Those medtech companies which embed AI into an app allowing healthcare professionals or patients to ask questions and to receive a response will probably need to comply with China’s new Interim Measures for the Management of Generative Artificial Intelligence Services (the “Measures”). Lianying Wang explains.
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New EU Subsidies Rules Likely to Catch Global Life Sciences Companies
Given their extensive involvement in public procurement contracting, life sciences companies are likely to be heavily impacted by the EU’s Foreign Subsidies Regulation (the “FSR”), which has the potential to hold up tender awards over competition concerns. Michele Tagliaferri and Alessandra Moroni explain.
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AI-Powered Drug Discovery Efforts Could Lead to New Treatments
Stephen Abreu, Sidley partner, talks to Colin Hill, CEO and Co-Founder of AI-powered drug discovery company Aitia, about how the use of AI is revolutionizing the biotech space.
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Europe’s Regulatory Approach to Continuous Learning AI
The regulation of continuous learning models involves the challenge of navigating the future. The EU is striving to stay ahead of the game with its forthcoming AI Act and harmonised standards. Eva von Mühlenen, Oliver Haase of Validate, and Leon Doorn of Aidance discuss.
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Innovation, Collaboration, and Access to Capital: Key Takeaways from the Sidley Healthcare Investment Conference
At Sidley’s Healthcare Investment Conference on 12 September, speakers analysed the flow of capital across the global life sciences and healthcare ecosystem in panels discussing collaborative deals, sources of funding, the regulatory scrutiny of deals, and women’s health.
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Five Governance Steps To Consider When Using Generative AI Within A Pharma Company
Pharma companies are looking to better understand how Generative AI (GAI) can facilitate innovation. Early adopters can gain distinct advantages while properly managing the top-of-mind potential risks discussed below. Francesca Blythe and Steve McInerney explain the corporate governance principles that should be considered.
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Start Thinking About Human Rights and Environmental Impact of Subsidiaries and Value Chains
The impending EU Corporate Sustainability Due Diligence Directive (“CS3D”) means most EU and some non-EU law sciences companies should begin to assess their wider human rights and environmental impacts and rethink compliance programmes. Michele Tagliaferri explains.
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Four Tips for Successful Development of Cell and Gene Therapies
Developing a cell or gene therapy (CGT) involves a range of regulatory considerations and challenges. Emily Marden and Jaclyn Fonteyne point to some key factors that are currently the focus of FDA attention and may merit consideration by sponsors early in the development process.
The FDA’s Center for Biologics Evaluation and Research (CBER) has indicated…
Seven Things Life Sciences Buyers and Sellers Should Know About CVRs
The life sciences industry has recently seen a proliferation of Contingent Value Rights (CVRs), the public M&A equivalent of the earnout used in private deals. Sally Wagner Partin, Sharon Flanagan, and Hannah Brown explain what you need to know about them.
CVRs are a mechanism for bridging valuation gaps between buyers and sellers in public…
U.S. and EU Expand Mutual Recognition Agreement to Include Animal Drugs
Sites making animal drugs need to be inspection-ready, as a single inspection report can now be relied upon by regulators in both the U.S. and some EU member states. Multi-jurisdictional regulatory actions could ensue. Christopher Fanelli, Chris Boyle and Yuzhi Hu explain.
The U.S. Food and Drug Administration (FDA) and the European Union (EU) has…