SkadBytes Podcast | Tech’s Shifting Landscape: Five Trends Shaping the Conversation
Daily Compliance News: April 25, 2025, The Trouble in Travel Edition
Daily Compliance News: April 24, 2025, The Made in Malaysia Edition
Regulatory Ramblings: Episode 64 – Building Inclusion Through Sustainable Leadership / The EU Omnibus Proposal with Janet Ledger and Dr. Inna Amesheva
Fierce Competition Podcast | Below-Threshold Mergers: Global Antitrust Scrutiny
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
The first half of 2025 has seen an acceleration of M&A activity, including large-scale life sciences transactions, such as Merck’s $3.9 billion acquisition of SpringWorks, Sanofi’s $9.5 billion acquisition of Blueprint...more
In July 2025, the European Competition Commission imposed a EUR 489,000 fine on Alchem International Pvt. Ltd. and its Hong Kong subsidiary for their involvement in a pharmaceutical cartel involving the active ingredient used...more
On July 15, 2025, Biocon Biologics, a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., announced that the FDA has approved KIRSTY (insulin aspart-xjhz injection), 100 units/mL, as the first and...more
On July 27, 2025, President Trump announced that the U.S. and European Union (“EU”) have reached a trade deal. Pursuant to the Fact Sheet released by the White House on July 28th, the U.S. will impose a 15% tariff on all EU...more
On 4 July 2025, the EC fined Alchem and its subsidiary EUR 489,000 for their role in a long-running cartel concerning the active pharmaceutical ingredient SNBB, used in the production of Buscopan and its generics. This marks...more
Dealmaking in Europe’s life sciences sector has been relatively muted in recent years, but the first half of 2025 has shown signs of strength as companies respond to the stark realities of an aging population - Earlier this...more
OVERVIEW - The UK Competition and Markets Authority (“CMA”) has recently published a decision accepting commitments from Vifor Pharma (“Vifor”). This brings to a close an unprecedented abuse of dominance investigation...more
This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more
This newsletter is a summary of the antitrust developments we think are most interesting to your business. Eliana Paredis (counsel based in Brussels) is our editor this month. She has selected: - European Commission kicks...more
On October 31, 2024, the European Commission (the Commission) delivered its long-awaited decision in the Teva Copaxone case (which was published on April 8, 2025). Teva, a global pharmaceutical company, was fined EUR 462.6...more
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
The European Commission has revised the Urban Wastewater Treatment Directive (“UWWTD”), which is instrumental in mitigating urban wastewater pollution across EU. This revision, prompted by emerging environmental challenges,...more
On February 23, 2025, Celltrion announced that the European Commission (“EC”) approved its tocilizumab biosimilar, AVTOZMA® (CT-P47), referencing Roche’s ROACTEMRA®....more
Antitrust authorities continue to make use of powers to scrutinize deals falling below merger control filing thresholds. Many that don’t have that ability, want it. The European Commission (EC) remains the frontrunner in...more
The last year (and particularly the last few months) of the Biden Administration brought a flurry of activity from the Federal Trade Commission (FTC) in the life sciences space, continuing a yearslong pattern of close...more
As we have seen in the first article of our series, trademarks play an important role in the protection of your pharmaceutical and life science products and can add significant value. But to understand the benefits but also...more
On November 18, 2024, Samsung Bioepis announced that the European Commission (EC) has approved its aflibercept biosimilar, OPUVIZ. ...more
On October 31, 2024, the European Commission (EC) fined Teva 462.6 million euros (US$503 million) for abusing its dominant position to delay competition to Copaxone (glatiramer acetate), its blockbuster multiple sclerosis...more
As we previously reported, this August the European Commission granted approval for Celltrion’s STELARA biosimilar, STEQEYMA. Earlier this month, Celltrion launched STEQEYMA in both Germany and the Netherlands....more
On October 31, 2024, the European Commission (EC) fined Teva Pharmaceutical Industries Limited and Teva Pharmaceuticals Europe BV (Teva) EUR462.6 million for abusing a dominant position in several EU Member States on the...more
To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more
The "European Antitrust Bimonthly Bulletin” breaks down the major antitrust developments in Europe during the past two months into concise and actionable takeaways. ...more
On July 22, 2024, the European Commission (EC) accepted commitments proposed by Vifor Pharmaceuticals to address disparagement concerns under Article 102 TFEU. This is the EC’s first pure disparagement case and its second...more
Court Orders Delisting of Patents from Orange Book and Denies Motion to Dismiss Antitrust Counterclaims for Improper Orange Book Listings. On June 10, Judge Stanley Chesler of the District of New Jersey entered judgment on...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more