A series of cardiometabolic-related news items have been observed from Novo, Amgen, Dexcom, and Boehringer Ingelheim. Below, FENIX provides highlights and insights for the respective news items.
Three cardio-metabolic related news items have been observed: FDA updated the Ozempic label to include ileus (intestinal blockage) as an adverse reaction reported post-approval (view updated label); AZ, BMS, Merck, and BI have reportedly agreed to participate in the first round of Medicare price negotiations (view article); and Biomea Fusion announced FDA and Health Canada cleared the expansion portion of its Ph2 COVALENT-111 study evaluating BMF-219, an oral covalent menin inhibitor, in T2DM (view press release). Below, FENIX provides highlights and insights into the respective news items.
Two cardiometabolic-related news items have been observed: Zealand Pharma hosted its Q2 ’23 earnings call (press release; slides); and TheracosBio announced a collaboration with SmithRx to offer access to Brenzavvy (bexagliflozin; view press release). Below, FENIX provides highlights and insights into the respective news items.
A series of cardiometabolic-related news items have been observed from BI and Zealand, Dario and Sanofi, MyFitnessPal and Google Health, and Diamyd Medical. Additionally, Senseonics and MannKind hosted their respective Q1 ’23 earnings calls. Below, FENIX provides highlights and insights into the respective news items.
A series of cardiometabolic-related news items have been observed from BI/Lilly, Senseonics, Novo, Merck, BI/Lifebit, Intercept, and Amarin. Below, FENIX provides highlights and insights for the respective new items.
A series of cardiometabolic-related news items have been observed: BI/Lilly announced FDA granted Breakthrough Therapy Designation (BTD) to Jardiance for the treatment of HFpEF; Metacrine announced the Ph2a trial evaluating MET642 in 180 patients with NASH has completed enrollment; and Dario Health announced it was selected as the digital health provider for a Northeast regional employer. Below, FENIX provides highlights and insights for the respective news items.
Today, BI/Lilly presented positive full results from EMPEROR-Preserved, the heart failure outcomes trial (HFOT) for Jardiance in HFpEF. While the 21% relative risk reduction augmented the clinical utility of SGLT2i in HF, the lack of benefit in patients with a LVEF ≥60% was very surprising and opens up a multitude of implications and opportunities across CV medicine. Below, FENIX provides highlights, insights, and implications from EMPEROR-Preserved that are sure to make 2022 another dynamic year for the CV global landscape.
BI/Lilly announced Jardiance received FDA approval for the treatment of HFrEF based on results from the EMPEROR-Reduced CVOT. The indication from the updated label reads “to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure and reduced ejection fraction.” Of note, the approval comes ~3 weeks ahead of the projected PDUFA date (September 9, 2021). In June 2021, BI/Lilly received EC marketing authorization for Jardiance as a treatment for adults with symptomatic chronic HFrEF.
A series of cardiometabolic-related news items have been observed: Viatris and Senseonics hosted their respective Q2 ’21 earnings calls; AstraZeneca announced EU approval of Forxiga for the treatment of CKD in adults with and without T2DM; GoodRx and BI announced an initiative to increase access to cost-savings programs for patients with T2DM and COPD; Diamyd announced the European Patent Office has granted the Diamyd’s recent patent application for treatment using GAD; and Glooko announced Prakash Menon has been appointed as the company’s Chief Technology Officer. Below, FENIX provides highlights and insights for the respective news items.
With the start of the ATTD 2021 conference, a series of cardiometabolic-related press releases have been observed from BI/Zealand, Medtronic, Metacrine, and Obatala Sciences. Below, FENIX provides highlights and insights from the respective news items.