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Innovative Nipocalimab Trial for HDFN Treatment Powered by BillionToOne

XTalks

BillionToOne, a company specializing in molecular diagnostics, has partnered with Janssen Research & Development, LLC, a Johnson & Johnson division, to conduct the AZALEA Phase III clinical trial globally. The trial is set to occur across the US, the European Union (EU) and selected global locations.

Trials 97
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FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD)

The Pharma Data

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. Approval supported by one of the largest clinical trial programmes undertaken for this rare disease. Basel, 17 August 2020.

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The Utility of Liquid Biopsy in Oncology Clinical Trials

XTalks

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. These tumor-derived entities are used to derive genomic and proteomic data. Concentration of CTCs in Cancer Patients.

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Roche’s anti-amyloid beta antibody gantenerumab granted FDA Breakthrough Therapy Designation in Alzheimer’s disease

The Pharma Data

Roche announced that gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of people living with Alzheimer’s disease (AD).

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Roche’s Early Alzheimer’s Blood Test Gets FDA Breakthrough Device Designation

XTalks

There are currently no FDA-authorized blood tests for detecting Alzheimer’s disease. The Elecsys pTau217 assay is being developed for various use case scenarios, including clinical trials or determining eligibility for approved disease-modifying therapies. The disease has an estimated $360 billion cost to the US economy.

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Brain Awareness Week 2024: A Spotlight on Brain Health and New Treatments for Neurological Diseases

XTalks

Brain Awareness Week 2024 , taking place March 11 to 17 this year, is a global campaign that aims to demystify the complexities of the human brain and promote the significance of neuroscientific research. This relates to neurological conditions like dementia and Alzheimer’s disease, which account for up to 70 percent of dementia cases.

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Can vertical AI advance cell and gene therapies? 

Drug Discovery World

With human clinical trials with AI-designed drugs now ongoing, it’s only a matter of time until the FDA approves its first AI-designed drug. Andrew Busey , Co-Founder, Form Bio discusses why vertical AI is set to reshape the cell and gene therapy sector. Here’s what this means for pharmaceutical leaders and patients.