Our global network of life sciences experts will share their views and insights on the latest developments in the industry. They'll comment on and analyse topics including pharmaceuticals, digital health, medical devices, biotech, IP and life sciences regulatory issues around the world.
Articles: 1-10 of 30
EU Commission proposes much anticipated MDR and IVDR revision
European Union - December 17 2025 The EU Commission has published its 170-page proposal on revisions of the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic…
EU Pharma Package: Parliament and Council reach agreement to modernize EU pharmaceutical legislation - Key takeaways for pharma
European Union - December 12 2025 After the Council of the European Union (Council) adopted its negotiation position on the so-called Pharma Package in June 2025, the Council and the…
UPC: CE marking for a medical device as a trigger for “imminent infringement”, refining the standard on imminence, urgency, and territorial scope
European Union - December 5 2025 The UPC has granted a preliminary injunction effective for Germany, France, Italy, the Netherlands and Ireland against a Chinese medical device…
European Commission secures "pay for delay" victory in top EU court ruling
European Union - December 1 2025 The Court of Justice of the European Union (CJEU) has upheld a General Court (GC) judgment that sided with the European Commission (EC)’s decision to…
Europe’s increased focus on the environment and corporate sustainability: an expensive game changer for the pharma industry
European Union - November 19 2025 Over the past decade, the European Union has enacted a host of new legislation to protect the environment, promote sustainability and tackle climate…
Key takeaways from the LSX USA Congress
USA - October 15 2025 The life sciences and healthcare sector is an inherently collaborative and creative industry, and those traits remain crucial to Countering the…
Belgian Competition Authority issues guidance on information exchange between pharmaceutical companies for combination therapies
Belgium, European Union - October 13 2025 On September 11, 2025, the Belgian Competition Authority (the BCA) published a communication clarifying the conditions under which pharmaceutical…
The Hague District Court grants injunction against Glenmark for G-Standaard listing of eltrombopag 14 days prior to SPC expiry Novartis
European Union, Netherlands - September 29 2025 This case concerns infringement by Glenmark on Novartis’ SPC 300451 for eltrombopag (marketed as Revolade®). Novartis sought urgent relief after…
General Court annuls additional year of marketing protection for Biogen’s Tecfidera
European Union - September 25 2025 Eight companies marketing generic human medicinal products in the EU have each succeeded in persuading the General Court that a decision of the…
AI in healthcare: legal and ethical considerations at the new frontier
European Union, USA - September 16 2025 AI is already transforming drug discovery and diagnosis—and has the potential to do likewise across other elements of the healthcare industry. But to…
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