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,...
02 Sep, 2024 Abbott Diabetes Care Inc. v Sibio Technology Limited – an update By Gregory Bacon Aida Tohala This article was first published in Kluwer Blog [August, 2024]. Background In June 2024, we reported that in an application for...
19 Aug, 2024 CASGEVY: CRISPR/Cas9 gene therapy now available in England following NICE recommendation By Claire Smith Luca Cericola Vertex Pharmaceuticals announced a reimbursement agreement with NHS England for individuals 12 years or older with transfusion-dependent...
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...
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...
09 Jul, 2024 Lessons in expert selection By Hannah Rigby This article was first published in Kluwer Patent Blog [July 2024]. In his Abbott v Dexcom ([2024] EWHC 1664 (Pat)) judgment, published...
03 Jul, 2024 Abbott Diabetes Care Inc. v Sibio Technology Limited By Gregory Bacon Aida Tohala This article was first published in Kluwer Patent Blog [June, 2024]. Introduction On 19 June 2024, The Hague Local Division handed down a...
26 Jun, 2024 A new model clinical trial agreement – the good, the bad and (in its current form) the ugly By Claire Smith Adam Coughlin Introduction The NHS’ Health Research Authority (HRA) recently published its draft template Investigator Initiated Study Agreement (IIS...
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...
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...
28 Mar, 2024 Highlights from the WIRED Health Conference 2024 By Daniel Owen Will Hewitt We enjoyed an interesting day hearing about tech and healthcare at the recent WIRED Health conference. The conference brings together...