Evidence still lacking for Ebola treatments, concludes European Medicines Agency Lack of evidence for seven investigational drugs being developed for the treatment of Ebola means it is impossible to make conclusions about their safety or efficacy.…
France, Germany, Belgium and Luxembourg suspend drug licences for some GVK Biosciences generics Four European countries have suspended the marketing authorisations for 25 generic medicines tested by GVK Biosciences at its plant in Hyderabad, India.…
EMA says flu vaccine is safe after deaths in ItalyThere is no evidence that Novartis’s Fluad is unsafe, the European Medicines Agency (EMA) says, after 13 deaths in Italy were reported as being associated with the influenza vaccine.…
Initial Fluad investigations find no manufacturing defectPreliminary investigations have found no manufacturing defect in the influenza vaccine Fluad, which has been linked to the deaths of 13 older people in Italy.…
Medicines regulator amends conflict of interest rules to ensure suitability of experts The European Medicines Agency has amended its policy on handling declarations of interest to ensure pharmaceutical experts are not unduly excluded.…
EllaOne to be available without prescriptionEllaOne (ulipristal acetate), an emergency contraceptive, is to be made available without a prescription from community pharmacies throughout the European Union.…
Pipeline November 2014 The latest approvals and positive opinions from the European Medicines Agency.…
Immune checkpoint inhibitors bring new hope to cancer patients PD-1 and PD-L1 inhibitors induce a higher response rate across a wider range of tumours than other immunotherapies.…
Forces driving the evolution of biologics into biosimilars and biobetters As demand for biologics increases, manufacturers are devising strategies to maximise their returns on investment and benefit patients.…
European Medicines Agency head steps down after “procedural error” Guido Rasi, the executive director of the European Medicines Agency (EMA), has been forced to step down after a “procedural error” in the process that appointed him to the position.…