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Clinical Development

Eli Lilly Focus on Phase III Trial for Alzheimer’s Treatment Following FDA Fast Lane Setback

The FDA ‘specifically requested’ data from at least 100 patients who received a minimum 12 months’ treatment of Lilly’s drug donanemab before the approval process could progress further.
Clinical Diagnostics

Long-Read Sequencing Named 'Method of the Year 2022'

Powering a more complete reading of genomic information, Nature hails long-read sequencing as the omics-based method of the year.
Clinical Development

FDA Approves Merck-Developed KEYTRUDA for Non-Small Cell Lung Cancer Therapy

KEYTRUDA demonstrated a clinically meaningful improvement in disease-free survival in patients following surgical resection and platinum-based chemotherapy.
Spatial Analysis

The Future of Spatial Technology, Analysis, and Imaging

This Insight Article looks at the short and long-term predictions for spatial technological regulation, standardisation, and collaboration for the omics field.
Biomarker Discovery & Development

Bioassay Optimisation: How the Pandemic Reshaped International Standards for New Therapeutics

The global race to develop, trial, and distribute a vaccine for Covid-19 may have permanently accelerated the development of future therapeutics, including treatments for cancer.
Clinical Diagnostics

FDA Clears Genomic Profiling Test for Solid Tumours 

Regulatory approval for comprehensive genomic profiling test signifies “significant advancement in personalised cancer care.”
Genome Editing

FDA and NIH Sign Interagency Collaboration Agreement to Advance Proteogenomics Research

A memorandum of understanding has been reached between the U.S. Food and Drug Administration (FDA) and the National Cancer Institute (NCI) to provide a framework for solving complex problems in molecular characterisation and classification of tumours.
Clinical Development

FDA Commits to Increasing Diversity in Clinical Trials

The move follows steps announced by the EMA and the MHRA to ensure clinical trials are more reflective of patient populations.
Clinical Development

Predicting Parkinson’s Disease with Machine Learning

Understanding machine learning’s role in providing a biomarker for the neurological condition.
Diagnostic Development

Study Reveals Altered Spontaneous Brain Activity in People with Down Syndrome

A new study has revealed that using functional magnetic resonance techniques shows the differences in the spontaneous activity of the brain in people with Down syndrome compared to the general population.
Diagnostic Development

The Ethical Issues of Pre-Emptive Dementia Diagnosis

If you were at risk of developing Alzheimer’s disease, would you want to know?
Diagnostic Development

Low-Cost Method for Cancer Testing

The Heatrich-BS assay is a novel low-cost sequencing method for low-cost cancer testing.

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