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1 July 2014 | By The European Medicines Agency
The European Medicines Agency’s Committee for Advanced Therapies has revised a reflection paper on the classification of advanced-therapy medicinal products to reflect the current thinking of the committee on how ATMPs should be classified...
30 June 2014 | By Merck
Merck announced the European Medicines Agency has accepted for review a Marketing Authorization Application for pembrolizumab (MK-3475)...
19 June 2014 | By Sanofi
Sanofi announced that, in a pooled analysis, investigational therapy Toujeo® (insulin glargine [rDNA origin] injection, 300 U/mL) consistently showed significantly fewer low blood sugar events (hypoglycemia)...
17 June 2014 | By AbbVie
AbbVie announced that the Marketing Authorization Applications for its investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 hepatitis C virus infection have been validated and are under accelerated assessment by the European Medicines Agency...
5 June 2014 | By The European Medicines Agency
European regulatory authorities have finalised their assessment of reported non-compliance with Good Manufacturing Practice at Ranbaxy Laboratories’ manufacturing site...
4 June 2014 | By The European Medicines Agency
The European Medicines Agency has published a revised guideline on the acceptability of names for human medicines processed through the centralised procedure...
30 May 2014 | By Biogen Idec
Biogen Idec received a positive recommendation from the Committee for Medicinal Products for Human Use of the European Medicines Agency for the marketing authorisation of PLEGRIDY...
29 May 2014 | By The European Medicines Agency
The European Medicines Agency welcomes the publication of the Clinical Trials Regulation in the Official Journal of the European Union...
19 May 2014 | By The European Medicines Agency
The European Medicines Agency’s Committee for Advanced Therapies and the German Society for Transfusion Medicine and Immunohaematology in collaboration with the German Stem Cell Network are organising a workshop to strengthen dialogue...
14 May 2014 | By The European Medicines Agency
The European Commission and the US Department of Health and Human Services have published a progress report of the Transatlantic Taskforce on Antimicrobial Resistance...
8 May 2014 | By AbbVie
AbbVie submitted marketing authorization applications to the European Medicines Agency seeking approval for the company's investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus infection...
2 May 2014 | By The European Medicines Agency
The European Medicines Agency has presented the European Commission with its first report on the tasks it undertook during the first year of application of the EU’s new pharmacovigilance legislation...
29 April 2014 | By The European Medicines Agency
In 2013, EudraVigilance received more than one million post-marketing expedited adverse-drug-reaction reports...
17 April 2014 | By The European Medicines Agency
The European Medicines Agency has been informed that vials of the cancer medicine Herceptin (trastuzumab), thought to have been stolen in Italy, including from hospitals, have been tampered with and re-introduced under false credentials into the supply chain in some countries...
11 April 2014 | By The European Medicines Agency
The Pharmacovigilance Risk Assessment Committee gave a recommendation on one safety review and started four new safety reviews at its April meeting...
