Tag Archives: FLOW

Viking’s Topline AE Data Scares the Street; Medtronic Q2 ‘25 Earnings; Novo Partners for Oral Peptide Research; Rezdiffra Gains EU Marketing Authorization; UK Approves Tzield; Luna Closes Series A Funding Round; Health Canada Approves FLOW; EMA Accepts NewAmsterdam’s Obicetrapib MAA

A series of cardiometabolic-related news items has been observed from Viking Therapeutics, Medtronic, Novo Nordisk, Madrigal Pharmaceuticals, Sanofi, Luna Health, and NewAmsterdam Pharma. Below, FENIX provides highlights and insights for the respective news items.

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Ozempic CKD Label and Website Analysis

FDA recently approved the Ozempic label expansion to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to CVD in adults with T2DM and CKD (view label). The approval is based on the Ph3b FLOW trial (view CT.gov record) which demonstrated a -24% reduction in the primary composite endpoint (previous FENIX insight). Below, FENIX has conducted an analysis of the updated Ozempic label and patient/HCP websites.

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Ozempic Approved in CKD; Metsera Targets IPO Valuation; Helicore Launches as Obesity Company; Hims & Hers Super Bowl DTC; BioAge Scraps Azelaprag Program; Novo Caps Insulin Prices

A series of cardiometabolic-related news items have been observed from Novo Nordisk, BioAge Labs, Metsera, Helicore Biopharma, and Hims & Hers. Below, FENIX provides highlights and insights for the respective news items.

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CHMP Denies Mounjaro OSA Indication; FLOW Positive CHMP Opinion; New Oramed Oral Insulin Study; Diamyd and FDA Align on Accelerated Approval; Noom to Offer Metformin for Weight Loss

A series of cardiometabolic-related news items have been observed from CHMP, Oramed, Diamyd Medical, and Noom. Below, FENIX provides highlights and insights for the respective news items.

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ADA 2024 Key Press Releases (June 24)

On the final day of the ADA 2024 conference, nine cardiometabolic-related news items have been observed from Novo Nordisk, Adipo Therapeutics, Trinity Biotech, Alnylam, Viking, Teva, Teladoc Health, and CHMP. Below, FENIX provides context and analysis for the announcements, including thoughts on the potential FLOW label.

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