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EMA/FDA

AbbVie submits to FDA its investigational pan-genotypic regimen of glecaprevir/pibrentasvir for the treatment of chronic hepatitis C

If approved, glecaprevir/pibrentasvir will provide an eight week once-daily, ribavirin-free treatment option for HCV patients without cirrhosis across all major genotypes AbbVie's investigational regimen was granted Breakthrough Therapy Designation by…

CHMP recommends extension of therapeutic indication for Tivicay

At its December meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended an extension of the existing therapeutic indication for Tivicay. Summary of opinion is…

EMA hosts workshop on adaptive pathways

Broad range of stakeholder questions addressed The European Medicines Agency (EMA) has hosted a workshop with stakeholders to discuss adaptive pathways, an approach to medicines development that aims to facilitate…

Trump is considering a radical to lead FDA. That’s dangerous for public health

Imagine being prescribed a medicine when neither your doctor nor the manufacturer has any clue whether it will actually work — because the government never required it to be tested for…

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…