All Insights
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Life Sciences and Healthcare
Will a new European Biotech Act unlock the full potential of biotechnology in the EU?
Call for evidence on the upcoming legislation underlines the importance of the biotech sector for the EU economy
IT and data
UK Cyber Security and Resilience Bill will be both similar and different to the EU's NIS 2
Businesses can still assess ahead of the UK bill's publication if they could be caught and their potential obligations
Regulatory and compliance
European Commission publishes new single market strategy to further develop the European market
Proposal to ease burdens on smaller businesses and lift barriers to trade and investment likely to have positive impact on
Life Sciences and Healthcare
What are the main features of the Spanish Preliminary Draft Law on Medicines and Medical Devices?
Recent challenges faced by the health sector have led to a comprehensive reform of pharmaceutical legislation in Spain, aligning the
Competition, antitrust and trade
What's in the UK and India's historic trade deal?
After years of on-off negotiation, the deal should unlock significant opportunities for businesses in both countries
Life Sciences and Healthcare
Can newly enacted UK rules simplifying approval for precision bred plants survive the EU reset?
Genetic tech regulations set to come into force in November but UK and EU agree dynamic alignment on agrifood products
Life Sciences and Healthcare
Will the UK government implement recommendations for the engineering biology sector?
Government responds to recommendations from Lords committee and Regulatory Horizons Council
Unified Patent Court
Infringement claim amendment allowed to include non-UPC territories after CJEU Electrolux decision
Munich local division decided amendment could not be made earlier so allowed Syngenta to extend claim to Czechia, Poland and
Life Sciences and Healthcare
Court of Appeal overturns English Patents Court and grants interim injunction to prevent 'at risk' generic launch
Patents Court found wrong to hold damages would be an adequate remedy for AstraZeneca
Life Sciences and Healthcare
EU court issues significant decision on pharma-device 'borderline' product case
European ruling clarifies the definition of pharmacological action for health products
Intellectual property
European Council adopts negotiating mandate on patents for gene-edited plants
EU moves closer to regulatory change for gene-edited plants but still a long way to go
Life Sciences and Healthcare
EU proposes tailored approach to streamline biosimilar development
New EMA reflection paper signals a step change in biosimilar approval, reducing requirements while maintaining standards