Category Archives: Bolus Insulin

New Fiasp/Medtronic 670G Study on CT.gov

A CT.gov record for a study evaluating Novo’s Fiasp (faster-acting insulin aspart) in a Medtronic 670G pump has been observed. This Ph4 study is sponsored by Bruce Buckingham’s lab at Stanford, and Medtronic is listed as a collaborator (Novo is not believed to be part of the study). Recall, the Fiasp label does not include designation for use in insulin pumps. Below, FENIX provides insight into the use of ultra-rapid-acting insulin in pumps as well as why a future commercial partnership between Novo and Medtronic could make sense.

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FENIX Analysis: Post-AACE 2018 Drug Promotional Material

In advance of ADA 2018 beginning June 21, FENIX has conducted a comprehensive analysis of new and recent promotional materials obtained at AACE 2018. Notably, this was the first major conference opportunity for Novo to promote both Ozempic and the Tresiba DEVOTE label update.

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Novo Nordisk Q1 ’18 Earnings Update

Novo hosted its Q1 ’18 earnings call (press release) and provided updates on its marketed and pipeline diabetes products. Of note, Novo discussed the relaunch of Tresiba based on the recent DEVOTE label update. Furthermore, Novo disclosed plans to initiate Ph2 for its QW basal insulin (LAI287) by YE ’18. Below are highlights from the call.

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New Novo CMO?

Novo Nordisk has announced its participation in the Hypo-RESOLVE research project. FENIX has made a curious observation based on the press release, which references Stephen Gough as Novo’s “Global Chief Medical Officer in Denmark.” This position was believed to be held by Alan Moses.

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Adocia Partners for BioChaperone Lispro and Combo in China

Adocia has announced a partnership with Tonghua Dongbao Pharmaceuticals for the development and commercialization of BioChaperone Combo (lispro+glargine) and BioChaperone Lispro. The partnership agreement is said to cover China and other designated countries.

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Sanofi’s Head of Global R&D Retiring

Sanofi announced that Elias Zerhouni, the company’s Head of Global R&D, is retiring and will be succeeded by John Reed, the former Global Head of Roche Pharma Research & Early Development.

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Lilly Q1 ’18 Earnings Update

Lilly hosted its Q1 ’18 earnings call (press release) and provided updates on its diabetes business unit. Of note, Lilly affirmed REWIND (Trulicity CVOT) topline readout is anticipated in early Q4 ’18 with full results at ADA 2019. Below are highlights from the call.

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Mylan IR Day Highlights; Biosimilar Victoza and Toujeo in Development

Mylan hosted its Investor Day and provided updates on biosimilar Lantus and Novolog, as well as disclosing for the first time its intentions to develop biosimilar versions of Toujeo, Victoza, and Saxenda. Below, FENIX provides analysis and market implications for each of the biosimilar programs.

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New Lilly uRAI trials including H2H vs. Fiasp

Two new clinical trials for Lilly’s ultra-rapid-acting insulin lispro (LY900014; also called ultra-rapid lispro or “URLi” pronounced “early” [ur-lee] by Lilly at ATTD 2018), have been observed on CT.gov including a Ph1 H2H PK trial vs. Novo’s Fiasp and a Ph3 study in pumps called PRONTO-Pump.

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JPM Day 2: Sanofi, Lilly, Lexicon, Dexcom and more

During Day 2 of JPM, presentations ranged across both diabetes drug (Sanofi, Lilly, Lexicon, and Mylan) and device manufacturers (Dexcom, Insulet, and Roche), although Mylan and Roche did not discuss their diabetes portfolios. Below, find key takeaways from JPM followed by more in-depth coverage.

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