Category Archives: Topics

October CHMP Agenda Highlights; Pfizer Initiates Q3M Berobenatide Study; Novo Licenses New Drug Discovery Platform; Fractyl Shares 6-Month Revita Procedure Results; FDA Reaffirms Reta’s Classificaiton as a Drug; MiniMed Appoints Board; Sequel twiist AID Insulin-Treated T2DM FDA Clearance

A series of cardiometabolic-related news items has been observed from EMA, Pfizer, Novo/Ablexis, Fractyl Health, FDA/Lilly, MiniMed, and Sequel Med Tech. Below, FENIX provides highlights and insights for the respective news items.

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Novartis Terminates Ph3 Pelacarsen Studies; AZ Partners with insitro; Dexcom Publishes CONNECT RCT Results; Pfizer China-Based QM Berobenatide Obesity Study; Modular Medical Digital Learning Tool; Medtronic Finalizes MiniMed Separation; Atrogi Oral GRK2-Biased ß2-Adrenergic Modulator Data

A series of cardiometabolic-related news items has been observed from Novartis, AstraZeneca, Dexcom, Pfizer, Modular Medical, MiniMed, and Atrogi AB. Below, FENIX provides highlights and insights for the respective news items.

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Verdiva Terminates Weekly Oral GLP-1RA Maintenance Study; Two Deaths Linked to Black Market Reta; Zealand Partners with Generate; Ultragenyx Sells Two PRVs; Amgen At-Home Autoinjector MariTide Study; iBio Preclinical Activin E Data; Biomea FIH BMF-650 Data; Caspian Menin Inhibitor Development Strategy

A series of cardiometabolic-related news items has been observed from Verdiva Bio, FDA, Zealand Pharma, Ultragenyx Pharmaceutical, Amgen, iBio, Biomea Fusion, and Caspian Therapeutics/Kura Oncology. Below, FENIX provides highlights and insights for the respective news items.

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Rona Partners with Roche for ALK7-Targeting Asset; MetaVia Appoints New CMO; SAB-142 FDA Fast Track Designation

Three cardiometabolic-related news items have been observed: Rona Therapeutics entered into a partnership with Roche for an ALK7 asset to treat metabolic diseases (view press release); MetaVia appointed Sarah Browne as its new Chief Medical Officer (view press release); and SAB Bio received FDA Fast Track designation for the development of SAB-142 in Stage 3 T1DM (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Insulet Omnipod Discover Launch; October CHMP Agenda

Two cardiometabolic-related news items have been observed: Insulet launched its Omnipod Discover platform in the US (view press release), and the CHMP agenda for this month’s meeting (October 12-15) has been released (view agenda). Below, FENIX provides highlights and insights for the respective news items.

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Amgen T2DM Ph3 MariTide H2H vs. Sema Study; Oral VK2735 Ph3 Obesity Program; Ascensia Enters Another CGM Partnership

Three cardiometabolic-related news items have been observed: Amgen registered its Ph3 MARITIME-T2D-3 study evaluating MariTide H2H vs. injectable sema (view CT.gov record); Viking posted its Ph3 SUNRISE obesity program of oral VK2735 (SUNRISE 1 CT.gov record; SUNRISE 2 CT.gov record); and Ascensia entered into a commercial distribution partnership with Sava (view press release). Below, FENIX provides highlights and insights for the respective news items.

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MiniMed Initiates 16-day CGM Study; FDA Accepts Bayer’s Finerenone Non-T2DM CKD sNDA; Ribo Life Science Submits Ph1 Application for INHBE siRNA Obesity Study in EU

Three cardiometabolic-related news items have been observed: MiniMed has registered a new study of its next-gen extended-wear CGM, called Unity (view CT.gov record); FDA accepted Bayer’s sNDA for finerenone in non-T2DM CKD (view press release); and Suzhou Ribo Life Science submitted a Ph1 CTA in the EU for its INHBE siRNA in obesity (view press release). Below, FENIX provides highlights and insights for the respective news items.

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