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Microbiology: In-Depth Focus 2016
In this Microbiology In-Depth Focus: Risk-based microbiological testing; Improving microbiological assurance for bioburden testing; Microbiology Roundtable...
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GlaxoSmithKline (GSK)
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MenABCWY set to revolutionise the meningococcal vaccine market
29 June 2016 | By Victoria White, Digital Content Producer
GlobalData says MenABCWY has the potential to significantly change the approach used to prevent meningococcal disease...
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Greater response with GSK’s Benlysta vs placebo in SLE study
8 June 2016 | By Victoria White, Digital Content Producer
Patients with SLE experienced a significantly greater response to treatment with Benlysta administered via subcutaneous injection compared to placebo...
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Sirukumab meets both co-primary endpoints in rheumatoid arthritis study
8 June 2016 | By Victoria White, Digital Content Producer
The SIRROUND-D study met both co-primary endpoints in evaluating treatment with sirukumab in adult patients with active rheumatoid arthritis...
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From HIV to oncology: widening access through flexible IP
28 April 2016 | By Jon Pender, VP Government Affairs, GSK
Jon Pender, GSK, discusses how a flexible and thoughtful approach to IP can help get medicines to the poorest and hardest-to-reach patients around the world...
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GSK adopts groundbreaking IP approach to expand access to its medicines
31 March 2016 | By Victoria White
Sir Andrew Witty has set out a series of steps designed to help bring innovative GSK medicines to more people living in the world’s poorest countries...
webinar
Integrated, predictive and collaborative workflows in biologics discovery
23 March 2016 | By Dassault Systèmes BIOVIA & GlaxoSmithKline
As well as delving into secure data sharing, the speakers from BIOVIA and GSK will discuss implementing the BIOVIA Biological Registration solution. The speakers will highlight the importance of effective IP protection and improved decision-making through an integrated and collaborative platform...
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GSK presents data on of Nucala in asthma patients stratified by eosinophil levels
The post-hoc analysis confirms the predictive nature of the relationship between baseline blood eosinophil counts and efficacy outcomes in patients treated with mepolizumab...
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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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Dissolution testing in the modern world
Historically, dissolution testing has been used primarily as a quality control (QC) test for solid oral drug products1. Indeed, it is the only QC test which provides a measure of the quantitative release rate of the drug from the pharmaceutical product. More recently, the test has been proposed in lieu…
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Industrial pharmaceutical sieves for powders at GSK
GlaxoSmithKline is improving process efficiency in the production of pharmaceutical powders at its “centre of excellence” plant in Dartford, Kent, by investing in nine new industrial pharmaceutical sieves fitted with the Vibrasonic® Deblinding System from Russell Finex...
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PAT In-Depth Focus 2015
Featuring an overview of process analytical control; Beyond API monitoring: in-line Raman spectroscopy for process control; Monitoring, understanding and assessing pharmaceutical process and product quality; and a PAT roundtable...
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Phase III study of sirukumab in giant cell arteritis starts
27 November 2015 | By Victoria White
Sirukumab is an investigational human anti-IL-6 monoclonal antibody that selectively binds with high affinity to the IL-6 cytokine...
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Foreword: Importation testing: an unnecessary burden on industry?
One of the principle objectives of the Internal Conference on Harmonisation (ICH) initiatives was to introduce harmonised approaches, prevent duplication and eliminate wasteful and unnecessary testing. Although good progress was made initially, there was evidence that certain countries, regions and trans-national organisations were unhappy with some of the proposed harmonised…
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Positive head-to-head results for GSK’s umeclidinium in COPD
21 October 2015 | By Victoria White
The results come from two head-to-head studies directly comparing the efficacy and safety of umeclidinium to two available bronchodilator treatments...
