Category Archives: Glucose Monitoring

CORRECTING AND REPLACING: JPM 2021 Day 1: DXCM, MDT, TDOC, NVS; FDA Accepts EMPEROR-Reduced sNDA Without Priority Review; Adocia to Develop Beta Cell Therapy for T1DM Treatment

On the first day of JPM 2021, FENIX has provided coverage of presentations by major cardiometabolic companies including Dexcom, Medtronic, Teladoc, and Novartis. Additionally, three separate cardiometabolic-related news items have been observed: BI/Lilly announced FDA has accepted the Jardiance sNDA for the reduction of HFrEF in patients with and without T2DM; Dexcom and Teladoc announced the pilot launch of the new “CGM-powered insights” feature for Livongo for Diabetes users; and Adocia filed a patent for cell therapy in patients with T1DM. Below, FENIX provides a topline summary of key takeaways by company followed by more in-depth coverage.

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Lifescan/Sanvita Complete CGM Pilot Study; Lupin’s Generic Synjardy XR Receives Tentative FDA Approval

Two diabetes-related news items have been observed: the CT.gov record for Lifescan/Sanvita Medical’s CGM pilot study has been updated to reflect an October 2020 completion; and Lupin Limited announced it received tentative FDA approval for 5mg/1000mg, 10mg/1000mg, 12.5mg/1000mg, and 25mg/1000mg empagliflozin + metformin XR tablets. Below, FENIX provides highlights and insights for the respective news items.

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Holiday Hangover: FDA Approves First Generic Glucagon; Novo High-dose Sema EU Filing; Novo Extends COVID-19 Relief Program; Eversense Implantable CGM Delayed by FDA; Provention Bio’s Teplizumab Filing Accepted by FDA; Teplizumab July 2, 2021 PDUFA

During the holiday break, a series of diabetes-related news items were observed from Amphastar, Novo Nordisk, Senseonics, and Provention Bio. Below, FENIX provides highlights and insights for the respective news items.

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Nemaura Launches BEATdiabetes Program and proBEAT Non-invasive CGM in the US

Nemaura announced the US launch of its BEATdiabetes program and proBEAT non-invasive CGM. Recall, Nemaura’s non-invasive sugarBEAT CGM was originally filed under the wellness category (and launched in the US as proBEAT) for people with T2DM and prediabetes as part of the BEATdiabetes platform. A PMA has been filed for sugarBEAT and Nemaura anticipates FDA approval and a US launch by YE ’21. Below, FENIX provides brief insight on the BEATdiabetes launch in the context of Nemaura as an acquisition target.

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Lifescan Launches Online Store with Subscription-based Coaching Services; Welldoc Submits 510(k) with FDA to Expand Insulin Dosing Support; Biocon/Viatris (Mylan) Bs-aspart Receives Positive CHMP Opinion; Poxel Announces Ph2a data from PXL770 in NASH

A series of diabetes-related news items have been observed: Lifescan announced the launch of its OneTouch Store which includes subscription offerings for live diabetes coaching services accessible through the OneTouch Reveal app; Welldoc announced the submission of its 510(k) filing with FDA to expand its insulin dosing support to include bolus and premixed insulin titration for users with T2DM; Biocon/Viatris (Mylan) announced the companies received a positive CHMP opinion for their bs-insulin aspart; and Poxel announced additional results from its Ph2a study of PXL770 in NASH. Below, FENIX provides highlights and insights for the respective news items.

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Lifescan Redacts New CGM’s Latest Trial Record

Diabetes device company Lifescan, famous for its OneTouch portfolio of BGM products, partnered in May 2019 with Sanvita Medical to develop and commercialize a CGM system (previous FENIX insight). Below, FENIX describes how Lifescan/Sanvita redacted the details of a CT.gov record for its latest feasibility trial evaluating the Sanvita CGM system.

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Dexcom 2020 Investor Day Highlights

Dexcom hosted its 2020 Investor Day event and provided updates across its business, including its R&D roadmap, T2DM commercial focus, and international expansion. Interestingly, the event was patient and HCP-focused and comprised of three discussions with HCPs who use CGM in various capacities (including non-diabetes-related). Below, FENIX provides highlights from the event as well as insight into Dexcom’s ongoing transition to focus beyond T1DM and intensively managed T2DM patients.

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Libre 2 Appears to Remain in US Soft Launch; When will Broad Launch Commence?

A series of events and observations have been made that suggest the Libre 2 US commercialization remains in a soft launch; however, a broad launch of the Libre 2 system may be in the near term. Below, FENIX provides analysis on the Libre 2 soft launch, potential insight into Abbott’s rationale to simultaneously market Libre 14-day and Libre 2, and thoughts on whether Abbott would minimize Libre 2 promotional efforts if Libre 3 US approval is around the corner.

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Medtronic CY Q3 ’20 (FY Q2 ’21) Earnings Update; Dario Signs New Deal with Fortune 500 Company; Oramed Screens First Patients in the Ph3 ORMD-0801 Trial

A series of diabetes-related news items have been observed: Medtronic hosted its CY Q3 ’20 (FY Q2 ’21) earnings call (press release; slides); Dario signed a deal with a Fortune 500 company (press release); and Oramed announced it has screened the first patients in its Ph3 oral insulin (ORMD-0801) trial. Below, FENIX provides highlights and insights from the respective news items.

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EMPA-REG OUTCOME Post Hoc Analysis; Abbott Sponsors ADA Health Equity Initiative; Nemaura Launches BEAT Platform and Updated Company Website Ahead of US proBEAT Launch

Three diabetes-related news items have been observed: BI and Lilly announced results from a post hoc analysis of the EMPA-REG OUTCOME trial; Abbott and ADA announced Abbott is the first anchor sponsor of the Health Equity Now (HEN) platform with a $5M contribution towards addressing health disparities for PWD; and Nemaura Medical announced the relaunch of its company website and the launch of its BEAT diabetes website. Below, FENIX provides highlights and insights for the respective news items.

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