19 Nov, 2024 Reasons to be cheerful: 4 takeaways from the BIA UK Life Sciences Regulatory Conference 2024 By Hugo Kent-Egan We had an insightful day hearing about the future of UK life sciences regulation at the BIA’s flagship annual Life Sciences Regulatory...
11 Nov, 2024 Priority Review Vouchers: another high value sale generates a significant return for licensor By Ellen Lambrix Luca Cericola On 5 November 2024, Acadia Pharmaceuticals Inc. ("Acadia") announced that it sold its rare paediatric disease priority review voucher...
05 Nov, 2024 Early Christmas present: MHRA consultation on international recognition of devices By Hugo Kent-Egan The MHRA has provided more information on its plans for rolling-out its new medical device framework. It aims to publish its additional...
30 Oct, 2024 Further revisions to the MDR and IVDR By Alex Denoon Last week, the European Parliament (EP) passed a resolution calling on the European Commission (EC) to further revise the Medica Devices...
07 Oct, 2024 Incoming: MHRA consultation on UK Medical Devices Regulations By Hugo Kent-Egan Alex Denoon On 25 September 2024, the MHRA updated its roll-out of the new medical device regulatory framework for Great Britain. The MHRA aims to...
02 Oct, 2024 TEAM-NB’s interpretation of “Structured Dialogue” between Manufacturer and Notified Body, clarifies little By Alex Denoon Anna Hall TEAM-NB has published a new version (v5.0) of its Code of Conduct for Notified Bodies. While we don’t normally comment on this Code,...
23 Sep, 2024 2024 ABPI Code of Practice launched - orange is the new blue By Jamie Hatzel The ABPI and the Prescription Medicines Code of Practice Authority (PMCPA) have announced the release of the latest edition of the ABPI...
13 Aug, 2024 UK – Samsung Bioepis v. Janssen Biotech / ustekinumab By Sophie Britton This article was first published in EPLAW blog [August, 2024]. Patents Court finds Janssen Biotech’s patent, for the antibody ustekinumab...
09 Aug, 2024 Podcast: EU AI Act – product safety By Alex Denoon Charlie Hawes Anneke Pol Numerous parallels can be drawn between the EU AI Act and product safety legislation - including risk classification for product...
10 Jul, 2024 Challenges and opportunities for bio innovation: Views from the ON Helix 2024 conference By Adam Coughlin Luca Cericola Last week, Adam Coughlin and Luca Cericola from Bristows’ Commercial IP team attended ON Helix 2024, an annual conference hosted by One...
08 Jul, 2024 Labour's planning reforms for the life sciences sector By Tim Allen Hugo Kent-Egan “To ensure available lab space scales to meet the ambitions of our fast-growing research-intensive industries, not least the life...
04 Jul, 2024 The EU AI Act as product safety legislation – lessons from the world of medical devices By Alex Denoon An AI system is classified as “high-risk”, the AI Act imposes significant requirements on the provider in order for it to place the...