The CHMP agenda for this month (December 7-10) has been released, and it includes two notable items, potential CHMP opinions for Biocon/Mylan’s insulin aspart and Xeris’s glucagon, as well as several other agenda items. Below, FENIX provides diabetes-related highlights and insights from the December 2020 CHMP agenda.
Insulet (press release), Mannkind (press release), and Lannett (press release) hosted their respective Q3 ’20 earnings calls. Of note, Insulet provided updates to its Omnipod 5 development plans, including the recent initiation of a T2DM feasibility study. Furthermore, following a meeting between Lannett and FDA in June 2020, Lannett said it is finalizing the trial protocol evaluating its bs-glargine in healthy volunteers. Below, FENIX provides highlights and insights from the calls.
Novo Nordisk hosted its post-Q3 ’20 earnings event in London (see previous FENIX insight on Q3 ’20 Novo earnings from October 30). Below, FENIX provides highlights and insights from the Novo earnings call beyond what was discussed on October 30, including insight into the impending semaglutide NASH Ph3 program initiation and thoughts on the high-dose oral semaglutide approval timeline.
Novo Nordisk hosted its Q3 ’20 earnings call (press release; slides) and provided updates across its pipeline and commercial activities, including the ongoing Rybelus launch, positive ziltivekimab Ph2b topline results, and Ph1 initiation for a novel glucose-responsive insulin. Additionally, Novo disclosed plans to use its PRV for the semaglutide 2.4mg obesity FDA submission. Below, FENIX provides highlights and thoughts from the call, including insight into a hidden importance of using the PRV for the sema 2.4mg obesity filing.
Lexicon (press release) and Sanofi (press release; slides) hosted their respective Q3 ’20 earnings calls and provided updates to their diabetes businesses. Additionally, Lifescan announced a partnership with Cecelia Health to provide coaching and telehealth services to OneTouch users. Below, FENIX provides highlights and insights from the respective news items, including how the upcoming Entresto FDA adcom could renew M&A interest in Lexicon.
Lilly, Novartis, Pfizer, and Merck each hosted their respective Q3 ’20 earnings calls and provided updates across a variety of topics. Importantly, it was disclosed that FDA has requested an advisory committee meeting to discuss Novartis’s Entresto PARAGON-HF submission. Below, FENIX provides highlights and insights from the respective earnings calls.
The CHMP agenda for this month (October 12-15) has been released, and it includes one notable item, DAPA-HF, as well as several other agenda items. Below, FENIX provides diabetes-related highlights and insights from the October 2020 CHMP agenda.
A series of diabetes-related news items have been observed: Lilly and Dexcom announced a partnership to launch a joint program for US HCPs, focusing on Lyumjev and G6 CGM’s role in PPG control; Medtronic announced its former CEO, Omar Ishrak, will retire as Executive Chairman and Chairman of the Board, succeeded by CEO, Geoff Martha; Patia Biopharma and Precision Diabetes announced a partnership for diabetes diagnostics; and Capillary Biomedical announced it has received a $1.5M loan from the Helmsley Charitable Trust to conduct trials for an extended-wear infusion set. Below, FENIX provides highlights and insights from the respective news items.
A series of diabetes-related news items have been observed: Senseonics announced the sPMA filing of its 180-day implantable CGM; Beyond Type 1 launched GetInsulin.org as a tool to connect PWD to insulin assistance programs and low-cost insulin solutions (press release); and Kidney Disease: Improving Global Outcomes (KDIGO) recently released its first-ever T2DM CKD guidelines, called 2020 Clinical Practice Guideline for Diabetes Management in CKD (view press release; view complete document here). Below, FENIX provides highlights and insight from the respective news items.
A series of diabetes-related news items have been observed: Apple featured a T1DM patient story during the Apple Watch portion of its event; BI/Lilly announced Jardiance has received Fast Track designation for its EMPACT-MI study; Adocia announced positive topline results from its Ph1b M1Pram extension study in PWT1D; Welldoc and the University of Maryland’s Center for Health Information and Decision System (CHIDS) announced findings from a user engagement analysis; Oramed announced results from a diabetes market survey; and Diamyd received $13.9M from its divestment in Companion Medical. Below, FENIX provides highlights and insights from the respective news items.