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Biomarkers

 

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BMS Phase II study in non-alcoholic steatohepatitis a success 

24 April 2017 | By Niamh Marriott, Junior Editor

BMS-986036 is a pegylated analogue of human fibroblast growth factor 21, a key regulator of metabolism. In preclinical models of non-alcoholic steatohepatitis (NASH), BMS-986036 improved steatosis, inflammation, hepatocyte ballooning, and fibrosis.

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FDA approves Roche’s immunotherapy assay to support treatment decisions in lung cancer

31 October 2016 | By Niamh Louise Marriott, Digital Content Producer

The US Food and Drug Administration (FDA) has approved Roche’s PD-L1 assay as a diagnostic to identify PD-L1 expression levels in patients considering treatment with Tecentriq (atezolizumab) for previously treated metastatic non-small cell lung cancer (NSCLC). The PD-L1 (SP142) assay is also indicated to identify patients with urothelial cancer (UC)…

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Biomarker breakthrough could improve Parkinson’s treatment

16 August 2016 | By University of Florida

Scientists have found that using magnetic resonance imaging reveals areas where Parkinson’s disease causes progressive decline in brain activity, a biomarker discovery which will help to evaluate new experimental treatments to slow or stop the disease’s progression...

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MIQE compliance in expression profiling and clinical biomarker discovery

6 January 2016 | By Irmgard Riedmaier, Melanie Spornraft, Benedikt Kirchner and Michael W. Pfaffl, Technical University of Munich

Molecular diagnostics and biomarker discovery are gaining increasing attraction in clinical research. This includes all fields of diagnostics, such as risk assessment, disease prognosis, treatment prediction and drug application success control. The detection of molecular clinical biomarkers is very widespread and can be developed on various molecular levels, like the…

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Imaging for decision-making in drug discovery and early development

23 December 2014 | By Paul McCracken & Stephen Krause

The cost of drug discovery and development, depending upon the size of a given company, has been estimated upwards of $5 billion. Hay et al. recently published a review of clinical development success rates showing only a 10.4% likelihood of regulatory approval of all drugs entering Phase I, 64.5% of…

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Pharmaceutical proteomics: a journey from discovery and characterisation of targets to development of high-throughput assays

15 December 2013 | By Joerg Reinders, Institute of Functional Genomics, University of Regensburg

Proteomics has evolved during the last few years from a time-intensive, cost-intensive and hard-to-reproduce technique in basic research to a versatile and reliable tool in various areas of pharmaceutical research. The exploding progress in mass-spectrometry-compatible protein and peptide-separation methods led to the development of new approaches particularly suited for monitoring…