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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,…
September 4, 2026

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Eisai and Biogen Report EU Launch of Leqembi (Lecanemab) to Treat Alzheimer’s Disease
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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…
September 3, 2026

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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…
September 3, 2026

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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…
September 3, 2026

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Novartis and Alteogen Partner for ALT-B4 to Advance SC Formulations of Multiple Products

Shots: Alteogen has entered into an option & license agreement with Novartis for the development & commercialization of SC products leveraging ALT-B4 powered by Alteogen's Hybrozyme tech As per the deal, Novartis can obtain exclusive rights to develop & commercialize SC formulations of multiple products using Alteogen’s ALT-B4, with Alteogen eligible for ~$3.223B in option…
September 3, 2026

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Akeso and Summit Report P-III (HARMONi-2) Trial Data on Ivonescimab for PD-L1-Positive Advanced NSCLC

Shots: Akeso and Summit has reported the P-III (HARMONi-2/AK112-303) trial data assessing ivonescimab monotx. vs Keytruda in Chinese pts with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression Trial showed improvement in OS (2EP), with results to be presented in future. In the primary analysis, trial met it 1EP of improved PFS,…
September 3, 2026

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uniQure Reports the US FDA BLA Submission for Ifezuntirgene Inilparvovec to Treat Huntington’s Disease

Shots: The US FDA has received a BLA for the accelerated approval of ifezuntirgene inilparvovec (AMT-130) for the treatment of Huntington’s disease, plus a request for Priority Review BLA was supported by the 3yr. data analysis from the P-I/II trial of AMT-130 vs a propensity score-matched external control derived from the Enroll-HD natural history database;…
September 2, 2026

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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…
September 2, 2026

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Styx Biotechnologies Partner with ZoeNCure Therapeutics to Advance ADC Development

Shots: Styx Biotechnologies has entered into a strategic agreement with ZoeNCure Therapeutics to accelerate selected Styx ADC programs toward first-in-human clinical studies for multiple solid tumor indications The collaboration gives Styx a capital-efficient path to advance selected ADC assets through coordinated preclinical, CMC, regulatory & clinical activities while preserving opportunities for global development & strategic partnering As…
September 2, 2026

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