5/19/2025 12:03:36 PM The Roadmap Ep 34: Medical Device Software Market on the Brink? The AI Act Alarm Bells are Ringing - Part 1 By Marc Dautlich Alex Denoon Team-NB, representing the majority of Notified Bodies for EU MDR and IVDR medical devices, has issued a stark warning: the implementation...
5/15/2025 10:35:28 AM Cell and Gene Therapy licensing: Complex regulatory pathways necessitate careful scrutiny of financial milestones By Luca Cericola Ellen Lambrix Alex Denoon This article was first published in the Bio-science Law Review (Volume 19, Issue 6) by Lawtext Publishing. Cell and Gene Therapies...
5/9/2025 11:16:48 AM Good news for patentees? An update on pharma PIs in the UK By Claire Phipps-Jones A recent case was brought before the High Court concerning Glenmark's alleged imminent infringement of AstraZeneca's patent covering its...
4/16/2025 11:30:02 AM New breakthroughs in healthcare - Our takeaways from the Wired Health Conference 2025 By Stefano Incarbone Naina Patel On 18 March 2025, Bristows attended the Wired Health 2025 conference, which took place at Kings Place in London. It was a day gathering...
3/26/2025 2:18:37 PM Consultation on clearances for R&D tax relief launched By Julia Cockroft Tabitha Reed The Spring Statement was remarkably quiet on the tax front but hidden in the materials was an announcement launching the consultation on...
3/21/2025 11:57:43 AM Plausibility in Focus: a fireside chat with Charlotte May KC By Adrian Chew Brian Cordery On 26 February 2025, two of our patent litigation experts, Brian Cordery and Adrian Chew, were joined by 8 New Square barrister,...
3/21/2025 9:45:58 AM UK Pharma leaders: VPAG is making the UK “un-investable” By Hugo Kent-Egan Alex Denoon Krishiv Desai Various UK pharmaceutical companies yesterday co-signed a report warning that future UK investment is unlikely unless the Government...
3/17/2025 3:46:52 PM Statutory Scheme repayments: the DHSC dots the i's and crosses the t's By Hugo Kent-Egan On Friday, the DHSC published the latest consultation to update the repayment percentage under the Statutory Scheme. This consultation...
3/14/2025 4:07:34 PM Tech Transfer rules review comes to the UK By Sophie Lawrance Hard on the heels of the European Commission initiation of a review of the 2014 Technology Transfer Block Exemption (TTBE) and Guidelines...
3/12/2025 3:06:22 PM Over a year on from VPAG: is there a VAT-shaped hole in the Government’s calculations? By Tabitha Reed Hugo Kent-Egan Julia Cockroft Xisca Borrás +1 more... Show less HMRC has been granted permission to appeal the First-Tier Tribunal’s VAT decision in the case of Boehringer Ingelheim Ltd v HMRC. We...
3/6/2025 12:51:53 PM Year of the NewCo? China’s emerging impact on global drug development By Sean Hess In 2024 biotech venture funding in Europe and the US saw a promising increase, reaching a total of $28.1 billion up from $21.2 billion...
2/11/2025 3:47:37 PM A Wellcome Development for SaMD – the UK Publishes Guidance on Digital Mental Health Technologies By Ellie Handy The MHRA and NICE published guidance on “Digital mental health technology: qualification and classification” (the DMHT Guidance) last...