Insights from Day Four of the BIO International Convention include FDA commissioner Califf on the state of real-world evidence and how it impacts IRA negotiations, Roche's interest in cardiovascular/metabolic assets, Merck's plans in immunology, and industry's rising interest in neuropsychiatry. 

Insights from Day Three of the BIO International Convention in San Diego include Amgen CEO Bob Bradway taking aim at the "Innovation Reduction Act," Novo Nordisk's business development head talking about spending its semaglutide bounty, Roivant's  long view on BD prospects for Immunovant's FcRn inhibitor, and more regulatory concerns around artificial intelligence. 

Insights from Day Two of the BIO International Convention in San Diego include user fees potentially supporting the FDA's AI ambitions, the evolving pros and cons of partnering, and J&J's view on dealmaking in 2024.

Insights from the first day of the international convention in San Diego also includes interviews on Alzheimer’s investments, dealmaking for mid-sized companies and reflections on the virtues of lean thinking.

Pink Sheet reporter and editors discuss what an upcoming listening session means for the FDA’s advisory committee reform effort, the agency’s efforts to help clinical trial modeling and simulation, and the UK’s MHRA plan to use artificial intelligence to assist in drug reviews.

Pink Sheet reporter and editors discuss the impact of FDA biosimilar promotion guidance on the future of the interchangeability designation, upcoming guidance on accelerated approval for gene therapies, and partisan attacks on the agency from Capitol Hill.