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Amgen submits sBLA for Blincyto to the FDA

2 March 2016 | By Victoria White

The sBLA includes new data supporting the treatment of paediatric and adolescent patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL)...

Foreword: The evolving pharmacopoeia

29 February 2016 | By

Globalisation has facilitated greater international harmonisation and standardisation of quality standards, which in turn has impacted on pharmacopoeias1. Historically, general chapters were developed based on input from local regions with little concern for global consequences. This often led to the development of similar, but unidentical tests, for example, Residue on…

Four trends that will transform healthcare in Europe in 2016

29 February 2016 | By Warren Hochfeld, Jenna Riffell and Neil Levinson from Kaiser Associates

With 2015 giving some hints of what is to come, the Kaiser Associates European Healthcare team are predicting another year of big disruptions, transformations and innovations as the healthcare industry continues to overhaul outmoded business models...

The application of skip testing to drug substance manufacture

29 February 2016 | By Phil Borman, Simon Bate and Keith Freebairn, GlaxoSmithKline

Skip testing is a process employed to reduce the analytical drugs testing burden and lends itself to processes with high frequency batch production. Rather than test all batches within a given interval, pre-selected batches are assessed and the other batches ‘skipped’. This reduction is justified as it is shown that…

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