New measures for the security assessment of data transfers from China to other countries could make things harder for international pharma companies with China operations, and companies have until 28 February to work out if they are affected. Lianying Wang explains
Josh Hofheimer reports the takeaways from Sidley’s co-hosted pitch day with KoreaBio and BioCentury at the J.P. Morgan Healthcare Conference. The session included key insights on entrepreneurial developments and an investor panel on macroeconomic challenges.
Sidley’s 2023 Global Life Sciences Trendspotting Report maps out seven key trends in the life sciences industry globally, and identifies some regional trends in the U.S., China, and Europe which are likely to have global ramifications during the coming year.
Decentralized clinical trials are on the rise in the EU and the UK. This month, new EU level guidance on how to conduct them has supplemented existing guidance on the topic. Zina Chatzidimitriadou, Lauren Cuyvers and Bronwyn Tonelli give seven considerations for decentralized trial sponsors in the region.
The Biden administration is conducting investigations into potential antitrust violations to which the life sciences industry may be particularly vulnerable because having board members sit on more than one company is relatively common. Benjamin Nagin and Kristina Gliklad explain.
A new Executive Order in the U.S. aims to ease the path to market for products that use synthetic biology or genome editing. Emily Marden explains the thinking behind the announcement and its efforts to streamline the current U.S. framework for biotech.
Chris Fanelli explains what the U.S. Food and Drug Administration’s new draft guidance on remote regulatory assessments means for site inspections in the future, and how manufacturing facilities can prepare for requests for Remote Regulatory Assessments.