Category Archives: Other

Beta Bionics Insulin-only iLet Pivotal Trial Results @ ATTD 2022; Vertex’s Ph1/2 VX-880 Trial Placed on Clinical Hold

Two cardiometabolic-related news items have recently been observed: Beta Bionics presented results from its insulin-only bionic pancreas pivotal trial at ATTD 2022 (press release); and Vertex issued a press release detailing updates to its Ph1/2 VX-880 trial, including that FDA has placed a clinical hold on the study (press release). Below, FENIX provides highlights and insights from the respective news items.

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Novo, Dexcom, AZ, Sanofi, Biocon, and Teladoc Q1 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Novo (press release; slides), Dexcom (press release; slides), AZ (press release; slides), Sanofi (press release; slides), Biocon (press release), and Teladoc (press release; slides) hosted their respective Q1 ’22 earnings calls. Below, FENIX provides highlights and insights from the respective earnings calls.

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Novartis Q1 ’22 Earnings Update

Novartis hosted its Q1 ’22 earnings call (press release; slides) and provided brief updates to its CVRM business, including Entresto’s market performance and Leqvio’s commercialization. Additionally, management stated that the Sandoz strategic review remains in progress and reiterated expectations to provide an update by EOY. Below are highlights from the call.

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Daprodustat NDA Accepted by FDA; Sean Saint Looks to Do It Again; April 19-22 CHMP Agenda; J&J Q1 ’22 Earnings Update

Several cardiometabolic-related news items have recently been observed: GSK announced FDA accepted the daprodustat NDA for the treatment of patients with anemia due to CKD; Sean Saint has started a new company called Luna Diabetes (view website); the CHMP agenda for this month’s meeting (April 19-22) has been released; and J&J hosted their Q1’ 22 earnings call (press release; slides). Below, FENIX provides highlights and insights for the respective new items.

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New Medtronic 780G + Lyumjev Trial; Xigduo XR DAPA-CKD sNDA approved; Galectin NASH Trial to Continue; Sciwind Initiates Ph1 Oral GLP-1RA Trial

A series of cardiometabolic-related news items have been observed: a Medtronic-sponsored study evaluating the use of Lilly’s Lyumjev in the MiniMed 780G AID system has been observed (view CT.gov record); the Xigduo XR (dapagliflozin + metformin) DAPA-CKD sNDA has recently been approved (view updated label); Galectin Therapeutics reported positive feedback from its first DSMB meeting for its Ph2b/3 NAVIGATE study evaluating belapectin in NASH (press release); and Sciwind Biosciences announced it has started dosing patients in its Ph1 MAD study evaluating the company’s investigational oral GLP-1RA (XW004; ecnoglutide) in healthy volunteers. Below, FENIX provides highlights and insights for the respective new items.

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Viatris Glargine Recalled; Carbon Health Launches Diabetes Management Program

Two cardiometabolic-related news items have been observed: Viatris announced a voluntary recall of one batch of its unbranded insulin glargine U100 10 mL vials due to a potential missing label; and Carbon Health announced the launch of its personalized diabetes management program. Below, FENIX provides highlights and insights for the respective new items.

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Apple Watch Reportedly Faces Glucose Monitoring Delays; Diabeloop to Adapt AID Software for Insulin Pens; MediciNova to Initiate Ph2 NAFLD Trial

Three cardiometabolic-related news items have been observed: It has been reported that Apple has been experiencing development problems with its blood glucose monitoring feature for its Apple Watch (view article); Diabeloop announced plans to adapt its AID software for insulin pens via a new smartphone app (DBL-4pen); and, MediciNova, Inc., announced FDA has completed its review of the company’s Ph2 clinical trial protocol to evaluate MN-001 (tipelukast) for the treatment of patients with NAFLD, T2DM, and hypertriglyceridemia. Below, FENIX provides highlights and insights for the respective new items.

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Merck Hosts Investor Event Highlighting CV Portfolio and Pipeline

Yesterday, Merck hosted an investor event (view presentation replay; view slides; view fact sheet) providing an overview of the company’s CV portfolio and pipeline. During the event, Merck highlighted eight potential new approvals across its CV pipeline, including its ongoing late-stage clinical programs in ASCVD, HF, PAH, thrombosis, and ESRD. In particular, Merck discussed its oral PCSK9i (MK-0616), currently in Ph2 development for hypercholesterolemia, as well as vericiguat (Verquvo) for symptomatic chronic HF. Below, FENIX provides highlights and insight from the call, including thoughts on Merck’s seemingly renewed focus on its CV business.

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AZ/Ionis Ph2b Data @ ACC 2022; Novartis Restructures Pharma Business; Eversense E3 Launched in the US; Dexcom ONE to Launch in UK; New Sota and Kerendia Subanalyses @ ACC 2022; Fractyl Receives IDE for Second Pivotal Trial

A series of cardiometabolic-related news items have been observed from AZ/Ionis, Novartis, Ascensia/Senseonics, Dexcom, Lexicon, Bayer, DiaMedica, and Fractyl. Below, FENIX provides highlights and insights for the respective new items.

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