Two cardiometabolic-related news items have been observed; Novartis (press release; slides) hosted its Q3 ’22 earnings call; and Adocia issued a press release for its Q3 ’22 earnings, though it did not host an associated webcast. Below, FENIX provides highlights and insights from the respective new items.
Biocon disclosed that the company received a second CRL from FDA regarding its bs-aspart BLA filed by Viatris (view announcement). For context, Biocon received its first bs-aspart CRL from FDA in January 2022 (view Biocon announcement). In the same announcement, Biocon noted its integrated insulin manufacturing facility in Malaysia was approved by EMA following a July 2022 site inspection. Below FENIX provides brief thoughts on the new CRL and potential impact on the bs-aspart approval timeline.
Two cardiometabolic-related news items have been observed: Nimbus Therapeutics announced a new partnership with Lilly to develop novel small molecule therapies; and Arecor announced positive topline results from its second Ph1 AT247 trial comparing its ultra-rapid-acting insulin (AT247) to Novolog and Fiasp in T1DM patients. Below, FENIX provides highlights and insights for the respective new items.
Three cardiometabolic-related news items have been observed: Ypsomed announced the launch of a smartphone bolus delivery feature for its mylife YpsoPump using the mylife App; Lannett announced it completed subject dosing in its Ph1 bs-glargine pivotal trial (view CT.gov record); and Madrigal announced the initiation of a Ph3 MAESTRO-NASH Outcomes study evaluating the effect of QD oral 80mg resmetirom compared to placebo in patients with compensated NASH cirrhosis (view CT.gov record). Below, FENIX provides context and insight on the respective news items.
A series of cardiometabolic-related updates have been observed: Beta Bionics has reportedly laid off an unknown number of employees (view LinkedIn post); a Novo-sponsored Ph3 trial evaluating Ozempic and lower-dose insulin glargine has been observed (SUSTAIN OPTIMIZE; view CT.gov record); Novartis announced plans to spin off Sandoz (press release); Lannett (press release) and Adocia (press release) released their Q2 ’22 earnings; and Hygieia announced the appointment of a new CEO. Below, FENIX provides context and insight on the respective news items.
Two cardiometabolic-related news items have been observed: Medtronic (press release; slides) released their CY Q2 ‘22 (FY Q1 ‘23) earnings, including updates to the ongoing FDA warning letter situation; and Glytec announced a partnership with CPS to offer glycemic management technology to HCPs (press release). Below, FENIX provides context and insight on the respective news items.
Three cardiometabolic-related news items have been observed: Xeris Biopharma (press release), Zealand (press release; slides), and MannKind (press release; slides) hosted their Q2 ’22 earnings calls. Below, FENIX provides highlights and insights for the respective new items.
A series of diabetes-related news items have been observed: Insulet announced the full market release of its Omnipod 5 hybrid closed-loop system; Arecor is acquiring Tetris Pharma who is partnered with Xeris for UK/EU/CH Ogluo commercialization (view Xeris press release); and Sanofi/Optum have partnered to reduce the cost of insulin to uninsured patients (press release). Below, FENIX provides context and insight on the respective news items.
A series of cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (July 18-21) has been released and it appears Lilly’s tirzepatide is up for an opinion; a third trial from Lilly’s Ph3 QW insulin program (BIF; LY3209590) has been observed (view CT.gov record); and UnitedHealthcare announced that starting January 1, 2023, it will eliminate out-of-pocket costs for certain preferred prescription drugs, including insulin and four medical emergency drugs. Below, FENIX provides highlights and insights for the respective new items.
A series of cardiometabolic-related news items have been observed from Vertex, Medtronic, Insulet, Roche, Ionis, and state of California. Below, FENIX provides highlights and insights for the respective new items.