A series of cardiometabolic-related news items has been observed from Roche, Viking Therapeutics, Novo Nordisk, and Boehringer Ingelheim. Below, FENIX provides highlights and insights for the respective news items.
Three cardiometabolic-related news items have been observed: Viatris successfully challenged Novo Nordisk’s semaglutide patent (view court filing); Novo Nordisk registered a new Ph3 study of icodec in T1DM (view CT.gov record); and TIXiMED appoints new advisors for the development of its TIX100 program (view LinkedIn post). Below, FENIX provides highlights and insights for the respective news items.
Two cardiometabolic-related news items have been observed: AstraZeneca announced a $50B investment in US-based manufacturing facilities (view press release); and Madrigal Pharmaceuticals announced it secured $500M credit to primarily support its MASH pipeline expansion (view press release). Below, FENIX provides highlights and insights for the respective news items.
Three cardiometabolic-related news items have been observed: The CHMP agenda for this month’s meeting (July 21-24) has been released (view here); Medtronic announced its MiniMed 780G pump received CE Mark for ages 2+ years of age, T2DM, and during pregnancy (view press release); and FDA announced Dexcom’s CGM receivers have been recalled for faulty alert sounds (view press release). Below, FENIX provides highlights and insights for the respective news items, including thoughts on Novo’s EU semaglutide MASH regulatory strategy.
In the seventh installment of FENIX’s Obesity Spotlight Series, FENIX has conducted a deep dive analysis of Merck’s current position in the obesity market. The analysis includes insights into Merck’s strategy to replace Keytruda revenue and how Merck may focus its obesity efforts on a FDC approach.
A series of cardiometabolic events has been observed from Abbott, Novartis, Biomed Industries, and Bristol Myers Squibb/Pfizer. Below, FENIX provides highlights and insights for the respective news items.
Two cardiometabolic-related items have been observed: Lifescan entered into a Restructuring Support Agreement with its equity partner to restructure debt (view press release); and Madrigal Pharmaceuticals has been granted a US patent for Rezdiffra’s weight-based dosing regimen for the treatment of noncirrhotic MASH (view press release). Below, FENIX provides highlights and insights for the respective news items.
Two cardiometabolic-related news items have been observed: Hengrui Pharma and Kailera Therapeutics announced topline data from Hengrui’s Ph3 obesity study of its SC GLP-1/GIP dual agonist in China (view press release; view CT.gov record); and Currax Pharmaceuticals has partnered with GoodRx for cash-pay Contrave (view press release). Below, FENIX provides highlights and insights into the respective items.
Three cardiometabolic-related news items have been observed: AstraZeneca announced positive Ph3 topline results for baxdrostat in hypertension (view press release; view CT.gov record), Bayer announced FDA approval of Kerendia’s (finerenone) HEpEF indication (view press release), and Mattel announced the launch of a Barbie with diabetes (view press release). Below, FENIX provides highlights and insights for the respective news items.
FDA announced it has published more than 200 CRLs to increase transparency. The CRLs were issued to applications submitted between 2020 and 2024, and all are for drugs that have since gained approval from the agency, a Department of Health and Human Services spokesperson told Fierce Biotech (view article). Below, FENIX provides an overview of select CRLs and brief insight into the FDA openness policy.