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In this issue: Competition in life sciences Disputes and regulatory enforcement Regulatory framework for medicinal products Medical devices Research and development Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Competition in life sciences CAT publishes decisions on Allergan PLC v CMA cases The Competition Appeal Tribunal (CAT) has released two judgments on the Competition and Markets Authority’s (CMA) conclusion that Auden/Actavis UK paid AMCo/Advanz to keep its own 10 mg hydrocortisone tablets off the market. In the first, the tribunal upholds the decision on the facts and dismisses every ground of appeal. In the second, it allows the appeals because the CMA failed to put its case fully to a witness during a two‑day cross‑examination at trial, thereby overturning nearly £100m in fines for the drug companies, despite earlier confirmation of flagrant anti‑competitive conduct. The CMA has said that permitting these ‘due process’ appeals on...
Competition policy CAT has issued a Practice Direction setting out binding rules on formatting and page lengths for skeleton arguments and other papers lodged with CAT. Practice Direction 2/2005 prescribes mandatory standards for layout and page limits applying to skeleton arguments and related documents submitted in CAT proceedings. This new Practice Direction replaces the previous direction on skeleton arguments and supersedes the page‑limit guidance contained in the 2015 Guide to Proceedings herein too...
In this issue: UK, EU and international regulators and bodies Accountability, culture and social governance Prudential requirements Financial crime and sanctions Investigations, enforcement and discipline Regulation of benchmarks and IBOR reform Regulation of capital markets Sustainable finance and ESG Banks and mutuals Investment funds and asset management EU MiFID II Regulation of insurance FSMA regulated pensions activity Payment services and systems Fintech and cryptoassets Regulation of AI in FS Post-Brexit regulatory developments LexTalk®Financial Services: a Lexis®Nexis community Financial Services Enforcement Database Daily and weekly news alerts Intraday news alerts New and updated content Dates for your diary Latest Q&As UK, EU and international regulators and bodies EBA outlines work programme for 2025 The European Banking Authority (EBA) has released its programme of work for 2025. As set out in its plan, alongside other priorities next year, among other mandates,...
This Practice Note sets out an overview of the URS, a rights protection mechanism closely modelled on, yet distinct from, the Uniform Domain Name Dispute Resolution Policy (UDRP) and elements of the .uk Nominet Dispute Resolution Service (DRS). The URS provides a fast‑track, lower‑cost route for the most clear‑cut instances of cybersquatting. This Practice Note does not cover the UDRP or the DRS. For more on those, see the following Practice Notes: Uniform Domain Name Dispute Resolution Policy (UDRP) process Preparing a UDRP complaint—before you start Nominet dispute resolution service (DRS) Application and purpose of the URS The URS applies to: all new generic Top Level Domain Names (new gTLDs) some of the so‑called legacy gTLDs (namely .asia, .biz, .cat, .info, .jobs, .mobi, .museum, .org, .pro, .tel, .travel, .xxx) some country code top level domains (eg .pw for Micronesia) The URS was adopted in 2013 as part of a suite of strengthened rights...
Advances in medicine, biomicrobiology and biotechnology have given rise to a state-of-the-art group of medicinal interventions that deploy gene therapy, somatic cell therapy and engineered tissues to prevent, manage or even cure human disease. The newness, intricacy and variety of these products has required fresh regulatory instruments, both legislative measures and guidance, to strike an appropriate balance between risks and patient benefits. In the EU and the UK, lawmakers classify this group as ‘advanced therapy medicinal products (ATMPs)’ to safeguard the highest standards of public health while recognising their unique challenges, particularly around clinical trials, manufacturing and pharmacovigilance. Yet oversight of genetically modified organisms (GMOs) used as starting materials for ATMPs remains a national matter and therefore varies from one Member State to the next. These divergences have produced a complicated regulatory environment for ATMPs. Oversight of tissues and cells is likewise presently handled at national level, although such inconsistencies are expected to continue only until 2027, when a revised EU regulation is anticipated to take effect. This Practice Note...