Skip to content Skip to footer

NEWS

United Imaging Healthcare Receives CE Mark for Dual Wide-Coverage CT Systems
Shots: United Imaging Healthcare has received CE Mark certification for uCT SiriuX and uCT SiriuX Ultrix, described as the world’s first dual wide-coverage CT family, enabling commercial availability across the EU Built on a Twin-Ring Gantry architecture, the systems combine dual-wide 16cm Ultrix detectors with 2 liquid-metal-bearing X-ray tubes to support synchronized whole-organ dynamic imaging,…
Eisai and Biogen Report EU Launch of Leqembi (Lecanemab) to Treat Alzheimer’s Disease
Biogen and Eisai Report NMPA Approval of Leqembi (SC) as an Initiation Dose for Early Alzheimer’s Disease
Shots: The NMPA has approved Leqembi (SC autoinjector/SC-AI) as an initiation dose administered as 500mg given QW as two consecutive 250mg injections, each delivered in ~15secs, for the treatment of early Alzheimer's disease  Approval was supported by 18mos. P-III Clarity AD data & multiple SC administration sub-studies (incl. Chinese cohort), with SC-AI 500mg (QW) showing…
Teva Reports Topline P-IIa Trial Results on TEV ‘408 in Celiac Disease
Shots: Teva has reported topline P-IIa trial results assessing TEV ‘408 in adults with celiac disease on a gluten-free diet (GFD) with minimal intestinal damage; additional analyses are underway The trial met its 1EP, showing prevention of gluten-induced intestinal damage at Wk. 8 following a single SC dose & improving Vh:Cd ratio, with least squares (LS)…
Heartvue.ai and Innolitics Receive FDA 510(k) Clearance for Heartvue.Proton
Shots: The US FDA has granted 510(k) clearance (K260811) to Heartvue.Proton, a machine learning-powered platform for viewing, post-processing & quantitative evaluation of cardiovascular MR images  The platform automates 2D linear dimensions, ventricular volumes & ejection fraction, and blood flow quantification, while keeping results under physician review. It integrates with hospital PACS & EHR systems to…
GSK Licenses HUTCHMED’s HMPL-A830 Outside Greater China in a ~$1.295B Deal
Shots: HUTCHMED has granted GSK worldwide rights to develop & commercialize HMPL-A830 (excl. Mainland China, Hong Kong, Macau and Taiwan), with clinical development initially focussing on colorectal, pancreatic & lung cancer indications As per the deal, HUTCHMED will be responsible for the global P-I program, (expected to start in H2’26), while GSK subsidiary will handle…
Evotec and Plectonic Partner on Next-Generation T-Cell Engagers for Solid Tumors
Shots: Evotec and Plectonic Biotech have entered a research collaboration to explore a novel immunotherapy approach for solid tumors by combining Plectonic’s programmable Logibody technology with Evotec’s BiTco platform Plectonic’s Logibody uses multi-antigen tumor signatures to selectively activate T cells, while Evotec’s BiTco platform uses a non-blocking CD2 antibody to enhance T-cell activity, tumor killing…