BC Innovations | Feb 15, 2019
Tools & Techniques

Heartening predictors in diabetes

New biomarkers of cardiovascular risk could relieve a decade-old bottleneck for diabetes drug development, but validating them will require companies to invest in strategic trial designs, and public and private stakeholders to pool thinking. As...
BC Innovations | Jun 29, 2018
Tools & Techniques

QT replacement plan

FDA has completed validation of a preclinical assay system that could replace clinical QT testing, a move it hopes will lower development costs and reduce false alarms of arrhythmia risk. The question for drug developers...
BioCentury | Mar 31, 2017
Regulation

Stuck in the MIDD-le

An FDA meeting to discuss evidentiary standards for model-informed drug development revealed concerns that rigid regulatory requirements could undermine the utility of the approach. Rather than specifying requirements for qualifying models as EMA has done,...
BC Week In Review | May 16, 2016
Company News

International Centre for Genetic Engineering and Biotechnology, Sun Pharmaceutical deal

ICGEB granted Sun exclusive, worldwide rights to develop and commercialize Cissampelos pariera, a plant-derived medicinal product, to treat dengue fever. ICGEB will establish assay systems for development of the product. Sun will fund development, and...
BC Innovations | Mar 5, 2015
Strategy

Cardio reboot

A two-year-old FDA initiative is progressing toward its goal of replacing clinical QT studies with preclinical assays that do a better job at predicting proarrhythmia side effects. The question is what impact replacing QT will...
BioCentury | Feb 20, 2006
Tools & Techniques

Hitting the kill switch

Most pain therapies are aimed at one of three targets - opioid receptors, COX-2 or sodium channels - but all have limitations in terms of efficacy and side effects. Thus, when scientists discovered the role of nerve...
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