Articles: 1-10 of 79
The EU’s 2025 proposal to simplify the Medical and In-Vitro-Diagnostic Devices Regulations (MDR/IVDR)
European Union - December 19 2025 On 16 December 2025, the European Commission published its proposal to simplify the EU’s Medical Devices Regulation (Regulation (EU) 2017/745) (MDR)…
EU Biotech Act Unveiled: Commission’s Proposal to Turn Europe into a Biotech Powerhouse
European Union - December 19 2025 On 16 December 2025, the European Commission published its long-awaited Proposal for a Biotech Act with an aim to “build a world-leading…
EU Pharma Package: A Landmark Political Deal Sealed
European Union - December 11 2025 In the early morning of 11 December 2025, the Council and European Parliament have reached a major political agreement on the overhaul of the general…
Medical Devices and In Vitro Diagnostic Regulations: Brussels Signals It’s Ready to Cut Red Tape?
European Union, United Kingdom - September 18 2025 Brussels has finally blinked. On 8 September 2025, the European Commission launched a call for evidence to simplify the MDR and IVDR. The window is…
The MHRA’s Summer Glow-Up: UK Medical Device Laws Get a Makeover
United Kingdom - August 28 2025 The MHRA didn’t take a summer break this year, so while we were packing our suitcases, the MHRA has been packing in the device reforms. We’ve set out…
Strategic Decisions for Business Continuity
USA - July 30 2025 Organizations in the healthcare and life sciences sector are facing new trade winds and tariffs that further complicate their supply chains. This…
EU and German Courts Clarify Rules on Rx Drug Discounts in latest DocMorris decisions
European Union, Germany - July 28 2025 With its ruling in Apothekerkammer Nordrhein v. DocMorris (Case C-517/23), the Court of Justice of the European Union (CJEU) provided further clarity…
Mitigating Risk in Life Sciences Acquisitions
USA - July 17 2025 In the race to innovate, life sciences companies are betting big on M&A, but navigating the risks requires smarter deal structures Big pharmaceutical…
Council Clears Path to Trilogue on Pharma Package with Reduced Market Protection and stepped up Access Obligations
European Union - June 11 2025 After nearly two years of negotiations, the Council of the EU has adopted its negotiating position on the proposed revision of the pharmaceutical…
External Control Arms Based on Real World Data: MHRA Consultation Opens
United Kingdom - May 21 2025 On International Clinical Trials Day, the UK’s MHRA unveiled a major shift: a consultation on using external control arms (ECAs) based on real-world…
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