Category Archives: Basal Insulin

Novo Q1 ’22 London Earnings; Lilly Initiates Second Trial in Ph3 QWINT Program; Ionis, Provention Bio, Lexicon, and Lannett Q1 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Novo Nordisk hosted its post-Q1 ’22 earnings event (see previous FENIX insight on Q1 ’22 Novo earnings from April 29); a second trial from Lilly’s Ph3 QW insulin program (BIF; LY3209590) has been observed (view CT.gov record); Lexicon (press release), Ionis (press release; slides), Provention Bio (press release), and Lannett (press release) hosted their respective Q1 ‘22 earnings calls. Below, FENIX provides highlights and insights for the respective new items.

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Novo, Dexcom, AZ, Sanofi, Biocon, and Teladoc Q1 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Novo (press release; slides), Dexcom (press release; slides), AZ (press release; slides), Sanofi (press release; slides), Biocon (press release), and Teladoc (press release; slides) hosted their respective Q1 ’22 earnings calls. Below, FENIX provides highlights and insights from the respective earnings calls.

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Novo Reports First QW Basal Insulin Icodec Ph3 Data

Novo announced topline results from its first QW basal insulin icodec Ph3 program (ONWARDS 2) comparing icodec to degludec in 526 patients with T2DM switching from QD insulin. Data demonstrated a statistically superior 0.93% reduction in A1C with icodec vs. 0.71% reduction with degludec. Below, FENIX provides thoughts into ONWARDS 2 icodec results.

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Viatris Glargine Recalled; Carbon Health Launches Diabetes Management Program

Two cardiometabolic-related news items have been observed: Viatris announced a voluntary recall of one batch of its unbranded insulin glargine U100 10 mL vials due to a potential missing label; and Carbon Health announced the launch of its personalized diabetes management program. Below, FENIX provides highlights and insights for the respective new items.

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Lannett Initiates Bs-glargine Pivotal Trial; Tirzepatide Meta-analysis Shows No Increased MACE Risk in T2DM; Provention Bio’s PRV-101 Vaccine Positive Final Results

A series of cardiometabolic-related news items have been observed: Lannett announced the initiation of its biosimilar insulin glargine pivotal trial; A CV safety meta-analysis for the tirzepatide Ph3 SURPASS program was published in Nature Medicine and showed no increased MACE risk in T2DM (view publication); and Provention Bio announced PRV-101 vaccine positive final results (press release). Below, FENIX provides highlights and insights for the respective new items.

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Supersapiens Energy Band Review Published in Rouleur; Arecor Granted US Patent for Insulin Products; 9am.health and Ascensia Collaboration

A series of cardiometabolic-related news items have been observed: A review of the Supersapiens Energy Band Version Zero has been published in a well-known British cycling magazine (view review here); Arecor announced it has been granted patent US11278624 by the US Patent and Trademark Office protecting novel formulations of insulin products AT247 and AT278; and 9am.health announced Ascensia’s CONTOUR NEXT ONE blood glucose meter and CONTOUR NEXT test strips are now available to its prediabetes and T2DM patients. Below, FENIX provides highlights and insights for the respective new items.

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Lilly Initiates First QW Insulin Ph3 Trial (QWINT-3); New Novartis Ph1b T1DM Immunotherapy (MHS552) Trial

Two cardiometabolic-related news items have been observed: Lilly has initiated the first Ph3 trial (QWINT-3) from its Ph3 QW basal insulin Fc (QWINT) program (view CT.gov record); and a Novartis-sponsored Ph1b multiple ascending dose study evaluating the safety and tolerability of MHS552 in adults with T1DM has been observed (view CT.gov record). Below, FENIX provides highlights and insights for the respective new items.

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Jardiance EMPULSE Trial Published; Senseonics Q4 ’21 Earnings Update; Novo Initiates Icosema COMBINE 2 Ph3 Trial; Merck’s Oral PCSK9i Enters Ph2; BI Partners with Lifebit; Intercept and Amarin Q4 ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed from BI/Lilly, Senseonics, Novo, Merck, BI/Lifebit, Intercept, and Amarin. Below, FENIX provides highlights and insights for the respective new items.

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