Category Archives: Glucose Monitoring

BI/Lilly’s Jardiance Receives FDA Priority Review; Novo’s Wegovy Receives Positive CHMP Opinion; Merck/Bayer Initiate New Ph3 Verquvo Study; Dario Enters Three New Commercial Agreements; Gmax Administers First in Human Dose of GMA106 in Ph1 Obesity Study; Metacrine and Zealand Q3 ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed from BI/Lilly, Novo Nordisk, Zealand, Merck/Bayer, Dario, Gmax Biopharma, and Metacrine. Below, FENIX provides highlights and insights for the respective news items, including an updated projection of the EMPEROR-Preserved PDUFA date.

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Bayer and Senseonics Q3 ’21 Earnings Updates; Abbott and ADA Launch Community Initiative; Provention Bio Launches #Type1TestedPledge Campaign; Beyond Type 1 Receives $750,000 Grant

A series of cardiometabolic-related news items have been observed: Bayer (press release; slides) and Senseonics (press release) hosted their respective Q3 ’21 earnings calls; Abbott and the American Diabetes Association (ADA) announced the launch of their first joint community initiative in Columbus, Ohio; Provention Bio announced the launch of its #Type1TestedPledge Campaign for Diabetes Awareness Month; and Beyond Type 1 announced it has received a $750,000 Grant from the Helmsley Charitable Trust. Below, FENIX highlights and insights for the respective new items.

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GSK’s Daprodustat Ph3 Data Positive But Not Entirely Clean; BI/Lilly’s Jardiance Demonstrates Consistent Cardio-Renal Benefits in HF; Novo Announces Positive Ph3b STEP 5 Trial Results; CytoDyn Reports Positive Preliminary Data from Ph2 Leronlimab Trial; Roche and Sanofi Mallya Collaboration; Intuity Medical’s Automatic BGM Available in US; Zealand and DEKA Collaboration for Continuous Infusion Pump

A series of cardiometabolic-related news items have been observed from GSK, BI/Lilly, Novo Nordisk, CytoDyn, Roche, Intuity Medical, and Zealand. Below, FENIX provides highlights and insights for the respective news items.

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Lexicon, Tandem, Amarin, Intercept, and Amgen Q3 ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed: Lexicon (press release), Tandem (press release), Amarin (press release; slides), Intercept, (press release; slides), and Amgen (press release; slides), hosted their respective Q3 ’21 earnings calls. Importantly, Lexicon discussed its US sotagliflozin commercial strategy suggesting it is moving forward on its own. Below, FENIX provides highlights and insights from the respective news items.

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Zealand Announces Presentation of Preclinical and Clinical Data on ZP8396 and BI 456906; BING Innovations Launches DigiVibe; Dario Signs Remote Patient Monitoring Services Contracts; National Diabetes Awareness Month Activities

A series of cardiometabolic-related news items have been observed: Zealand announced preclinical data for its amylin analog (ZP8396) and clinical data for its GCG/GLP-1 dual-agonist (BI 456906; out-licensed to Boehringer Ingelheim) were presented at The Obesity Society Annual Meeting; BING Innovations announced the launch of DigiVibe to reduce pain associated with SMBG; Dario announced it has signed two new contracts with regional providers for its Remote Patient Monitoring services for patients living with diabetes and hypertension; and Dexcom (view press release), Insulet (view press release), and DaVita (view press release) announced various activities to recognize National Diabetes Awareness Month and World Diabetes Day. Below, FENIX provides highlights and insights for the respective news items.

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Dexcom Q3 ’21 Earnings Update

Dexcom hosted its Q3 ’21 earnings call (press release; slides) and provided updates to its clinical and commercial activities, including the G7 OUS launch anticipated later in 2021 as well as the impending G7 510(k) submission “in the next few weeks.” Below, FENIX provides highlights and insights from the call.

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Teladoc Q3 ’21 Earnings Update

Teladoc hosted its Q3 ’21 earnings call (press release; slides) and provided updates to its business. Below, FENIX provides highlights and insights from the call, including a summary of comments made about Livongo+Dexcom.

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Apple Watch 8 Reportedly Set to Include BGM; Lifescan Launches OneTouch Solutions; Xeris and Merck Collaboration; Dario Partners with New Employer Group; Tidepool Period Project Receives Financial Support

A series of cardiometabolic-related news items have been observed: New reports suggest the Apple Watch Series 8 may include a blood glucose reader (view article); Lifescan announced the launch of OneTouch Solutions; Xeris announced a collaboration agreement with Merck to leverage Xeris’s injection suspension technology “for the purpose of engineering ultra-high concentration, ready-to-use [mAb] formulations”; Dario announced a new agreement with a US national employer; and Tidepool announced it has received financial support from Amazon Web Services (AWS) for Tidepool Period Project. Below, FENIX provides highlights and insights for the respective news items.

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Viatris’ Semglee Preferred on Express Scripts NPF; DreaMed’s Advisor Pro Launched in Leading Children’s Hospital; MiniMed 780G & Guardian 3 TIR In Pediatrics Comparable to Adults; Abbott and Roche Q3 ’21 Earnings Updates; vTv Therapeutics Hires New President and CEO; Adhera Adds Target Indications for MLR-1023

A series of cardiometabolic-related news items have been observed from Viatris, DreaMed, Medtronic, Abbott, Roche, vTv Therapeutics, and Adhera Therapeutics. Below, FENIX provides highlights and insights for the respective news items.

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Lilly’s Ph3 Tirzepatide SURPASS-4 Results Published in Lancet; FDA Pre-Submission for rt-Glucose Salivary Test; Ultrahuman Hires Chief Business Officer; J&J Q3 ‘21 Earnings Update

A series of cardiometabolic-related news items have been observed: Lilly announced results of its Ph3 SURPASS-4 trial comparing tirzepatide to insulin glargine in patients with T2DM and an increased CV risk were published in The Lancet (view publication); IQ Group Global announced that GBS Inc has filed a pre-submission package with FDA for its salivary glucose test; Ultrahuman announced Bhuvan Srinivasan will join the company as its first chief business officer; and J&J hosted its Q3 ’21 earnings call (press release; slides). Below, FENIX provides highlights and insights for the respective news items.

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