Tag Archives: saxagliptin

Lilly Initiates Additional Ph3 Orforglipron Trial; Mounjaro Label Update; Vertex, Amarin, and Intercept Q2 ‘23 Earnings; Glenmark Receives ANDA Approval for 2.5mg and 5mg Saxagliptin; Dario Introduces GLP-1RA Obesity Program; Tandem Initiates Sigi Patch Pump Trial

A series of cardiometabolic-related news items have been observed from Lilly, Vertex, Amarin, Intercept, Glenmark, Dario, and Tandem. Below, FENIX provides highlights and insights for the respective news items.

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Diabeloop Initiates DBL-4pen Trial; Glenmark’s Generic Onglyza Receives Tentative Approval

Two cardiometabolic-related news items have been observed: Diabeloop initiated a trial evaluating its self-learning AID software via the DBL-4pen smartphone app in patients with T2DM in France (SERENIT2; view CT.gov record); and FDA granted tentative approval for Glenmark Pharma’s generic saxagliptin (Onglyza) 2.5mg and 5mg tablets (view Drugs@FDA). Below, FENIX provides highlights and insights from the respective news items, including readthrough from the Diabeloop trial for Sanofi and Novo.

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AZ’s Triple FDC (Dapa/Saxa/Met) Receives Positive CHMP Opinion

AstraZeneca announced it received a positive CHMP opinion for the FDC of dapagliflozin+saxagliptin+metformin branded as “Qtrilmet.” Recall, FDA approved AZ’s triple FDC (called Qternmet XR in the US) in May 2019. Below, FENIX provides brief thoughts on the Qtrilmet positive CHMP opinion.

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