Category Archives: Topics

Abbott/Tandem Finalize AID Partnership; What is Tandem’s Role?

Abbott and Tandem Diabetes Care announced the finalization of an agreement for the two companies to develop and commercialize “integrated diabetes solutions.” Recall, the companies first announced their intention to work together in October 2019 (previous FENIX insight). Below, FENIX provides thoughts on the partnership, including potential insight into how Abbott may be leveraging the Tandem partnership to deal with the Libre 2 Vitamin C interference issue.

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Menarini Launches GlucoMen CGM in Europe

Menarini announced its GlucoMen Day CGM is now broadly available in Europe through Menarini’s affiliates and partners (in territories not directly covered by Menarini). Recall, in April 2019, WaveForm (formerly AgaMatrix) partnered with Menarini to market the CGM in ex-US geographies (previous FENIX insight). WaveForm received CE Mark for the CGM in November 2019 (previous FENIX insight). Below, FENIX provides thoughts on the market potential for GlucoMen in the context of its key differentiators (e.g. needle-less insertion sensor insertion).

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Lilly Launches Educational Initiative; Thane Wettig Joins FibroGen; Tandem Acquires Sugarmate; BI Doses First Patient in Ph2 Dual-agonist Trial; IM Therapeutics Doses First Patient with Novel T1DM Therapy

Five diabetes-related news items have been observed: Lilly initiated a hypoglycemia awareness campaign; former Lilly and Intarcia executive, Thane Wettig, joins FibroGen; Tandem announced the acquisition of Sugarmate; and more. Below, FENIX provides highlights and insights on the respective news items.

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Lyumjev (ultra-rapid lispro) Label Analysis and Supply Conversion Thoughts

Last week, FDA approved Lilly’s ultra-rapid lispro as “Lyumjev,” pronounced [LOOM-jehv] as the second ultra rapid-acting injectable insulin behind Novo’s Fiasp. Of note, the generic name for Lyumjev is lispro-aabc. Below, FENIX provides an in-depth Lyumjev label analysis, including a comparison with Novo on RAI supply conversion strategy, and potential insights into Lilly’s connected pen solution.

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DAPA-HF CHMP Opinion This Week?; CHMP Agenda June 22-25

The CHMP agenda for this month (June 22-25) has been released, and it includes one notable item, a potential DAPA-HF CHMP opinion, as well as several other agenda items. Below, FENIX provides diabetes-related highlights and insights from the June 2020 CHMP agenda.

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Autolus Ph1/2 ALLCAR19 Results and EHA 2020 Investor Call Summary

On Friday, June 12, Autolus held an investor call (press release/ presentation), highlighting updated clinical data from the AUTO1 (CD19 CAR-T) Ph1/2 ALLCAR19 study in ≥2L adult ALL. The data was also presented at EHA (Claire Roddie et al, June 2020). Below, FENIX provides thoughts on the significance of this data, and particularly how it compares to competitor CD19 CAR-Ts from Novartis (Kymriah), Gilead (Yescarta), and Cellectis (UCART19).

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Libre 2 AID Compatibility Issue Worse Than Expected

The Libre 2 FDA approval documents have been released, and the answer is now known as to why Libre 2 was not approved to be compatible with automated insulin delivery (AID) systems. Below, FENIX provides thoughts and insight into the issue and Abbott’s potential next steps.

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Thoughts on Jardiance EMPERIAL 6MWT Full Results

Late last week, BI/Lilly announced full results from the EMPERIAL-Reduced and EMPERIAL-Preserved trials, evaluating Jardiance on exercise ability in patients with heart failure. Recall, in December 2019, BI/Lilly disclosed that both EMPERIAL trials failed to show a statistically significant improvement in the 6-minute walk test (previous FENIX insight). Full results of the studies were presented during the ESC HFA Discoveries program. Below, FENIX provides thoughts on the EMPERIAL trial results in the context of Novartis’s Entresto 6MWT study as well as potential readthrough to AstraZeneca’s DETERMINE studies.

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Libre 2 AID Compatibility Hypothesis

Earlier this week, Abbott announced FDA approval of Libre 2, its successor to the highly successful Libre 14 day CGM system (previous FENIX insight). Despite all of the indicated improvements that Libre 2 received, it was clearly worded that Libre 2 is not approved for use with automated insulin delivery (AID) systems. Below, FENIX hypothesizes as to the reason.

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