Category Archives: Other

DreaMed Partners with Four Additional US Health Clinics

DreaMed Diabetes announced it has partnered with four US clinics to integrate DreaMed’s Advisor Pro software into the clinics’ protocols. For context, the Advisor Pro software uses cloud-based technology and AI to perform data analyses from CGM, insulin pumps, SMBG, and event data to suggest insulin treatment recommendations. Below, FENIX provides thoughts on the partnerships in the context of COVID-19 and the acceleration toward digital health management.

This content is for Read Less members only.
Already a member? Log in here

Dexcom Publishes G6 UK Cost-Effectiveness Data and Launches G6 in Turkey; Lifescan Launches OneTouch Amazon Storefront; Daewoong Pharma Announces Ph2 Results for Enavogliflozin; Zucara Therapeutics Doses First Patient in Preventative Hypo Study

A series of diabetes-related news items have been observed: Dexcom published results from a study evaluating the cost-effectiveness of its G6 CGM in the UK and announced the launch of G6 in Turkey; Lifescan announced the launch of its OneTouch Amazon storefront; Daewoong Pharmaceutical announced the results of a Ph2 trial evaluating enavogliflozin; and Zucara Therapeutics announced the first patient has been dosed in a Ph1 trial of ZT-01 for insulin-induced hypoglycemia. Below, FENIX provides highlights and insights for the respective news items.  

This content is for Read Less members only.
Already a member? Log in here

FDA Launches Digital Health Center of Excellence; Novo Initiates New Ozempic and Rybelsus Trials; vTv Presents TTP399 Data; EASD 2020 Key Press Releases (Sept 23)

On Day 3 of EASD 2020, two key press releases were observed from FDA and vTv Therapeutics. Additionally, two new semaglutide (Rybelsus and Ozempic) clinical trials were observed from Novo Nordisk. Below, FENIX provides insights and context from each respective announcement.

This content is for Read Less members only.
Already a member? Log in here

Diamyd to Move Forward with Ph3 Trial in HLA-Present T1DM Subpopulation; Additional Results from DIAGNODE-2

Yesterday, Diamyd Medical hosted a webcast to present additional details and context from the DIAGNODE-2 trial evaluating the effectiveness of Diamyd (treatment) in preserving endogenous insulin production. Recall, topline results for DIAGNODE-2 were announced earlier this week. Of note, DIAGNODE-2 showed no significant effect in HLA DR3-DQ2-absent T1DM patients as HLA-present patients were the only ones to respond to the treatment. Below, FENIX provides an overview of the results, thoughts on the Ph3 program, and insight into Diamyd’s potential to move forward without a partner.

This content is for Read Less members only.
Already a member? Log in here

Dexcom Announces New CGM Registry and Global Business Service Site in Lithuania; Dario Appoints Former LifeScan Exec to Scientific Advisory Board

Yesterday, a series of diabetes-related news items were observed: Dexcom announced its first registry committed to tracking in-hospital real-time CGM use outcomes; Dexcom announced plans to build a global business service center in Lithuania; and DarioHealth appointed Eric Milledge as chairman of its Scientific Advisory Board. Below, FENIX provides highlights and insights on the respective news items.

This content is for Read Less members only.
Already a member? Log in here

Japanese NDA Submitted for Imeglimin; Poxel H1 ’20 Earnings Update

Yesterday, Poxel hosted its H1 ’20 earnings call and provided updates to its Japanese and US Imeglimin development. Of note, Poxel has submitted the Japanese NDA for Imeglimin and its US partner, Metavant, is actively preparing to initiate a Ph3 program in the US. Below, FENIX provides an overview of the Poxel earnings call and thoughts on Imeglimin development, including its market potential.

This content is for Read Less members only.
Already a member? Log in here

Apple Cites T1DM Omnipod Patient Story at Tuesday Event; Jardiance Post-MI Trial (EMPACT-MI) Receives FDA FTD; Adocia Topline Results from M1Pram Ph1b Trial Extension; Welldoc/UMD Employs AI to Identify Digital Health Habits; Oramed’s Positive Diabetes Market Survey Results; Diamyd Receives $13.9M Towards Companion Medical Shares

A series of diabetes-related news items have been observed: Apple featured a T1DM patient story during the Apple Watch portion of its event; BI/Lilly announced Jardiance has received Fast Track designation for its EMPACT-MI study; Adocia announced positive topline results from its Ph1b M1Pram extension study in PWT1D; Welldoc and the University of Maryland’s Center for Health Information and Decision System (CHIDS) announced findings from a user engagement analysis; Oramed announced results from a diabetes market survey; and Diamyd received $13.9M from its divestment in Companion Medical. Below, FENIX provides highlights and insights from the respective news items.

This content is for Read Less members only.
Already a member? Log in here

Diamyd’s Ph2b DIAGNODE-2 Trial Topline Results; New MicroTech Medical BGM 510(k) Clearance; Voluntis Announces €2M in Funding

A series of diabetes-related news items have been observed: Diamyd announced topline results from its Ph2b DIAGNODE-2 trial, and hosted a brief webcast to discuss the results; MicroTech received 510(k) clearance for its first BGM; and Voluntis secured €2M in financing. Below, FENIX provides highlights and insights related to the respective news items.

This content is for Read Less members only.
Already a member? Log in here

Thoughts on Newly Permanent Lilly Insulin+Baqsimi Copay Cards; New Novo+ACC ASCVD Registry; ProSciento Receives VC Investment

A series of diabetes-related news items have been observed: Lilly permanently committed to the Insulin Value Program $35 copay card besides other savings options for Humulin R U500 and Baqsimi; Novo Nordisk and ACC are launching a new ASCVD T2DM registry; and ProSciento closed a venture capital funding round. Below, FENIX provides an overview of the respective news items as well as thoughts on the economic benefit of the $35 insulin copay card compared to Semglee in addition to how the ACC partnership is beneficial to Novo.

This content is for Read Less members only.
Already a member? Log in here