Category Archives: Topics

Abbott Libre 3 Receives CE Mark

Abbott announced it has received CE Mark for the Libre 3 CGM system. Unlike the Libre 1 and 2 CGM systems which require users to scan the sensor to receive their glucose readings, Libre 3 is a true real-time CGM. Additionally, Abbott has updated the Libre form factor with Libre 3 being approximately the size of two stacked US pennies. According to the press release, Abbott is planning for an EU launch “in the coming months” with no update on a potential US timeline. Below, FENIX provides thoughts on the new Libre 3 CGM features as well as potential implications to Dexcom, Medtronic, Senseonics, and other CGM manufacturers.

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New Semaglutide HFpEF Trial (STEP HFpEF); DAPA-MI Posted on CT.gov; Final Day of EASD 2020 (Sept 25)

On the final day of EASD 2020, no new press releases were observed; however, during the Novo Nordisk obesity session, the speaker disclosed plans to conduct a semaglutide HFpEF study. Additionally, AstraZeneca’s DAPA-MI study has been posted on CT.gov. Below, FENIX provides insights and context from the respective news items, including thoughts on why the STEP HFpEF trial appears to fit into the new paradigm of non-outcomes-based label-enabling studies.

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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.

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BMS and bluebird bio Receive Priority Review for Ide-cel; PDUFA Projected Around March 27, 2021

On Tuesday, September 22, BMS and bluebird bio announced (press release, BMS / press release, bluebird bio) that the FDA has granted a Priority Review for ide-cel (BCMA CAR-T) in ≥4L RRMM with a projected PDUFA date around March 27, 2021. Below, Celltelligence provides additional thoughts on Ide-cel’s anticipated approval and the potential impact on BMS’s CVR milestone if the FDA requests additional information.

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New Novo QW Insulin Icodec Data; Novo Updates Rybelsus Website; Dexcom G6 VA Pharmacy Distribution; Ascensia Partners to Accelerate Data Strategy; REWIND Canada Approval; Oramed ORMD-0801 NASH Data; EASD 2020 Key Press Releases (Sept 22)

On Day 2 of EASD, five key press releases and news items were observed from Novo Nordisk, Dexcom, Ascensia, Lilly, and Oramed. Below FENIX provides insights and context from each respective announcement.

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Insulet Expands DASH Availability in Europe; Nemaura In-Licenses Healthimation Diabetes App; Dario Enters Distribution Agreement with HMC; Arecor uRAI to be Presented Tomorrow; Adocia to Host Business Review; EASD 2020 Key Press Releases (Sept 21)

On the first day of EASD, five key press releases were observed from Insulet, Nemaura Medical, DarioHealth, Arecor, and Adocia. Below FENIX provides insights and context from each respective announcement.

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Updated AUTO3 Ph1/2 ALEXANDER Results; ESMO 2020 Investor Call Summary

On Friday, September 18, Autolus held an investor call (press release / presentation), highlighting updated clinical data from the AUTO3 (CD19/22 dual CAR-T) Ph1/2 ALEXANDER study in ≥3L DLBCL. The data was also presented at ESMO (E.Tholouli et al, Sep 2020). Below, Celltelligence provides thoughts on the significance of this data, and particularly how it compares to competitor autologous CD19 CAR-Ts from Novartis (Kymriah), Gilead (Yescarta), and BMS (liso-cel).

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Medtronic Recalls Guardian Connect App After Data Upload Disruptions

FDA’s medical device recalls website has been updated with a new recall alert regarding the Medtronic Guardian Connect CGM app. According to the FDA website, the recall is based on a Medtronic CareLink Personal website software update which resulted in the iOS app not automatically uploading its data to the website. Of note, the Guardian Connect app is compatible with both iOS and Android, though the recall only mentioned iOS issues. Below, FENIX provides thoughts on the Guardian Connect app recall and what it could mean for Medtronic and CGM-competitors Dexcom and Abbott.

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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.

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