Category Archives: Glucose Monitoring

Novo Announces Positive Ph2 Cagrisema Results; Insulet’s Omnipod 5 Receives Expanded FDA Clearance; Digbi Health Enrolled in Novo’s Accelerator Program; New Lyumjev Trial for Inreda’s Bi-hormonal AID System; Amarin Discontinues Vazkepa in Germany

A series of cardiometabolic updates have been observed: Novo announced positive topline results from its Ph2 study of cagrisema in T2DM; Insulet announced Omnipod 5 received expanded FDA clearance in patients down to 2 years of age; Digbi Health has enrolled in Novo’s Global Prevention Accelerator program; an Inreda-sponsored study has been observed evaluating Lyumjev in its bi-hormonal closed loop system (FAST 1; view CT.gov record); and Amarin announced it is discontinuing Vazkepa in Germany. Below, FENIX provides context and insight on the respective news items. 

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Novo Withdraws PIONEER START Trial; Onduo Partners with Sword Health; Nemaura and Movano Q2 ’22 Earnings Updates

A series of cardiometabolic updates have been observed: Novo’s PIONEER START trial (H2H oral sema vs. empa) has been withdrawn (CT.gov record); Onduo announced a partnership with Sword Health to integrate Sword Health’s musculoskeletal digital solution (press release); and Nemaura (press release) and Movano (press release; webcast) released their Q2 ’22 earnings. Below, FENIX provides highlights and insights from the respective news items.

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Abbott Expands CGM Manufacturing Capacity; Dario and Embecta Q2 ‘22 Earnings Updates

Three cardiometabolic-related news items have been observed: Abbott reportedly plans to invest $450M to expand CGM manufacturing (view article); and Dario (press release) and Embecta (press release; slides) hosted their respective Q2 ‘22 earnings calls. Below, FENIX provides highlights and insights for the respective new items.

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FDA Detects Impurities in Samples of Merck’s Januvia; Senseonics and Ionis Q2 ’22 Earnings Updates

Three cardiometabolic-related news items have been observed: FDA’s website has been updated noting elevated levels of NTTP have been observed in samples of sitagliptin (view here); and Senseonics (press release) and Ionis (press release; slides) hosted their respective Q2 ’22 earnings calls. Below, FENIX provides highlights and insights for the respective new items.

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Insulet, Provention Bio, Bayer, and Regeneron Q2 ‘22 Earnings Updates; Abbott Partners with WeightWatchers

A series of cardiometabolic-related news items have been observed: Insulet (press release), Provention Bio (press release), Bayer (press release; slides), and Regeneron (press release; slides) hosted their respective earnings calls; and Abbott announced a partnership with WeightWatchers for Libre CGM data integration. Below, FENIX provides highlights and insights for the respective new items.

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Lexicon Q2 ’22 Earnings Update; CLEAR Outcomes CVOT Reaches 100% MACE Accumulation; Esperion Q2 ’22 Earnings Update; Dexcom ONE Available with Prescription in UK; Gan & Lee Dose First Patient in Ph2 GZR18 Trial for T2DM; Structure Therapeutics Advances Diabetes & Obesity Clinical Program

A series of cardiometabolic-related news items have been observed: Lexicon (press release; slides) and Esperion (press release; slides) hosted their respective Q2 ’22 earnings calls; Dexcom announced the Dexcom ONE rt-CGM system is now listed on the NHS England, Wales, Scotland, and Northern Ireland drug tariffs; Gan & Lee recently announced the first patient has been dosed in its Ph2 study evaluating the company’s GLP-1RA (GZR18) in T2DM; and Structure Therapeutics announced it has completed dosing in the Ph1 SAD trial for its small molecule oral GLP-1RA (GSBR-1290). Below, FENIX provides context and insight on the respective news items.

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Dexcom G7 Delayed in US; Dexcom, Pfizer, Biocon, Sanofi, and Teladoc Q2 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Dexcom (press release; slides), Pfizer (press release; slides), Biocon (press release), Sanofi (press release; slides), and Teladoc (press release; slides) hosted their respective Q2 ’22 earnings calls. Importantly, Dexcom disclosed the G7 FDA review has been delayed due to updates needed for the app. Below, FENIX provides highlights and insights from the respective earnings calls.

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Abbott Q2 ’22 Earnings Update; Lilly to Initiate Fourth Trial in Ph3 QWINT Program; Ionis’s Ph3 Lp(a) HORIZON CVOT Completes Enrollment

Three cardiometabolic-related news items have been observed: Abbott hosted its Q2 ’22 earnings call (press release; view infographic); a fourth trial from Lilly’s Ph3 QW insulin program has been observed (view CT.gov record); and Ionis announced that the Ph3 Lp(a) HORIZON CVOT evaluating has completed enrollment (view CT.gov record). Below, FENIX provides highlights and insights for the respective new items.

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Abbott Progresses Libre 3 US Launch; New Trial Dasiglucagon Trial for Inreda’s Bi-hormonal AID system; NICE Recommends Amarin’s Vazkepa for Reimbursement in England and Wales

Three cardiometabolic-related news items have been observed: Abbott has recently posted a series of eight new instructional videos on its FreeStyle US YouTube channel (view YouTube Channel) for the Libre 3 CGM; an Inreda-sponsored study has been observed evaluating the feasibility of Zealand’s dasiglucagon in its bi-hormonal closed-loop system (STABLE-1; view CT.gov record); and Amarin announced NICE issued final guidance recommending reimbursement for Vazkepa (icosapent ethyl) in England and Wales. Below, FENIX provides highlights and insights for the respective new items.

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Teplizumab Delayed Even Further; Lexicon Wins with LX9211; Novartis Buys a PRV; Nemaura FY ’21 Earnings Update

A series of cardiometabolic-related news items have been observed: Provention Bio announced FDA extended the teplizumab PDUFA date by 3 months to November 17, 2022; Lexicon announced positive LX9211 results in Diabetic Neuropathic Pain and hosted an associated call with investors (view webcast); Novartis has reportedly purchased a PRV from Mallinckrodt (view SEC filing); and Nemaura announced its fiscal year 2021 financial results, including updates on its non-invasive CGM product launches (press release). Below, FENIX provides highlights and insights for the respective news items.

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