A series of cardiometabolic-related news items have been observed from FDA/Lexicon, Pfizer, Novartis, Sanofi, Amgen, and Sagimet Biosciences. Below, FENIX provides highlights and insights for the respective news items.
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.
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.
A series of cardiometabolic-related news items have been observed from Dexcom, Abbott, Novartis, and the Biden Administration. Below, FENIX provides highlights and insights for the respective news items.
A series of cardiometabolic-related news items have been observed from Pfizer, Novo Nordisk, D&D Pharmatech, Skye Bioscience, and Intarcia. Below, FENIX provides highlights and insights for the respective news items.
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.
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.
Today, FDA held an Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to discuss the use of Novo Nordisk’s QW insulin icodec in T1DM patients, and panelists voted 4-7 against the icodec benefit/risk profile in T1DM patients. The split vote is largely unsurprising in the context of FDA’s concerns raised in the adcom briefing documents (previous FENIX insight). Below, FENIX provides highlights and insights from the icodec adcom, including additional thoughts on how a T2DM-only icodec indication would be a significant win for Novo (and Lilly).
A series of cardiometabolic-related news items have been observed from Fractyl Health, 89bio, Esperion, and Lexicon. Below, FENIX provides highlights and insight for the respective news items.
A series of cardiometabolic-related news items have been observed from Madrigal, Vertex, Ionis, Esperion, Scholar Rock, and Tandem. Below, FENIX provides highlights and insights for the respective news items.