Tag Archives: Diabetes

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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Xeris Recieves Positive CHMP Opinion; Roche and Diabeloop Partner for AID Development

Two diabetes-related news items have been observed: Xeris announced it received a positive CHMP opinion for its ready-to-use (RTU) rescue glucagon product, called Ogluo, and Roche announced a partnership with Diabeloop to enhance Roche’s pump hardware platform. Below, FENIX provides highlights and insights for the respective news items.

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Novo Partners with Procyon Technologies for T1DM Stem-Cell Treatment; Bigfoot Expands Commercial Leadership Team; JDRF and Provention Bio Launch T1DM Screening Campaign; New Arecor Trial for Ultra-concentrated RAI; City of Hope Initiates Ph1 T1DM Vaccine Trial

A series of diabetes-related news items have been observed: earlier this week, Procyon Technologies LLC announced it has entered into a partnership with Novo Nordisk for the development of an implantable cell encapsulation device to be combined with Novo’s stem cells for the treatment of T1DM; Bigfoot Biomedical announced new hires within the company to build out its commercial team ahead of the Bigfoot Unity US launch; JDRF and Provention Bio announced the launch of T1Detect, a T1DM screening campaign; a clinical trial has been observed for AT278, Arecor’s ultra-concentrated rapid-acting insulin aspart; and City of Hope announced enrollment has opened for a Ph1 T1DM vaccine trial. 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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Lilly Ph3 Tirzepatide SUPRASS-1 Data Lives up to Ph2b Hype

Lilly announced topline results from the first tirzepatide Ph3 study, SURPASS-1. The study demonstrated up to a -2.1% reduction in A1C and -9.5kg weight loss with 15mg tirzepatide, according to the trial product estimand (e.g. per-protocol analysis). Full results from the SURPASS-1 trial are scheduled to be presented at the ADA 2021 conference (June 25-29). Of note, Lilly has also recently initiated three additional Ph3 studies in the tirzepatide obesity program (SURMOUNT 2, 3, and 4). Below, FENIX provides a SURPASS-1 comparative analysis, including thoughts on tirzepatide in the context of high-dose Ozempic, high-dose Rybelsus, and high-dose Trulicity.

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Thoughts on Ionis Investor Day Event

Yesterday, Ionis hosted its 2020 Investor Day event and provided updates to its pipeline developments, including its PCSK9i that has been licensed to AstraZeneca (ION449/AZD8233). Importantly, Ionis provided details on the discontinuation of its oral formulation of the AZ PCSK9i in favor of a next-gen version. Below, FENIX provides cardiometabolic-related highlights and insights from the event.

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Novo Retracts CONCLUDE (H2H Tresiba vs. Toujeo) Press Release

Novo Nordisk announced the Danish Maritime and Commercial High Court ruled Novo’s September 19, 2019 press release regarding the full results from the CONCLUDE trial (H2H Tresiba vs. Toujeo in T2DM; view original press release here) violated the Danish Marketing Practices Act and the Danish Medicines Act. However, Novo did not disclose which specific portion of the September 2019 press release was in violation. In case you missed it, here is a link to FENIX’s insight on the CONCLUDE result following the presentation at EASD 2019.

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Novo Files Sema 2.4mg Obesity Indication with FDA

Novo Nordisk announced it has filed the NDA for the semaglutide 2.4mg obesity indication. Recall, Novo disclosed in October 2020 that it would be using a PRV voucher, which reduces the review to 6 months. Below, FENIX provides thoughts on the anticipated approval timeline for sema 2.4mg and readthrough to Novo’s AM833 (amylin analog) development.

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