Category Archives: Topics

Dexcom Super Bowl DTC; Pfizer Q4 and FY ’20 Earnings Update

Two diabetes-related news items have been observed: Dexcom announced the debut of its first-ever Super Bowl commercial; and Pfizer hosted its Q4 ’20 earnings call, commenting on its oral GLP-1 pipeline developments. Below, FENIX provides highlights and insights for the respective news items, including thoughts on how the Dexcom Super Bowl commercial signals that Dexcom is ready to move on the CGM mass market opportunity.

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CGM: SENS/Ascensia Reinitiate EU Eversense XL Commercial Activities; Nemaura Appoints Jay Warner as Head of US Commercial Operations

Two diabetes-related news items have been observed: Senseonics announced its partner, Ascensia, has reinitiated EU commercial activities for the Eversense XL implantable CGM system; and Nemaura Medical announced the appointment of Jay Warner as Head of US Commercial Operations. Below, FENIX provides highlights and insights for the respective news items, including the curious mention of Livongo in the Nemaura press release.

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Lilly Advances 5 New CV/Met Assets to Ph1; Lilly Q4 and FY ’20 Earnings Update

Lilly hosted its Q4 and FY ’20 earnings call and provided updates across its diabetes portfolio including the disclosure of five new early-stage pipeline assets that have advanced into Ph1 development. Of note, tirzepatide discussion was limited as much of the call focused on the development of donanemab in early symptomatic Alzheimer’s disease. Below, FENIX provides highlights and insights from the call.

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Lilly and Life for a Child Expand Partnership; ViaCyte Appoints Michael Yang as CEO

Two diabetes-related news items have been observed: Lilly and Life for a Child announced an expansion of their partnership to continue addressing inequity in accessing quality diabetes care for children and young adults around the world; and ViaCyte announced the appointment of Michael Yang as the company’s CEO and member of the Board of Directors. Below, FENIX provides highlights and insights for the respective news items.

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Abbott Q4 ’20 Earnings Update and US DTC; Apple and Samsung Watch CGM?; Dario Acquires Upright Technologies

A series of diabetes-related news items have been observed: Abbott hosted its Q4 and FY ’20 earnings call; Abbott recently published an article on its website titled “FreeStyle Libre 2 Puts NBA Legend Ray Allen at Ease;” the Apple Watch Series 7 and the Samsung Galaxy Watch4 are both reportedly going to feature glucose monitoring; and DarioHealth announced its acquisition of Upright Technologies, a digital musculoskeletal company. Below, FENIX provides highlights and insights for the respective news items.

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New Novartis CV Regulatory Comments; Novartis and J&J Q4 ’20 Earnings Updates

Novartis and J&J hosted their Q4 and FY ’20 earnings calls and provided updates to their respective cardiometabolic businesses. Of note, Novartis highlighted the upcoming Q1 ’21 PDUFA date for PARAGON-HF and discussed the inclisiran CRL issued in December 2020. Novartis anticipates responding to FDA’s CRL for inclisiran in Q2 or Q3 ’21. Additionally, J&J comments on its CV/Met portfolio were limited as a majority of the call was focused on the company’s COVID-19 vaccine development. Below, FENIX provides highlights and insights for the respective news items, including thoughts on what the Entresto HFpEF indication may cover.

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Adocia Reports Positive BC Lispro Data with Tonghua Dongbao Insulin; January 25-29 CHMP Agenda

A series of cardiometabolic-related news items have been observed: Adocia announced positive results from a BioChaperone Lispro trial using insulin sourced from Tonghua Dongbao; and the CHMP agenda for this month’s meeting (January 25-29, 2021) has been released, and it includes one notable item: EMPEROR-Reduced is on the CHMP agenda but not believed to be up for an opinion. Below, FENIX provides highlights and insights from the respective news items.

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New Diabetes/COVID-19 Publication in JDST

The Diabetes Technology Society announced the publication of a report titled, “How to Best Protect People With Diabetes From the Impact of SARS-CoV-2: Report of the International COVID-19 and Diabetes Summit” in the Journal of Diabetes Science and Technology. The report is a summary of the Virtual International COVID-19 and Diabetes Summit, which was held on August 26-27, 2020, and included 79 speakers from NIH, CDC, ADA, HCPs, and manufacturers.

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Biocon CY Q4 ’20 (FY Q3 ’21) Earnings Update; Biocon Biologics CEO Resigns

Biocon hosted its CY Q4 ’20 (FY Q3 ’21) earnings call and provided updates on its biosimilar insulin portfolio. Importantly, Biocon disclosed that Christiane Hamacher, the CEO of Biocon Biologics, has resigned “due to professional differences with the chairperson on strategic priorities and vision for the company.” Below, FENIX provides highlights and insights from the call relating to the corporate restructuring and Biocon’s bs-insulin portfolio.

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Oramed Randomizes First Patients in Ph3 Oral Insulin Trial; Dario Hires New Employer Sales Lead

Two diabetes-related news items have been observed: Oramed has begun randomizing patients into its Ph3 ORMD-0801 T2DM study (view press release) and Dario announced the hiring of Chris Chan as the company’s new SVP of employer sales (view press release). Below, FENIX provides highlights and insights from the respective news items.

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