Remove 2016 Remove Drug Development Remove Pharmacokinetics
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The rising impact of biomarkers in early clinical development

Drug Target Review

In a recent survey conducted by ICON, Plc, biomarker selection was identified by 35 percent of respondents as a top challenge among drug developers for phase I trials, second only to navigating regulatory compliance (- 38 percent). Silver Spring (MD): Food and Drug Administration (US); 2016-. Bagyinszky E, et al.

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Navigating Regulatory Hurdles in Drug Development

DrugBank

Drug development is a complex and highly regulated process. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global counterparts, set rigorous standards to ensure that drugs are safe, effective, and high-quality. Regulatory agencies, such as the U.S.

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Looking beyond traditional oncogenic pathways to break cancer resistance

Drug Target Review

However, this will not be straightforward, given that non-oncogene resistance is driven by complex transcriptional networks, and the key drivers that determine how these mechanisms could be targets for drug development remain elusive. An inhibitor of KDM5 demethylases reduces survival of drug-tolerant cancer cells.

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Microbiotica: transforming medicine with microbiome magic

Drug Target Review

Microbiotica was spun-out of Trevor Lawley’s lab at the Sanger Institute in late 2016. The Lawley Lab team had pioneered culturing of the human gut microbiota and had developed new analytical approaches for efficient microbiome profiling.

Treatment 122
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ATICAPRANT

New Drug Approvals

4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 12] Positron emission tomography imaging revealed that brain KORs were almost completely saturated by the drug 2.5 February 2016). nM vs. 24.0

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Dupixent® (dupilumab) pivotal trial meets all primary and secondary endpoints.

The Pharma Data

In 2016, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for Dupixent for the treatment of severe atopic dermatitis (in children aged 6 months to 11 years of age). Detailed results from this trial will be presented at a future medical meeting, and data will be submitted to regulatory authorities.

Trials 52
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Analysis Life Sciences Thank You Workshop addresses oncology dose optimization across full span of development

Agency IQ

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

Science 40