A series of cardiometabolic-related news items have been observed from Novo Nordisk, Viking Therapeutics, AstraZeneca, Roche, and Sanofi. Below, FENIX provides highlights and insights for the respective news items.
Three cardiometabolic-related news items have been observed: The UK’s MHRA approved SELECT (view press release); Skye Biosciences hosted a virtual KOL event discussing the nimacimab obesity development program and timeline (view press release); and new Lilly obesity awareness ads have been observed. Below, FENIX provides highlights and insights for the respective news items.
Three cardiometabolic-related news items have been observed: BioAge Labs initiated a Ph2 POC study evaluating co-administered oral azelaprag QD or BID with QW SC injection of tirzepatide in obesity (STRIDES; view CT.gov record); TIXiMED announced it obtained IND approval from FDA for its oral T1DM drug, TIX100 (view press release); and Novo Nordisk reportedly will begin construction for a potential new production plant in Denmark (view article). Below, FENIX provides highlights and insights for the respective news items.
Findings from a University of Oxford study published in the Lancet demonstrated Ozempic decreased the risk of developing dementia by 48% vs. sitagliptin after one year and protected against other cognitive problems (view article; view study). For context, the study evaluated 12-month neurological and psychiatric outcomes of semaglutide vs. sitagliptin, empagliflozin, and glipizide using electronic health records. Below, FENIX provides highlights and insights into the study’s findings.
A series of cardiometabolic-related news items have been observed from Pfizer, Skye Biosciences, Adocia, and the FTC. Below, FENIX provides highlights and insights for the respective news items.
Novo Nordisk announced FDA issued a CRL regarding the QW insulin icodec BLA for the treatment of diabetes. According to the press release, the CRL outlines requests related to the manufacturing process and the T1DM indication. Novo stated it is evaluating the content of the CRL and will work closely with FDA to fulfill the requests. Of note, Novo does not expect to be able to fulfill the requests during 2024. Below, FENIX provides brief thoughts on the CRL in the context of the recent negative FDA adcom vote.
A series of cardiometabolic-related news items have been observed from Roche, Lilly, Pfizer, and the FTC. Below, FENIX provides highlights and insights for the respective news items.
A series of cardiometabolic-related news items have been observed from Novo Nordisk, Dexcom, US House of Representatives, and Esperion. Below, FENIX provides highlights and insights for the respective news items.
Three cardiometabolic-related news items have been observed: Novo Nordisk announced its CLARION-CKD Ph3 trial evaluating ocedurenone (nsMRA) failed to meet its primary endpoint (view CT.gov record; view press release); NeuroBo Pharmaceuticals announced it dosed first patients in the Part 2 MAD portion of its Ph1 trial of DA-1726 for obesity (view CT.gov record; view press release); and Hanyu Pharmaceuticals (and Hikma) announced its liraglutide ANDA has been granted tentative approval (view press release). Below, FENIX provides highlights and insights for the respective news items.
On the final day of the ADA 2024 conference, nine cardiometabolic-related news items have been observed from Novo Nordisk, Adipo Therapeutics, Trinity Biotech, Alnylam, Viking, Teva, Teladoc Health, and CHMP. Below, FENIX provides context and analysis for the announcements, including thoughts on the potential FLOW label.