Category Archives: Glucose Monitoring

Lilly Completes SURMOUNT-2 Trial; FDA Clears Libre 3 Reader; Novo Initiates Ph3 Icodec + Semaglutide Treatment Intensification Trial

Three cardiometabolic-related news items have been observed: On April 13, 2023, the ClinicalTrials.gov record for SURMOUNT-2 was updated to reflect that the trial has been completed; Abbott announced FDA cleared a standalone reader for its FreeStyle Libre 3 iCGM system (view press release); and Novo Nordisk has initiated a Ph3 T2DM trial evaluating icodec as add-on therapy to semaglutide for treatment intensification (view CT.gov record). Below, FENIX provides highlights and insights into the respective news items. 

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Abbott Recalls FreeStyle Readers

On April 4, 2023, FDA posted an announcement to its Medical Device Recalls page identifying Abbott’s recall on the FreeStyle Libre family of readers used with the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash CGMs for risk of extreme heat and fire as a Class I Recall (view FDA announcement). Below, FENIX provides brief insight into the impact of the recall.

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Senseonics Q4 ’22 Earnings and CGM Investor Event; OrsoBio Doses First Patient in Ph2 TLC-3595 Trial for Insulin Resistance

Two cardiometabolic-related news items have been observed: Senseonics hosted a CGM virtual investor event last week which coincided with the company’s Q4 2022 earnings release (press release; slides); and OrsoBio announced that the first patient has been dosed in its Ph2a clinical trial evaluating the safety and insulin sensitizing effects of TLC-3595, a selective ACC2 inhibitor (view press release; CT.gov record). Below, FENIX provides highlights and insights from the news items, including thoughts on Senseonics’s pipeline in the context of its previous commercial struggles and the evolving CGM landscape.

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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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