2/13/2026 10:49:00 AM Off the cliff, into the deal room: pharma M&A in 2026 and beyond By Mohammad Aljamal The global biopharmaceutical industry entered 2026 facing one of the largest waves of patent expirations in its history. The potential...
1/28/2026 4:35:53 PM A forensic dissection of revised classification Rule 11 – is there any basis for expecting software down classification? By Ellie Handy At the time the Commission published its “Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices”, making...
1/16/2026 2:38:37 PM Medical device simplification in detail: orphan and breakthrough device designations By Jamie Hatzel We wrote recently about the European Commission’s proposals to simplify the EU Medical Device Regulation (“MDR”)[1] and EU In Vitro...
1/16/2026 1:35:54 PM What Top 10 EU And UK Life Sciences Regulatory developments are we following in 2026? By Xisca Borrás There is so much legislative change in the EU and UK in the life sciences sector at the moment that it is sometimes difficult to keep up...
12/22/2025 10:30:42 AM Podcast: Navigating Femtech regulatory compliance in the EU – A legal conversation By Xisca Borrás Ellie Handy Those working in the Femtech space have a difficult regulatory framework to navigate in the EU. For products that qualify as a medical...
12/19/2025 1:34:38 PM The EU pharma package: what we know and what to expect By Xisca Borrás After years in the making, the much-awaited political agreement reached by the EU institutions on the so-called “EU pharma package” will...
12/19/2025 10:12:12 AM European Commission proposes dramatic simplification overhaul of medical device and IVD rules By Jamie Hatzel Xisca Borrás The European Commission has published its long-awaited proposal for a regulation to simplify the EU Medical Devices Regulation (“EU...
12/17/2025 1:23:59 PM European Commission consults on new regulation of medical device and IVD Notified Body activities By Jamie Hatzel The European Commission has recently published a draft implementing regulation under the EU Medical Devices Regulations (“EU MDR”)[1] and...
12/17/2025 10:07:55 AM Five key IP considerations for early-stage and spin-out biotech companies By Ellen Lambrix Harry Woodcock In this third, and final, article of our three-part series - Thinking early: key legal points for early-stage biotech companies - we are...
12/11/2025 11:14:00 AM Top five employment considerations for early-stage and spin-out biotech companies By Manon Rattle Tabitha Reed In this second article of our three-part series - Thinking early: key legal points for early-stage biotech companies - we cover the...
12/10/2025 9:43:25 AM Podcast: Early-stage funding for FemTech companies in the UK By Sophie Rees Anna Honey Gabriela Necula The FemTech sector, which focuses on technology for women’s health and wellness, is experiencing rapid growth in the UK. Out of the 540...
12/4/2025 3:30:11 PM Genesis 2025: Maximising returns from life science innovation By Louisa Jacobs Oliver Alsop Louisa Jacobs and Oliver Alsop attended this year’s One Nucleus Genesis conference, which brought together industry, investors,...