Fierce Competition Podcast | Takeaways From the Illumina-Grail Merger Challenge Saga
The EU Corporate Sustainability Due Diligence Directive
The Informed Board Podcast | Will the EU’s Focus on Foreign Subsidies Make It More Difficult To Acquire European Businesses?
EU & UK Competition Law & Public Interest: Best Practices & New Challenges ahead
Nota Bene Episode 135: Europe Q3 Check In: Brexit, Data Protection, and Block Exemption Regulations with Oliver Heinisch
NGE On Demand: Personal Data Protection Travels: The New Standard Contractual Clause with John Koenigsknecht and David Wheeler
Nota Bene Episode 123: Europe Q2 Check In - Brexit Updates and Antitrust Laws in the Digital Economy with Oliver Heinisch
Nota Bene Episode 112: How Europe is Filling Enforcement Gaps for Digital Gatekeepers with Robert Klotz and Ciara Barbu-O’Connor
Nota Bene Episode 106: The Corporate Investor Movement Toward Environmental, Social, and Governmental Policies with Allison Troianos and Ariel Yehezkel
Nota Bene Episode 102: Examining European Union State Aid in the Face of COVID and Brexit with Jacques Derenne and Robert Klotz
What's Next after the Schrems II Decision of ECJ
Compliance Perspectives: The End of the Privacy Shield
Nota Bene Episode 89: European Q3 Check In - Merger Clearance and Data Protection Court Rulings and Brexit Updates with Oliver Heinisch
Podcast: ESMA Report: Undue Pressure on Companies
Nota Bene Episode 65: European Check In: Environmental Protection, Privacy Regulations, Digital Market Definition, and Brexit with Oliver Heinisch
Nota Bene Episode 55: Updates on the European Commission and Brexit with Isabelle Rahman and Oliver Heinisch
Jones Day Talks: EU's New Foreign Direct Investment Regulations Eye Specific Sectors
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
On 31 January 2025 the Clinical Trials Regulation will become fully applicable to all ongoing clinical trials with medicinal products in the EU. All clinical trials that have been authorized under the Clinical Trials...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
This regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression on against Ukraine, and cyber threats. It does not purport to provide...more
This regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression on against Ukraine, and cyber threats. ...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
Meta description: Learn more about possible ways to leverage the EU’s REACH and EMA regulations for product stewardship and reaching sustainability goals. Product Stewardship as a Leverage for Sustainability Goals...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
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
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
The European Commission has announced that the Clinical Trials Regulation, already enacted in 2014, will take effect on 31 January 2022....more
LATEST KEY DEVELOPMENTS Competition & State Aid • Portugal is first Member State to officially deliver Recovery and Resilience Plan to European Commission • EU Single Resolution Board responds to European...more
LATEST KEY DEVELOPMENTS - Competition & State Aid • European Commission issues Comfort letter on Cooperation at a Matchmaking Event – Towards COVID19 vaccines upscale production • European Commission publishes...more
LATEST KEY DEVELOPMENTS - Competition & State Aid • Commissioner McGuinness addresses EU’s bank crisis management and deposit insurance framework, including COVID-19 crisis and State aid concerns • EU approves...more
LATEST KEY DEVELOPMENTS Competition & State Aid • European Commission pursues Fit for Future Platform to simplify EU law, including in the area of State aid, particularly in response to the pandemic • EU approves new...more
LATEST KEY DEVELOPMENTS - Competition & State Aid • EU approves new and amended Member State measures to support the economy • Executive Vice-President and Competition Commissioner Vestager speech on the future of State...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
The European Commission (Commission) has released a Staff Working Document concerning its joint evaluation of the Orphan Regulation and the Paediatric Regulation (collectively, the Regulations) (Joint Evaluation) and an...more
In March, most European Union (‘EU’) countries ordered some form of lockdown and adopted many national measures to address or prevent issues raised by COVID-19. The health crisis pushed national authorities to focus on their...more