EMA

Five additional countries to benefit from EU-US mutual recognition agreement for inspections

In November 2018, the US Food and Drug Administration (FDA) confirmed the capability of five additional EU Member States to carry out good manufacturing practice (GMP) inspections at a level equivalent to the United States (US). Belgium, Denmark, Finland and Latvia were included into the mutual recognition agreement between the European Union (EU) and the United States (US) on 16 November and Estonia on 28 November 2018.

New gene therapy for rare inherited disorder causing vision loss recommended for approval

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for the gene therapy Luxturna (voretigene neparvovec), for the treatment of adults and children suffering from inherited retinal dystrophy caused by RPE65 gene mutations, a rare genetic disorder which causes vision loss and usually leads to blindness.

First vaccine for prevention of dengue

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Dengvaxia (dengue tetravalent vaccine (live, attenuated)), for the prevention of dengue caused by dengue virus serotypes 1, 2, 3 and 4 in people who are between 9 and 45 years old, live in an endemic area and already had a prior dengue virus infection.

EMA launches new corporate website

The European Medicines Agency (EMA) has launched a new version of its corporate website. The website has a number of new features to improve user experience, including:

New medicine for the prevention of migraine

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Emgality (galcanezumab), a monoclonal antibody for the prevention of migraine. Emgality belongs to a new class of medicines that work by blocking the activity of calcitonin gene-related peptide (CGRP), a molecule that is involved in migraine attacks.

Improving understanding of biosimilars in the EU

The European Medicines Agency (EMA) and the European Commission have published additional information material on biosimilar medicines, as part of their ongoing collaboration to improve understanding of biosimilars across the European Union (EU). A biosimilar is biological medicine that is highly similar in all essential aspects to a 'reference' biological medicine already authorised.

Development of medicines for rare diseases

A disease is considered rare if fewer than five in 10,000 people have it. Around 30 million people in the European Union (EU) suffer from a debilitating rare disease, which means one in 17 people. Finding effective treatment for these rare diseases is a huge challenge.

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