Tag Archives: Diabetes

ADA Standards of Care Update: REWIND, CGM TIR Targets, and Victoza Peds

Yesterday, ADA announced updates to its Living Standards of Medical Care in Diabetes. The Living Standards of Care revision now incorporates REWIND CV data, Victoza use in pediatric patients, and the international consensus report on CGM time-in-range goals. Below, FENIX provides thoughts and market implications for each of the respective guideline updates.

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Dexcom Q2 ’19 Earnings Update

Dexcom hosted its Q2 ’19 earnings call and provided updates to its R&D and commercial activities including G7 CGM launch preparations. Below, FENIX provides highlights and insights from the earnings call.

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Merck Q2 ’19 Earnings Update

Merck hosted its Q2 ’19 earnings call but did not provide any updates to its diabetes business beyond the Januvia and Steglatro financial performances. Unsurprisingly, the vast majority of the discussion was focused on Merck’s oncology and HIV portfolios. Below, FENIX provides diabetes-related highlights from the call.

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Empa T1DM Filed with FDA; Oral GLP-1RA Advanced to Ph1; Lilly Q2 ’19 Earnings Update

Lilly hosted its Q2 ’19 earnings call and provided updates across its diabetes business. Of note, Lilly’s pipeline now lists empa T1DM as being filed (FDA refused to accept the initial sNDA). Following the 36-week results from Lilly’s AWARD-11 study, Lilly said it plans to file high-dose Trulicity with regulatory authorities “by late 2019.” Furthermore, Lilly’s oral GLP-1RA, called “GLP-1 NPA” (GLP-1 non-peptide agonist), has advanced to Ph1. Below, FENIX provides diabetes-related highlights and insights from the call, including the assumption that the REWIND CHMP agenda listing for July was only for adoption of supplementary information.

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Sanofi Q2 ’19 Earnings Update

Sanofi hosted its Q2 ’19 earnings call and provided updates to its diabetes business unit including the recent Ph1 initiation for its GLP/GIP/GCG triple agonist (SAR441255). Unsurprisingly, Sanofi did not discuss its recent decision to terminate the Lexicon partnership for sotagliflozin. Below, FENIX provides diabetes-related highlights and insights from the call.

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No Update on REWIND CHMP Decision

A CHMP opinion on Lilly’s REWIND CVOT was anticipated on Friday, July 26; however, there has been no press release from Lilly nor is REWIND listed on the July 2019 CHMP meeting highlights. Below, FENIX provides brief thoughts on the REWIND EU regulatory situation.

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Sanofi Terminates Partnership with Lexicon for Sotagliflozin Development

In a press release announcing topline results from three Ph3 sotagliflozin T2DM trials, Sanofi disclosed that it is “terminating the collaboration to develop, manufacture, and commercialize Zynquista in all ongoing global type 1 and type 2 diabetes programs.” Following Sanofi’s press release, Lexicon issued its own statement declaring Sanofi’s “notice invalid and Sanofi to be in breach of contract.” Below, FENIX provides initial thoughts and insights about the partnership termination including readthrough to AZ and BI/Lilly.

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Biocon CY Q2 ’19 (FY Q1 ’20) Earnings Update

Biocon hosted its CY Q2 ’19 (FY Q1 ’20) earnings call and briefly discussed its biosimilar insulin programs including bs-glargine and bs-aspart. Of note, Biocon recently initiated three Ph1 PK/PD studies for its rHI portfolio. Below, FENIX provides highlights and insights from the call.

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