News & Analysis as of

Life Sciences Member State European Commission

Goodwin

In a Landmark Judgment, Top European Court Curbs European Commission’s Ability to Review “Killer Acquisitions”

Goodwin on

On 3 September 2024, the European Court of Justice (ECJ) ruled that the European Commission (Commission) cannot encourage or accept referrals for below-threshold deals from national competition authorities if those...more

Skadden, Arps, Slate, Meagher & Flom LLP

Antitrust in Life Sciences: A Dialogue With Anna Vernet

On March 26, 2024, Skadden hosted a discussion on key developments in antitrust enforcement in the pharmaceuticals and life sciences sectors. ...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - November 2023

WilmerHale on

European Commission Orders Unprecedented Unwinding Of Illumina’s Acquisition of GRAIL. For the first time, the European Commission has ordered reversal of a consummated transaction, Illumina Inc.’s 2021 acquisition of GRAIL...more

Goodwin

The European Commission Proposes First Major Overhaul of the EU Medicines Regulatory Framework in 20 Years: Regulatory Data...

Goodwin on

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

Cooley LLP

European Commission Publishes Proposals to Revise Current EU Pharmaceutical Legislative Framework

Cooley LLP on

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

Hogan Lovells

Espacio Europeo de Datos Sanitarios: una revolución para la historias clínicas electrónicas

Hogan Lovells on

Los prestadores de asistencia sanitaria almacenan y utilizan historias clínicas electrónicas ("HCE") en el contexto de la prestación de dichos servicios sanitarios. Sin embargo, la configuración de dichas HCE por parte de los...more

WilmerHale

The European Commission publishes its proposal on the European Health Data Space (EHDS)

WilmerHale on

On May 3, 2022, the European Commission published a proposal for a Regulation on the European Health Data Space (EHDS) (“EHDS Regulation”, or “Proposal”). With the Proposal, the European Commission aims to make significant...more

King & Spalding

Europe - Between The EU Clinical Trials Regulation And The UK Guideline On Clinical Trials

King & Spalding on

Last week the Regulation on Clinical Trials (“CTR”) finally became effective in the European Union (“EU”) and replaced the prior Clinical Trials Directive 2001/20 (“CTD”). The CTR was adopted in 2014 and was meant to enter...more

Hogan Lovells

The new Clinical Trials Regulation – what you need to know now - Episode 1: Transitional period and timeline

Hogan Lovells on

With this series we provide insights on what you need to know now about the new EU Clinical Trials Regulation (“CT Regulation”). Episode 1: Transitional period and timeline Do you wonder when you need to apply the new rules...more

Hogan Lovells

New Brexit Q&A provides several examples in relation to the “placing on the EU market” of products including medical devices

Hogan Lovells on

On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more

Jones Day

Update on Recommendations and Initiatives of EU Regulators Ahead of Brexit

Jones Day on

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

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