Three cardiometabolic-related news items have been observed: Lilly (press release; slides), Merck (press release; slides), and Roche (press release; slides) hosted their respective Q4 ’22 earnings calls. Below, FENIX provides highlights and insights from the earnings calls.
FDA announced the approval of GSK’s daprodustat as Jesduvroq for the treatment of CKD anemia in dialysis-dependent (DD) patients. The approval comes after multiple CRLs for Fibrogen/AZ’s roxadustat and Akebia/Otsuka’s vadadustat. The Jesduvroq label has not yet been observed. Below, FENIX provides brief thoughts on the Jesduvroq approval.
A series of cardiometabolic-related news items have been observed. Amgen (press release; slides), Novartis (press release; slides), and Lannett (press release) hosted their respective Q4 2022 earnings calls. Below, FENIX provides highlights and insights from the earnings calls.
Novo Nordisk hosted its Q4 ’22 earnings call (press release; slides) and provided updates across its business, including Wegovy/Ozempic supply, GLP-1RA market dynamics, new QW insulin icodec data, and more. Below, FENIX provides highlights and insights from the call.
A series of cardiometabolic-related news items have been observed from Pfizer, Lilly, Fractyl Health, Sciwind, and Lifescan. Below, FENIX provides highlights and insights into the respective news items including thoughts on Pfizer’s oral GLP-1RA selection and and Lilly’s strategy for conducting SURPASS-SWITCH-2.
Four cardiometablic-related news items have been observed: Viatris’s generic dapagliflozin received a positive CHMP opinion for the treatment of T2DM, HF, and CKD (view opinion); Lilly’s Trulicity received a positive CHMP opinion for a label extension to include patients ages 10 years and older (view opinion); Medtronic’s wearable partner, Rockley Photonics Holdings Limited, has filed for bankruptcy (view Form 8-K); Nemaura announced it has entered into a definitive agreement of ~$8.4M registered direct offering and concurrent private placement with two healthcare-focused US institutional investors (view press release). Below, FENIX provides highlights and insights including thoughts on an acquisition opportunity for Medtronic.
Two cardiometablic-related news items have been observed: The Diabetes Research Institute announced the appointment of its new scientific director, Matthias von Herrath (view press release; LinkedIn); and Nemaura Medical announced it has received an initial purchase order for 5,000 proBEAT subscriptions from HealthFleet Inc. (view press release). Below, FENIX provides highlights and insights including commentary on Matthias von Herrath’s potential impact on the DRI’s T1DM mission in the context of his current role as VP and Senior Medical Officer for Novo Nordisk.
A series of cardiometabolic-related news items were observed from Tidepool, Lilly, Novo, Embecta, AGC Biologics, and Nemaura. Additionally, Abbott and J&J hosted Q4 ’22 earnings calls. Below, FENIX provides highlights and insights into the respective news items including commentary on why the claims against Novo’s marketing practices seem unfounded.
Three cardiometabolic-related news items have been observed: TheracosBio announced FDA approved Brenzavvy (bexagliflozin), a QD 20mg oral SGLT2i, for the treatment of T2DM (view press release; label); Tandem announced it completed the acquisition of AMF Medical (view press release); and the CHMP agenda (view here) for this month’s meeting (January 23-26) has been released. Below, FENIX provides highlights and insights into the respective news items including an in-depth analysis of Brenzavvy could be another Nesina.
BI/Lilly announced FDA accepted the Jardiance (empagliflozin) sNDA for the treatment of adults with CKD. According to the press release, the sNDA is based on results from the Ph3 EMPA-KIDNEY trial which demonstrated Jardiance significantly reduced the risk of kidney disease progression or CV death in adults with CKD (view CT.gov record; previous FENIX insight). Below, FENIX provides brief thoughts regarding the EMPA-KIDNEY sNDA filing and the projected PDUFA date.