Tag Archives: Diabetes

Updated Perspective on Nemaura’s CGM; Lifescan and Noom Collaboration; Dario Q1 ’20 Earnings Update

Several diabetes-related news items have been observed: Nemaura Medical’s CEO provided an interview regarding the company’s H2H CGM study, saying that the CGM used was Abbott’s Libre, Lifescan announced a partnership with Noom to pilot a digital diabetes and weight loss management program, and DarioHealth hosted its Q1 ’20 earnings call. Below, FENIX provides updated perspective on Nemaura’s CGM in light of the recent CEO interview, thoughts on the Lifescan/Noom collaboration, and highlights from the Dario earnings call.

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

Nemaura Announces Positive Initial Data from H2H CGM Study; Mylan Q1 ’20 Earnings Update

Two diabetes-related news items have been observed: Nemaura Medical announced positive early data from a H2H trial of sugarBEAT vs. an undisclosed incumbent CGM device and Mylan hosted its Q1 ’20 earnings call. Below, FENIX provides highlights of the news items as well as thoughts on where sugarBEAT may fit within the CGM market.

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

Ozempic Now Promoted on Victoza HCP Website

Novo Nordisk has recently updated the Victoza HCP website to include messaging for Ozempic. The first image on the Victoza HCP website landing page now states “Consider prescribing once-weekly Ozempic for your appropriate adult patients” with additional Ozempic messaging peppered throughout the Victoza HCP website. As of this publication, there has not been Ozempic messaging added to the Victoza patient website. Below, FENIX provides a brief overview of the Ozempic messaging on the Victoza HCP site as well as thoughts on Novo phasing out Victoza promotion during the COVID-19 pandemic.

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

High-dose Trulicity Data (AWARD-11) Published in the Journal of the Endocrine Society

Lilly announced results from the AWARD-11 high-dose Trulicity trial have been published in the Journal of the Endocrine Society, although only the abstract was available at the time of this blast. Interestingly, while both the 3.0 and 4.5 mg dulaglutide doses met statistical significance according to the efficacy estimand analysis, only the 4.5mg dose reached statistical significance for the treatment-regimen estimand analysis. The 3.0mg miss on A1C is in-line with FENIX’s previous hypothesis following Lilly’s AWARD-11 topline announcement in June 2019. Below FENIX provides a brief summary of the AWARD-11 data as found in the Lilly press release.

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

Insulet Q1 ’20 Earnings Update

Insulet hosted its Q1 ’20 earnings call and provided updates to its diabetes business including the impact of COVID-19 and timing of the Omnipod Horizon launch. Of note, Insulet has filed the updated Horizon algorithm after the company discovered a software anomaly in early March 2020, leading to the trial being put on hold. Below, FENIX provides highlights and insights from the call.

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

Novo Q1 ’20 Earnings Roadshow; Xeris, Teva, and BD Earnings Updates

Novo Nordisk hosted its post-Q1 ’20 earnings roadshow event. Additionally, Xeris, Teva, and Becton Dickinson held their respective Q1 ’20 earnings calls. Teva did not discuss its generic liraglutide nor did BD discuss the status of its T2DM patch pump. Below, FENIX provides highlights and insights from the respective earnings calls.

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

Livongo, MannKind, and Lannett Q1 ’20 Earnings Updates; Senseonics Receives Positive BCBS Coverage Decisions

Livongo, MannKind, and Lannett each hosted their Q1 ’20 earnings call and provided updates to their respective businesses. Senseonics also announced positive coverage decisions from three BCBS plans. Importantly, Lannett said it believes it can file their bs-glargine with FDA as early as 2022. Below, FENIX provides highlights and insights from the calls.

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

Thoughts on DAPA-HF Approval; Farxiga HCP Website Updated

Yesterday, FDA approved Farxiga as the first SGLT2i for the treatment of HFrEF (NYHA class II-IV) in both T2DM and non-T2DM patients. The approval was based on results from the DAPA-HF study which demonstrated a 26% RRR in hospitalization for heart failure or CV death. Below, FENIX provides thoughts on the new Farxiga HF indication, including read-through to Jardiance and the SGLT2i class, and a brief overview of the updated Farxiga HCP website.

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

Farxiga HF Indication Approved (DAPA-HF)

FDA has approved Farxiga to reduce the risk of CV death and hospitalization for heart failure in T2DM and non-T2DM patients based on results from the DAPA-HF outcomes trial (view FDA press release). The DAPA-HF approval comes just one day after FENIX’s estimated date of May 4, 2020. AstraZeneca has not issued a press release nor is the updated label available at the time of this publication. FENIX will be conducting an analysis of the new Farxiga HF indication once the updated label is available.

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

Dexcom/Ypsomed Partner for CGM Integration; Dexcom G6 Approved In Canada for Hospital Use; Diamyd Topline Results

A series of diabetes-related news has been observed: Ypsomed announced a partnership with Dexcom to integrate CGM data with the YpsoPump and develop a hybrid closed-loop system; Dexcom announced Health Canada has authorized use of the G6 CGM to be used in hospitals during the COVID-19 pandemic; and Diamyd announced positive preliminary results from the first part of the Ph1/2 ReGenerate-1 trial evaluating Remygen in T1DM. Below, FENIX provides highlights and insights from the respective news items.

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