Tag Archives: EMA
By Pharm Exec | Published: July 30, 2014
GSK announced that it has submitted a regulatory filing to the European Medicines Agency (EMA) for its malaria vaccine candidate, RTS,S. RTS,S is intended for use against the Plasmodium falciparum malaria parasite, which is most prevalent in sub-Saharan Africa (SSA). It is estimated that malaria accounts for approximately 90% of deaths in SSA, of which 77% occur […]
By Pharm Exec | Published: July 9, 2014
The European Medicines Agency (EMA) has postponed formal adoption of the policy on publication of clinical trial data. An EMA press statement said that “[f]urther clarifications on wording and practical arrangements will be discussed by Board members”, whose additional contributions will now be considered with a view to reaching final agreement at the Management Board meeting on 2 October. […]
By Guest Blogger | Published: July 8, 2014
By Leela Barham. Accessing the latest cancer drugs always seem to be controversial. Not just because of the money but also because of the complexities of accessing treatments during their development. This seems to be especially the case for young people with cancer, according to the UK’s Teenage Cancer Trust.
By Pharm Exec | Published: June 13, 2014
The European Medicine Agency’s Pharmacovigilance and Risk Assessment Committee (PRAC) has started a review to evaluate the cardiovascular risks with systemic ibuprofen medicines.
By Guest Blogger | Published: June 2, 2014
One of EMA’s key objectives this year is improvements in dealing with the “causes and impact of shortages of human medicines caused by GMP non-compliance and quality defects”. The European Directorate for the Quality of Medicines & Healthcare, which is responsible for the European Pharmacopoeia but also runs its own inspection operations, has been tightening […]