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Roche

Roche’s Elecsys pTau181 Test Receives the US FDA’s Clearance to Rule Out Alzheimer’s Disease

Shots:The US FDA has cleared the Elecsys pTau181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology in individuals (≥55yrs.)Elecsys pTau181 was evaluated in a non-interventional study of 312 participants, showing 97.9% negative predictive value (NPV) in an early disease-stage, low-prevalence populationElecsys pTau217 is an in-vitro diagnostic…

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Eli lilly

Eli Lilly Reports Kisunla (Donanemab) Approval in the EU to Treat Early Symptomatic Alzheimer’s Disease

Shots:The EC has approved Kisunla to treat early symptomatic Alzheimer’s disease in adults with mild impairment or dementia & confirmed amyloid pathology who are ApoE4 heterozygotes or non-carriersApproval was based on P-III (TRAILBLAZER-ALZ 2) study (n=1736, ≥18mos.) & P-IIIb (TRAILBLAZER-ALZ 6) trial (n=843, 60-85yrs.) assessing Kisunla (QM) vs PBO in AD ptsThe TRAILBLAZER-ALZ 2 trial showed…

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Avant Technologies and Austrianova Form Joint Venture Klothonova to Develop Klotho-Based Cell Therapies

Shots:Avant Technologies and Austrianova signed a joint venture and licensing agreement to form Klothonova, a 50/50 Nevada-based Joint Venture focused on developing cell-based therapies using encapsulated Klotho-producing cellsUnder the terms of the agreement, Klothonova will leverage Austrianova’s proprietary cell-encapsulation technology to develop and commercialize therapies for Alzheimer’s disease, heart disease, cancer, kidney disease,…

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VectorY Therapeutics Collaborates with Shape Therapeutics to Develop Vectorized Antibodies for Neurodegenerative Diseases

Shots:VectorY has entered into an option & license deal with Shape to assess Shape’s SHP-DB1 (AAV capsid) for vectorized Abs payloads against 3 targets & may secure an exclusive license for their delivery if evaluation succeedsAs per the deal, VectorY will handle development & commercialization of resulting therapies in exchange for an upfront…

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Veravas

Veravas Launches VeraBIND Tau to Detect Alzheimer’s Disease & other Tauopathies

Shots:Veravas has launched VeraBIND Tau to detect both symptomatic & pre-symptomatic pts with Alzheimer's disease (AD) or other tau-related neurodegenerative disorders (tauopathies)In an analytical verification study, VeraBIND Tau showed 96% sensitivity, 90% specificity, & 92% agreement with tau PET imaging, detecting Alzheimer’s-related tau & offering VeraBIND Tau score, a semi-quantitative measure of pathologically…

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