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FDA, EMA Seek Input on Companion Diagnostics, Genomic Biomarkers

Regulators in the U.S. and Europe have each posted requests for public comment on issues affecting the development of medicines by drug companies.

Rosetta Genomics and UC Davis Researchers to Develop and Validate microRNA Biomarker to Predict Response to Neoadjuvant Chemotherapy in Bladder Cancer

Rosetta Genomics, a leading developer and provider of microRNA-based molecular diagnostic tests, announces it has entered into a collaboration with the University of California, Davis (“UC Davis” or the “University”) to develop and validate a microRNA profile for muscle-invasive bladder cancer (MI-BC) that is predictive of patient response to neoadjuvant chemotherapy. The collaboration allows for UC Davis researchers to continue using Rosetta’s platforms and microRNAs to further discover new biomarkers and validate their results.

Imaging Biomarkers

Large pharma has been seeking new biomarkers for years – all part of their drug discovery process, but often only as an afterthought in the development process. That’s changed over recent years, but by-and-large the bulk of biomarker work remains in the hands of small- to medium-sized companies whose focused approach is more attuned to biomarkers being a major element of a final product.

ExonHit Presents Promising Data on Genomic Biomarkers in Alzheimer’s Disease Clinical Trials

ExonHit Therapeutics announced today that promising data regarding the use of blood-based genomic biomarkers in Alzheimer’s disease (AD) clinical trials were disclosed in two distinct oral presentations at the Third Conference of Clinical Trials on Alzheimer’s Disease (CTAD) from November 3rd to November 5th in Toulouse, France.