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Goodwin

European Commission Approves Moderna’s Updated COVID-19 Vaccine

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On July 30, 2025, Moderna announced that the European Commission (EC) granted marketing authorization for the updated formulation of Moderna’s COVID-19 vaccine Spikevax®.  The updated vaccine targets the LP.8.1 variant of...more

Hogan Lovells

The European Commission tackles shortages of critical medicines through the Critical Medicines Act

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On Tuesday 11 March 2025, the European Commission published a legislative proposal for a Critical Medicines Act. The objective of this Act is to ensure stable supply and continuous availability of critical medicinal products,...more

Hogan Lovells

COVID-19- European Commission's recommendation on conformity assessment and market surveillance procedures

Hogan Lovells on

On 16 March 2020, the European Commission published Recommendation (EU) 2020/403 of 13 March on conformity assessment and market surveillance procedures within the context of the COVID-19 threat. The objective of the...more

Hogan Lovells

EDPB Advises on Lawful Grounds for Processing Personal Data in Clinical Trials

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With the coming into effect of the General Data Protection Regulation (GDPR), those conducting clinical trials in the EU face a complex set of rules ranging from lawful grounds for processing and transparency to restrictions...more

Hogan Lovells

European Commission invites targeted stakeholders for consultation on duplicate marketing authorisations for biological medicinal...

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The European Commission is seeking consultation on proposed clarifications for handling duplicate marketing authorisations from stakeholders....more

Bergeson & Campbell, P.C.

SCENIHR Identifies Use of Nanomaterials for Medical Imaging and Drug Delivery and Graphene Nanomaterials as Emerging Issues

On April 9, 2015, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) posted a Position Statement on emerging and newly identified health risks to be drawn to the...more

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