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Whereas the existing ICH quality documents covering impurities in new drug substances (ICH Q3A(R2)) and drug products (ICH Q3B (R2)) provide a framework for the qualification and control of most commonly encountered impurities and degradants, it is recognised that lower thresholds may be appropriate if the impurity is unusually toxic…
14 February 2014 | By GlaxoSmithKline
GlaxoSmithKline announced the start of a Phase III study to evaluate the efficacy and safety of mepolizumab, an investigational IL-5 antagonist, in patients with Eosinophilic Granulomatosis with Polyangiitis...
3 February 2014 | By GlaxoSmithKline
GlaxoSmithKline plc announced that the FDA has granted Breakthrough Therapy designation for Promacta®/Revolade® (eltrombopag) for the treatment of cytopenias...
13 January 2014 | By GlaxoSmithKline
This transfer of rights represents the termination of the collaboration agreement between GSK and Prosensa executed in 2009....
2 January 2014 | By GlaxoSmithKline
GSK became the first company to launch an online system enabling external researchers to request access to the detailed data that sit behind its clinical trial results...
18 December 2013 | By Merck
“Collaborations like this are central to Merck’s strategy to evaluate the potential of MK-3475 for the treatment of cancer..."
17 December 2013 | By GlaxoSmithKline
GSK sets out plans to evolve the way it sells and markets its products to healthcare professionals...
16 December 2013 | By GlaxoSmithKline
GSK intends to keep the Company publicly-listed...
Specifications (test and acceptance criteria) for active pharmaceutical ingredients (APIs) and drug products are defined in ICH Q6A. It ‘establishes a set of criteria to which a drug substance or drug product should conform to be considered acceptable for its intended use.’ The guidance is sub-divided into universal tests applicable…
11 December 2013 | By GlaxoSmithKline
Manufacturing sites in Ware, Hertfordshire and Worthing, Sussex will be upgraded with new state-of-the-art equipment...
5 December 2013 | By GlaxoSmithKline
GlaxoSmithKline plc announced the formation of the Oncology Clinical and Translational Consortium...
28 November 2013 | By GlaxoSmithKline
GSK announced that the European Medicines Agency's Committee for Medicinal Products for Human Use is recommending marketing authorisation for a two-dose schedule in 9-14 year old girls for its cervical cancer vaccine, Cervarix™...
25 November 2013 | By GlaxoSmithKline
The U.S. Food and Drug Administration has eased restrictions on patient access to Avandia (rosiglitazone)...
25 November 2013 | By GlaxoSmithKline
GlaxoSmithKline plc announced that the FDA has approved its pandemic Influenza A Virus Monovalent Vaccine...
21 November 2013 | By GlaxoSmithKline
“We welcome the CHMP’s positive opinion on dolutegravir – it puts us a step closer to offering this new treatment option to people across Europe who are living with HIV...”
