Tag Archives: FDA

FDA Releases Status on GLP-1RA Supply; AZ Initiates Baxdrostat/Dapa Trial in CKD and CV; TIXiMED Announces $2.65M Investment

Three cardiometabolic-related news items have been observed: FDA clarified the tirzepatide shortage resolution and impact on compounding pharmacies (view report); AstraZeneca initiated a Ph3 baxdrostat/dapagliflozin renal outcomes and CV mortality trial (view CT.gov record); and TIXiMED announced a $2.65M Helmsley Charitable Trust investment (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Zynquista Negative Adcom Vote; Novo STEP-9 Results Published; Wegovy Removed from FDA Shortage List; Amgen, Madrigal, Biomea, Teladoc, and Amarin Q3 ’24 Earnings; BI/Gubra Discontinue NPY2 for Obesity; Inventiva Positive DMC Recommendation for Ph3 MASH Trial

A series of cardiometabolic-related news items have been observed from Lexicon, Novo Nordisk, Amgen, Madrigal, Biomea Fusion, BI/Gubra, Inventiva, Teladoc, and Amarin. Below, FENIX provides highlights and insights for the respective news items.

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FDA Tirzepatide Shortage Removal Update; Catalent Sells Site to Ardena; LifeVantage Launches MindBody GLP-1 System; Inventiva Receives Additional Funding for MASH; October CHMP Agenda; Sagimet Publishes FASCINATE-2 Data; Q Bio Appoints Jeff Brewer as CEO

A series of cardiometabolic-related news items have been observed from FDA, Catalent/Ardena, LifeVantage Corporation, Inventiva, EMEA, Sagimet Biosciences, and Q Bio. Below, FENIX provides highlights and insights for the respective news items.

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FDA Removes Tirzepatide from Shortage List

FDA announced the tirzepatide shortage has been resolved and provided clarifications for compounding manufacturers. According to the announcement, FDA confirmed with Lilly that their stated product availability and manufacturing capacity can meet the present and projected national demand. However, patients and prescribers may still see intermittent localized supply disruptions as the products move through the supply chain from Lilly and distributors to local pharmacies. Below, FENIX provides brief insight into the impact of the FDA announcement.

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Lexicon Zynquista Adcom; Sesame to Offer Compounded Semaglutide

Two cardiometabolic-related news items have been observed: Lexicon announced an FDA adcom for Zynquista in T1DM with CKD has been set for October 31, 2024 (view press release); and Sesame announced it will offer compounded Wegovy through Success by Sesame, its new weight-loss program (view press release). Below, FENIX provides highlights and insights for the respective news items.

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ADA 2024 Key Press Releases (June 21)

On the first day of ADA 2024, three cardiometabolic-related news items were observed: Lilly announced detailed results from its Ph3 SURMOUNT-OSA trial presented at ADA 2024 and published in the NEJM (view press release); Lexicon announced it resubmitted the sotagliflozin NDA for adjunctive treatment of T1DM and CKD (view press release); and Vertex Pharmaceuticals announced new data from its Ph1/2 trial of VX-880 (view press release). Below, FENIX provides context and insight into the respective news items.

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