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
In the past few weeks, the European Commission provided marketing authorization for biosimilars of denosumab and omalizumab, as well as an ophthalmic formulation of bevacizumab....more
In April 2023, we published an alert in relation to two European Commission legislative proposals: new Regulation 2023/0131 and new Directive 2023/0132, to replace the current EU regulatory framework for all medicines...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
On 24 October 2023, the European Commission (EC) adopted a set of actions in order to prevent and mitigate critical medicine shortages in the European Union (EU) this winter and beyond....more
We recently published an alert in relation to the European Commission’s legislative proposals to replace the current EU regulatory framework for all medicines (including those for rare diseases and for children). One of the...more
On 26 April 2023, the European Commission published two legislative proposals - a new Regulation 2023/0131 and a new Directive 2023/0132 - to replace the current EU regulatory framework for all medicines (including those for...more
Yesterday, the European Commission published two legislative proposals concerning the regulation of medicinal products in the European Union. The proposals seek to consolidate existing legislation into two instruments, a...more
This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion. ...more
Teva announced today that the European Commission has granted marketing authorization for RANIVISIO, a biosimilar ranibizumab, for the treatment of age-related macular degeneration (AMD). Teva entered into a strategic...more
The EU Commission opened this afternoon the public consultation on the EU general pharmaceuticals legislation on medicines for human use. This initiative is part of the EU Pharmaceutical Strategy for Europe and calls on...more
On 23 September 2020, in a landmark case, Medac v Commission, the trial-level General Court (“GC”) of the European Union (“EU”) annulled the decision of the European Commission (“EU Commission”) that had withdrawn the orphan...more
On 10 April 2020, the European Commission, the EMA and the European medicines regulatory network published a notice providing guidance to stakeholders regarding regulatory expectations for medicinal products for human use...more
Below are a few biosimilar-related updates from the past week. Bio-Thera Solutions announced that in a Phase III clinical trial of BAT1706 (bevacizumab), BAT1706 met its primary endpoint, demonstrating “equivalence in...more
On April 27, 2017, the European Medicines Agency ("EMA") held a meeting with the heads of the National Competent Authorities ("NCAs") of the European Union ("EU")/European Economic Area ("EEA") Member States to discuss the...more
The European Commission (EC) has published a report (Report) recommending improvements in the summary of product characteristics (SmPC) and the Patient Information Leaflet (PIL) of medicinal products for human use. The report...more