European Medicines Agency [to 28 May 2016]
http://www.ema.europa.eu/

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27/05/2016
Two new combination therapies against chronic hepatitis C
Direct-acting antivirals Epclusa and Zepatier recommended for approval
The European Medicines Agency (EMA) has recommended the granting of marketing authorisations in the European Union (EU) for two new combination therapies against chronic (long-term) hepatitis C virus (HCV) infection, Epclusa (sofosbuvir/velpatasvir) and Zepatier (grazoprevir/elbasvir).

HCV infection is a major European public health challenge. It affects between 0.4% and 3.5% of the population in different EU Member States and is the most common single cause of liver transplantation in the region.

Epclusa and Zepatier belong to a new generation of medicines for chronic HCV infection, direct-acting antivirals, that give high rates of cure of HCV infection and that have, in the past few years, reshaped the way this disease is treated. These medicines block the action of proteins which are essential for viral replication. Epclusa targets the proteins NS5B and NS5A, while Zepatier targets the proteins NS3/4A and NS5A…

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27/05/2016
Improving safety of first-in-human clinical trials
EMA starts EU-wide reflection on necessary changes to best practices
The European Medicines Agency (EMA) has started a review of the guidelines that describe first-in-human clinical trials and the data needed to enable their appropriate design and allow initiation. This is being done in cooperation with the European Commission and the Member States of the European Union (EU).

The review will identify which areas may need to be revised in the light of the tragic incident which took place during a Phase I first-in-human clincial trial in Rennes, France, in January 2016. The trial led to the death of one participant and hospitalisation of five others…