Category Archives: Topics

Novo Nordisk Expands Research Collaboration for Oral Drug Delivery Technologies; eGenesis and University of Miami Collaboration for Human-Compatible Islet Cells

Two cardiometabolic-related news items have been observed: Novo Nordisk announced it will be expanding its existing research collaboration for oral drug delivery technologies with MIT and Brigham and Women’s Hospital; and eGenesis announced a research collaboration with the University of Miami Leonard M. Miller School of Medicine to evaluate gene-edited pancreatic human-compatible islet cells in T1DM. Below, FENIX provides highlights and insights for the respective new items.

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Know Labs Prepares for FDA Pre-submission Meeting; FDA Accepts Inventiva’s IND for Ph2 Combination (lanifibranor+empa) Trial; Dexcom CGMs Integrated With Happy Bob

Three cardiometabolic-related news items have been observed: Know Labs issued a press release outlining its planned activities ahead of an FDA pre-submission meeting for its non-invasive Bio-RFID technology (press release); Inventiva announced that FDA has accepted Inventiva’s IND for its Ph2 combination lanifibranor+empa trial (LEGEND) in NASH +T2DM; and Harald AI announced that its subscription-based, diabetes management app, Happy Bob, has been integrated with Dexcom CGMs. Below, FENIX provides highlights and insights for the respective new items.

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BD Spinoff Embecta Hosts Virtual Investor Event; Discloses Insulin Patch Pump Program for T2DM

Embecta hosted a virtual investor event (slides; webcast) where management provided an overview of the company in terms of the global diabetes landscape, its position in the market, benefits of the spin-off, and global growth opportunities. Recall, in May 2021, BD announced plans to spin off its diabetes business as an independent, publicly-traded company (previous FENIX insight) and in February 2022, the company’s board of directors approved the planned spinoff (view press release). Of note, during the investor event, Embecta disclosed that the company is developing an insulin patch pump designed to reduce adoption barriers for individuals with T2DM. Below, FENIX provides highlights and insights from the presentation as it relates to the patch pump device.

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Beta Bionics Management Changes Ahead of Insulin-only iLet Bionic Pancreas Launch; Glooko Partners with Johns Hopkins

Two cardiometabolic-related news items have been observed: Beta Bionics recently announced executive leadership and board transitions ahead of launching its insulin-only iLet bionic pancreas; and Glooko announced a collaboration with Johns Hopkins HealthCare Solutions to helps patients with their diabetes management. 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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Lexicon Faces Another Sota Setback; Biocon to Acquire Viatris Biosimilars Business; Viatris Confirms Generic Ozempic Filing

A series of cardiometabolic-related news items have been observed: Lexicon announced it has withdrawn the sotagliflozin HF NDA; Lexicon hosted its Q4 and FY ’21 earnings call (press release); Biocon/Viatris announced Biocon will acquire the Viatris Biosimilars business; Viatris hosted an investor day and disclosed it has filed a generic Ozempic (press release; slides). Below, FENIX provides highlights and insights for the respective new items.

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Lilly Moves Forward with Dicerna ANGPTL3 Asset; Ionis and MannKind Q4 ’21 and FY ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed: Lilly initiated a Ph2 study evaluating LY3561774 (ANGPTL3 from Dicerna) despite the Novo Nordisk acquisition of Dicerna (view CT.gov record); and Ionis (press release; slides) and MannKind (press release) hosted their respective earnings calls. Below, FENIX provides highlights and insights for the respective new items.

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EMPEROR-Preserved Approved by FDA; Wegovy Supply Restored for Existing US Patients; Provention Bio Q4 and FY ’21 Earnings Update; Omada Closes $192M Series E

A series of cardiometabolic-related news items have been observed: FDA approved BI/Lilly’s HFpEF indication (view FDA press release; view BI/Lilly press release); Novo Nordisk’s Wegovy supply for existing US patients has been restored (view Novo Nordisk website); Provention Bio hosted its Q4 and FY ’21 earnings call (view press release); and Omada Health raised $192M in a Series E round (view press release). Below, FENIX provides highlights and insights for the respective new items.

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