Category Archives: Glucose Monitoring

Nemaura Includes Insulin in EU DuoPack License Agreement; Sigilon Q4 ‘22 Earnings

Two CVRM-related news items have been observed: Neumara announced the inclusion of insulin on the list of eligible drugs for its EU DuoPack License Agreement; and Sigilon issued their Q4 ‘22 earnings and disclosed plans to advance its SIG-002 program into the IND-enabling stage (press release). Below, FENIX provides highlights and insights from the news items.

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CLEAR Outcomes Full Results; Abbott Libre 2 and 3 AID Clearance; New Lexicon HF Awareness Campaign; Merck to Advance Oral PCSK9i to Ph3; Amarin Announces Non-Sarissa Board Departures; BI/Lilly COORDINATE-Diabetes Results

A series of cardiometabolic-related news items have been observed from Esperion, Abbott, Lexicon, Merck, and BI/Lilly. Below, FENIX provides highlights and insights into the respective news items.

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CMS Expands CGM Coverage; New Novo R&D Presence in Boston; Bigfoot Unity Android App Approval; Cytokinetic Receives Omecamtiv CRL; Galectin Finalizes Ph2b/3 NAVIGATE Randomization; Imcyse Completes Trial Enrollment; and Zealand, Intercept, and Amarin Q4 ’22 Earnings

A series of cardiometabolic-related news items has been observed from CMS, Novo Nordisk, Bigfoot, Zealand, Intercept, Cytokinetics, Amarin, Galectin, and Imcyse. Below, FENIX provides highlights and insights into the respective news items.

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Esperion Launches Website Featuring CLEAR Outcomes; Abbott Receives 510(k) Approval for APIs; Novartis Initiates Ph3 Inclisiran Primary Prevention Trial; Nemaura and Viatris Q4 ’22 Earnings Updates

Five cardiometabolic-related news items have been observed: Esperion announced it has launched a new website (esperionscience.com) featuring information about CLEAR Outcomes (view press release); Abbott received FDA 510(k) approval to add APIs to the FreeStyle Libre 2 and 3 CGM systems (view 510(k) decision letter); Novartis has initiated a Ph3 trial evaluating inclisiran vs. placebo in a primary prevention cohort (VICTORIAN-1 PREVENT; view CT.gov record); Nemaura Medical published its CY Q4 ‘22 (FY Q3 ‘23) business update (press release); and Viatris hosted its Q4 ’22 earnings call (press release; slides). Below, FENIX provides highlights and insights from the respective news items.

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Dexcom’s Project Liberty Motives Are Confusing

At ATTD 2023, Dexcom hosted a symposium where it highlighted “Project Liberty,” a follow-on R&D initiative stemming from Dexcom’s 2018 acquisition of TypeZero. Dexcom said Project Liberty is intended to move AID algorithms beyond T1DM and into a broader subset of patients with diabetes, including T2DM. However, it is not readily apparent as to Project Liberty’s business case. Below, FENIX provides thoughts and hypotheses as to what Dexcom’s strategic rationale could be regarding Project Liberty.

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Medtronic and Esperion CY Q4 ’22 Earnings Updates; Akebia Receives Another FDA Response for Vadadustat; Wegovy and Vadadustat CHMP Opinions; February CHMP Agenda

A series of diabetes-related news items have been observed: Medtronic (press release; slides) and Esperion (press release; slides) hosted their respective CY Q4 ’22 earnings calls; Akebia received another FDA response regarding the vadadustat CRL appeal (press release); and the February CHMP Agenda was posted, including vadadustat and Wegovy (potential) opinions. Below, FENIX provides highlights and insights from the respective news items, including thoughts on Medtronic’s Simplera CGM approval timing.

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Insulet Acquires Bigfoot’s Insulin Pump IP; Dexcom G7 Receives Medicare Reimbursement; Novo Initiates New Sema Pediatric Obesity Trial; Sanofi Completes $35M Investment in Provention; Sanofi Announces Change in R&D Leadership

A series of cardiometabolic-related news items were observed from Insulet, Bigfoot, Dexcom, Novo Nordisk, and Sanofi. Below, FENIX provides highlights and insights into the respective news items.

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