Scientific Board; Medtronic Licenses Implantable Pump; Diabeloop joins the AACE Corporate Advisory Program and Appoints US Scientific Advisors

A series of cardiometabolic-related news items have been observed: Diamyd’s Ph3 has been placed on partial clinical hold (press release); Nemaura announced Osama Hamdy joined the company’s advisory board (press release); Medtronic licenses implantable insulin pump from the Alfred E. Mann Foundation (press release); Diabeloop joins the AACE Corporate Advisory Program and Appoints US Scientific Advisors (press release). 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.

Gvoke Kit Receives FDA Approval; Medtronic Q2 ’21 Earnings Update

Two diabetes news items have been observed: Xeris announced FDA approved the sNDA for Gvoke Kit (1mg/0.2 mL single-dose vial syringe kit); and Medtronic hosted its CY Q2 ’21 (FY Q1 ’22) earnings call. Below, FENIX provides highlights and insights from the Medtronic call as well as thoughts on how Xeris’s decision to develop the Gvoke Kit was likely influenced by the channel mix.

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.

Ascensia Launches Patient Assistance Program for Eversense; Dario Digital Health Contract; Xeris EU Distribution Agreement for Ogluo; Medtronic Extended Wear Infusion Set 510(k) Clearance; Nimium Partnership for G3PP Activator Development; TempraMed Launches Insulin Cooler Cap

Six cardiometabolic-related news items have been observed from Ascensia, Dario, Xeris, Medtronic, Nimium Therapeutics, and TempraMed. Below, FENIX provides context and analysis for the 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.