Category Archives: Basal Insulin

Sciwind Biosciences Acquires Worldwide Rights to Sanofi’s GIP Receptor Agonists; Diamyd Pauses Initiation of Ph3 DIAGNODE-3 Trial; AMF Medical’s Sigi Patch Pump Receives Breakthrough Device Designation; FDA Authorizes Sample Size Expansion for Fractyl Health’s Revitalize-1 Pivotal Trial

A series of cardiometabolic-related news items have been observed: Sciwind Biosciences announced it has entered into a WW exclusive licensing agreement to develop and commercialize Sanofi’s GIP receptor agonists; Diamyd Medical announced it has paused the initiation of its Ph3 DIAGNODE-3 trial due to potential contamination in the manufacturing process of the Diamyd diabetes vaccine; AMF Medical announced that its insulin patch pump for closed-loop integration (Sigi) has received Breakthrough Device Designation; and Fractyl Health announced FDA authorized the expansion of its Revitalize-1 pivotal clinical study (formerly REVITA-T2Di) sample size from 288 to 420. Below, FENIX provides highlights and insights for the respective new items.

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Medtronic CY Q3 ’21 (FY Q2 ’22) Earnings Update; HAGAR’s GWave Receives Breakthrough Device Designation; Oramed Randomizes 75% of Patients in Oral Insulin Trial; Beyond Type 1 Launches Web Platform in Arabic

A series of cardiometabolic-related news items have been observed: Medtronic hosted its CY Q3 ’21 (FY Q2 ’22) earnings call (press release; slides); HAGAR announced that its non-invasive CGM (GWave) has received Breakthrough Device Designation; Oramed announced it has enrolled and randomized 75% of the 675 T2DM patients in its Ph3 trial (ORA-D-013-1) evaluating its oral insulin; and Beyond Type 1 announced it has launched its web platform in Arabic. Below, FENIX provides highlights and insights for the respective new items.

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Viatris/Biocon Launch Interchangeable Semglee in US; Lexicon Presents SOLOIST/SCORED Renal Subcuts at AHA; CRISPR/ViaCyte to Initiate Ph1 Trial in T1DM; Innovation Zed Announces InsulCheck DOSE 2022 Launch; Nemaura and Dario Q3 ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed from Viatris/Biocon, Lexicon, CRISPR Therapeutics/ViaCyte, Innovation Zed, Nemaura Medical, and Dario Health. Below, FENIX provides highlights and insights for the respective news items.

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November 8-11 CHMP Agenda; Kerendia+SGLT2i Reduce Risk of Composite CV Outcome; Viatris Q3 ’21 Earnings Update

A series of cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (November 8-11) has been released; Bayer announced positive results from an additional sub-analysis from the Ph3 FIDELITY trial demonstrating Kerendia (finerenone) in conjunction with SGLT2i reduced the risk of the composite CV outcome; and Viatris hosted its Q3 ’21 earnings call (press release; slides). Below, FENIX highlights and insights for the respective new items.

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Viatris’s Semglee Gains Preferred Status on Prime Therapeutics’s National Formularies; Zealand’s First Patient Dosed with ZP8396 in Ph1 Trial for Obesity; Insulet, Lannett, Ionis, Provention Bio, BD, and Regeneron Q3 ‘21 Earnings Updates

A series of cardiometabolic-related news items have been observed from Prime Therapeutics, Zealand, Lannett, Ionis, Provention Bio, Becton Dickinson, Regeneron, and Dario. Below, FENIX provides highlights and insights for the respective news items.

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Novo Nordisk Q3 ’21 Earnings Update

Novo Nordisk hosted its Q3 ’21 earnings call (press release; slides) and provided updates across its commercial and pipeline activities, including the ongoing Wegovy and Rybelsus launches, and updates about various pipeline projects. Below, FENIX provides highlights and insights from the call.

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Novo Raises 2021 Guidance; Novo’s “Bigger Than Me” Anti-Obesity Awareness Campaign; Biocon’s Form 483 Observations Revealed; Novel Human Neo-Islet Technology Published

Four cardiometabolic-related news items have been observed: Novo Nordisk announced it has raised its 2021 guidance ahead of the Q3 ’21 earnings release on November 3; Novo has initiated an unbranded “Bigger Than Me” campaign for anti-obesity awareness featuring Queen Latifah (view article); It has been reported that details from the Form 483 observations made in FDA’s September 2021 pre-approval inspection of Biocon’s Malaysian facility were released to the public (view article); and SymbioCellTech announced pre-clinical data for its Neo-Islets technology have been published in PLOS ONE. Below, FENIX provides highlights and insights for the respective news items.

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Novartis’s Entresto Marketing Under DOJ Investigation?; Inventiva’s Ph2a Lanifibranor + Empa Trial (LEGEND); Merck and Sanofi Q3 ’21 Earnings Updates; Roche and Zur Rose Group Collaboration

A series of cardiometabolic-related news items have been observed: It has been reported that Novartis received a request from DOJ regarding details about the marketing and pricing of Entresto since 2016 (view article); Inventiva announced the design of its Ph2a combination (lanifibranor+empa) trial (LEGEND) in patients with NASH and T2DM; Merck (press release; slides) and Sanofi (press release; slides) hosted their respective Q3 ’21 earnings calls; and Roche and the Zur Rose Group announced their collaboration of healthcare products and solutions. Below, FENIX provides highlights and insights for the respective news items.

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Sinocare and EoFlow Diabetes Tech Collaboration; Provention Announces Positive Interim Results for Ph1 PROVENT Trial; Dario Partners with Virgin Pulse; Teva and Adocia Q3 ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed: Sinocare announced it intends to invest $7.9M in EOFlow to combine Sinocare’s sensors with EOFlow pumps in China; Provention Bio announced positive interim results for its PRV-101 vaccine trial (PROVENT); Dario announced a partnership with Virgin Pulse; Teva (press release; slides) hosted its Q3 ’21 earnings call; and Adocia issued a press release for its Q3 ’21 earnings. Below, FENIX provides highlights and insights for the respective news items.

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