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EMA/FDA

Gilead submits New Drug Application to FDA for the investigational single tablet regimen sofosbuvir/velpatasvir/voxilaprevir

If approved, SOF/VEL/VOX would be the first once-daily single tablet regimen available as a salvage therapy for patients infected with HCV genotype 1-6 who have failed prior treatment with DAA…

EMA warns of risk of hepatitis B re-activation with direct-acting antivirals for hepatitis C

Review of liver cancer risk not conclusive and further studies are needed EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that patients treated with medicines known as direct-acting antivirals for…

EMA: Workshop on adaptive pathways – discussion on development approach for medicines addressing unmet medical needs

Event to be broadcast live on 8 December The European Medicines Agency (EMA) in collaboration with the European Commission is organising a workshop on 8 December 2016 to gather the…

Kaisa Immonen elected as new co-chair of the European Medicines Agency’s Patients’ and Consumers’ Working Party

Co-chair elected for a three-year mandate The European Medicines Agency’s (EMA) Patients’ and Consumers’ Working Party (PCWP) has elected Kaisa Immonen as its new co-chair. Kaisa Immonen holds a Master…

Workshop: measuring the impact of pharmacovigilance activities

The event will be web-streamed on 5-6 December The European Medicines Agency (EMA) is organising a workshop to discuss methods to measure the impact of pharmacovigilance activities on patient safety.…

Workshop: towards new treatments for TB

The event will be broadcast on 25 November 2016 The European Medicines Agency (EMA) is organising a workshop on the development of new medicines to treat tuberculosis (TB). The event…

EMA: Revising the guideline on first-in-human clinical trials

Changes are open for comments until end of February 2017 The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union (EU),…

Dynavax says FDA rejects its hepatitis B vaccine

The U.S. Food and Drug Administration rejected Dynavax Technologies Corp's marketing application for its hepatitis B vaccine, Heplisav-B, for the second time in three years, sending the company's shares tumbling…

CHMP adopts positive opinion for Vemlidy for the treatment of hepatitis B

European CHMP adopts positive opinion for Gilead’s Vemlidy® (tenofovir alafenamide, TAF) for the treatment of chronic hepatitis B virus infection Vemlidy demonstrated similar efficacy with improvements in renal and bone…

Brochure: The European regulatory system for medicines

The European Medicines Agency developed a brochure on the European regulatory system for medicines. The booklet explains how the European regulatory system for medicines operates. It describes how medicines are authorized…