Tag Archives: EMA
By Guest Blogger | Published: August 1, 2014
As Europe departs for its annual holiday—sacrosanct, even amid the continuing economic woes, the multiple crises in the Middle East, and the dark mysteries of Russia’s intentions in its former satellites—the question remains unresolved as to what to expect from the new European Parliament in the new term. Philip Ward considers the options in this […]
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.