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Intellia Therapeutics
Intellia Therapeutics Reports the First Patient Dosing in P-III (MAGNITUDE-2) Trial of Nexiguran Ziclumeran for ATTRv-PN
Shots: Intellia has reported the first pts dosing in its P-III (MAGNITUDE-2) trial assessing nexiguran ziclumeran (nex-z) for hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN); BLA submission is expected in 2028 Trial will assess nex-z (55mg infusion) vs PBO in ~50 ATTRv-PN pts to evaluate modified neuropathy impairment score & change in serum TTR levels as…
April 7, 2025
Ethris & Lonza
Ethris Partners with Lonza to Develop Intranasal Spray-Dried mRNA Vaccines Against Respiratory Diseases
Shots: Ethris has entered into a collaboration agreement with Lonza to develop room-temperature stable, spray-dried formulations of mRNA-based vaccine candidates designed for mucosal delivery in pts with respiratory diseases As per the deal, Lonza will support Ethris’ vaccine candidates, which are based on Ethris’ stabilized non-immunogenic mRNA (SNIM RNA) & stabilized lipid nanoparticles (SNaP LNP)…
April 7, 2025
AliveDx
AliveDx Seeks the US FDA’s 510(k) Clearance for MosaiQ AiPlex Connective Tissue Diseases (CTDplus) Multiplex Microarray
Shots: The US FDA has received 510(k) application for MosaiQ AiPlex CTDplus multiplex microarray to improve & accelerate diagnosis of connective tissue diseases (CTDs) CTDplus diagnose CTDs using just 10μL of sample in one step, with its CTD microarray having 15 markers in each panel per pts—DFS70/LEDGF, CCP, dsDNA, Sm, Sm/RNP, U1RNP, Chromatin, Ribosomal P,…
April 7, 2025
Ablbio & GSK
ABL Bio Licenses Grabody-B Brain Delivery Platform to GSK for ~$2.76B (£2.15B)
Shots: ABL Bio has entered into a global licensing agreement with GSK for its Grabody-B BBB shuttle platform to develop therapies targeting various novel pathways using antibodies, siRNA, & ASOs for neurodegenerative diseases As per the deal, GSK will handle preclinical & clinical activities, manufacturing, & marketing of the potential programs in exchange for ~$99.4M,…
April 7, 2025
Avita Medical
AVITA Medical Launches Cohealyx for Wound Healing in the US
Shots: AVITA Medical has launched Cohealyx, collagen-based dermal matrix in the US Cohealyx is currently being evaluated in the post-market Cohealyx I trial (enrolment ongoing) to further assess clinical outcomes, wound bed preparation for definitive closure, & patient recovery timelines Cohealyx, developed by AVITA & Regenity Biosciences, is designed to support cellular migration & revascularization, allowing…
April 4, 2025
Netramark & Worldwide Clinical Trials
NetraMark Join Forces with Worldwide Clinical Trials to Redefine Clinical Trial Design Using NetraAI Platform
Shots: NetraMark and Worldwide Clinical Trials have entered into a global agreement to utilize NetraMark’s NetraAI platform to advance clinical trial design As per the deal, NetraAI will initially support P-II neuroscience & oncology trials, plus select P-III studies conducted by Worldwide, with broader access extended to Worldwide’s sponsors across all therapeutic areas & trial…
April 4, 2025
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