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Personalised medicine, batch size of ONE, the new challenge to fill-finish?
Wenzel Novak PhD gives some considerations on container, environment, process and automation for small batch sizes in the downstream process of fill-finish…
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Biomarkers
news
FDA approves first cancer treatment for any solid tumor with a specific biomarker
24 May 2017 | By Niamh Marriott, Junior Editor
The US Food and Drug Administration granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker)...
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Roche receives FDA approval for bladder cancer biomarker assay
5 May 2017 | By Niamh Marriott, Junior Editor
The FDA has approved Roche’s biomarker assay as a complementary diagnostic to provide PD-L1 status for patients with urothelial carcinoma...
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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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GeNeuro initiates Phase 2a study in Australia to treat Type 1 Diabetes
19 April 2017 | By Niamh Marriott, Junior Editor
GeNeuro have started a Phase 2a clinical study in Australia with GNbAC1 in patients with Type 1 diabetes. GNbAC1 is a monoclonal antibody designed to...
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Biocartis and Merck partnership launch second liquid biopsy assay
15 March 2017 | By Niamh Marriott, Junior Editor
This collaboration is aimed at jointly developing and commercialising new liquid biopsy RAS biomarker tests for metastatic colorectal cancer (mCRC)...
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Dolomite Bio’s Single Cell RNA-Seq System accelerating cancer research
8 December 2016 | By Dolomite Bio
Researchers at The Institute of Cancer Research (ICR), London, are taking advantage of the single cell encapsulation capabilities of Dolomite Bio’s Single Cell RNA-Seq System to investigate resistance mechanisms in prostate cancer...
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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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First patient enrolled in IPF biomarker study of Ofev
30 June 2016 | By Victoria White, Digital Content Producer
INMARK is a study investigating the effect of Ofev (nintedanib) on changes in specific blood biomarkers in patients with idiopathic pulmonary fibrosis...
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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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AYOXXA and SERI to collaborate on protein biomarker detection
3 February 2015 | By AYOXXA Biosystems / SERI
AYOXXA and SERI will work together on validating the company’s multiplexing technology platform for protein biomarker detection, as part of an expanded collaboration for developing ophthalmic diagnostic tools...
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Your next clinical biomarker will be assayed by mass spectrometry….or not!
23 December 2014 | By Axel Ducret, Biochemist
This article will focus on some of the critical aspects of transition biomarkers discovered in classical (MS-based) proteomics workflows and on the challenges to be met before validated assays can become more routine in the clinical laboratory...
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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…
