Tag Archives: EMA

The European Parliament’s New Term: What Can We Expect?

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 […]
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GSK Submits Malaria Vaccine Candidate for EMA Approval

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 […]
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EMA Delays Adoption of Policy on Publishing Trial Data

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. […]
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Industry Challenged: “Do More for Teenagers with Cancer”

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. 
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EMA to Review Safety of Ibuprofen Medicines

The European Medicine Agency’s Pharmacovigilance and Risk Assessment Committee (PRAC) has started a review to evaluate the cardiovascular risks with systemic ibuprofen medicines.
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