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...
25 Jun, 2024 Biotech Review of the Year: Six months on By Bristows LLP It's hard to believe that six months have passed since we released the 11th edition of our Biotech Review of the Year publication. Our...
17 Jun, 2024 Licence Agreements for Cell and Gene Therapies By Claire Smith Ellen Lambrix Louisa Jacobs This article was first published in The Licensing Journal (Volume 44, Number 4). You can read and/or download it, in full, below: Cell...
13 Jun, 2024 Takeaways from the EU Pharma Law Forum 2024 By Jamie Hatzel Bristows was delighted to sponsor and attend this year’s EU Pharmaceutical Law Forum, which was held in Brussels at the Steigenberger...
24 May, 2024 Clinical combinations: ever increasingly, two study products are better than one By Claire Smith Adam Coughlin Forgive the poetic licence but it feels like almost every week a new agreement for a clinical combination therapy lands on our desks....