Eu Alert - Life Sciences

This newsletter provides a selection of opinions and analysis from our EU legal experts on interesting policy developments, recent case law and new regulatory directions of major industry practices. It is released biweekly and covers areas such as: Competition Law, Sanctions, Trade, Energy, Finance, EU funds, Data IP and Privacy, Life Sciences, Transport and Court of Justice of the European Union news.

The aim is to provide an up–to–date tool for quick and easy consultation on the most current and important topics at EU level.


EUROPEAN COMMISSION (EC)

The European Commission authorizes the first-ever vaccine against Chikungunya virus (28.06.2024) – The European Commission has authorised the first-ever vaccine against Chikungunya virus – a disease transmitted by infected mosquitoes. The EU authorisation of the Chikungunya vaccine is intended for adults over 18 years of age. It was unanimously endorsed by Member States following a stringent assessment by the European Medicines Agency (EMA). It is up to national authorities in each Member State to decide who will have access to the vaccine, taking into account the national situation and risk status.


EUROPEAN MEDICINES AGENCY (EMA)

The European Medicines Agency recommends Winrevair to treat adult patients with pulmonary arterial hypertension (28.06.2024) – The European Medicines Agency’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union (EU) for Winrevair (sotatercept) to treat adult patients with pulmonary arterial hypertension (PAH), in combination with other specific PAH therapies, to improve exercise capacity The opinion will be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation.

The European Medicines Agency recommends Eurneffyo for emergency treatment against allergic reactions (28.06.2024) – The European Medicines Agency’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Eurneffy (epinephrine), the first medicine to be taken through the nose for the emergency treatment of allergic reactions (anaphylaxis).The opinion will be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation.

The European Medicines Agency recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna (28.06.2024) – The European Medicines Agency has concluded its review of the medicine Ocaliva (obeticholic acid) and has recommended that the medicine’s marketing authorisation be revoked, because its benefits are no longer considered to outweigh its risks. Ocaliva is used to treat adults with primary biliary cholangitis (PBC), an autoimmune condition that causes gradual destruction of the bile ducts in the liver, which can lead to liver failure and increase the risk of liver cancer.

The European Medicines Agency recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna (28.06.2024) – The European Medicines Agency has recommended not renewing the conditional marketing authorisation for Translarna (ataluren), a medicine for treating patients with Duchenne muscular dystrophy. Translarna is used in patients whose disease is caused by a type of genetic defect called a ‘nonsense mutation’ in the dystrophin gene and who are able to walk.

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