source
- Regulatory experts urge risk-based, lifecycle validation for AI tools in FDA workAt the RAPS AI in Regulatory Conference in Barcelona, a panel of experts discussed the growing use of AI tools by regulatory professionals. They recommended a risk-based, lifecycle approach to val…
- Novartis Lp(a) drug pelacarsen shows no cardiovascular benefit, raising doubts on Amgen and Lilly programsNovartis disclosed that its phase 3 Lp(a)Horizon trial of pelacarsen, an antisense oligonucleotide partnered with Ionis, failed to demonstrate any reduction in major cardiovascular events. The drug…