Science

AI tools are already advancing patient care by opening up new avenues for drug and product discovery, evaluation, and pharmacovigilance. But they also raise regulatory challenges as our panelists discuss.
The post The AI Revolution and the FDA: Becky Wood and Deeona Gaskin’s Fireside Chat with Former FDA Commissioner Dr. Scott Gottlieb appeared first on

A recent SEC enforcement action against Cassava Sciences over misleading statements made to the FDA about clinical trial (CT) results highlights the importance of life sciences companies exercising care in how they disclose FDA-related information to investors. Lara Mehraban explains.
The post SEC Interest in FDA-Related Disclosures by Life Sciences Companies Highlighted appeared first on

As the life sciences sector grapples with complex challenges around sustainability and Environmental and Social Governance (ESG) compliance, Generative AI (GenAI) is emerging as a potentially powerful tool for enhancing efficiency and sustainability. Michele Tagliaferri, Eva von Mühlenen, and Anna-Shari Melin explain.
The post Risks and Benefits of Generative AI for Pharma Supply Chain Management

The European Medicines Agency (EMA) has published a final reflection paper on the use of AI in the drug lifecycle, which provides important insights into the expectations from the EMA to clinical trial sponsors, as well as marketing authorization (MA) applicants and holders who use AI systems. Josefine Sommer and Zina Chatzidimitriadou explain.
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The EU’s proposal to speed up generic and biosimilar market access by expanding the “Bolar exemption” to pricing and reimbursement procedures raises significant international IP law concerns, as it is probably incompatible with its obligations under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Maarten Meulenbelt, Chris Boyle, Lauren Shapiro, Maryanne Kamau,