Francesca writes about a broad range of policy and regulatory topics, including intellectual property rights. However, her main areas of expertise are pricing and reimbursement and how medicines may or may not make it to patients. She writes about developments in Europe and is also expanding coverage in emerging markets, including Latin America and the Middle East. Francesca writes for Pink Sheet, Scrip and In Vivo.
Latest from Francesca Bruce
CMED, which sets medicine prices in Brazil, has published the maximum price adjustment index for 2025.
The Brazilian medicines regulator will also offer more clarity on the requirements for radiopharmaceuticals that are exempt from registration.
The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.
Sponsors of three drugs that are in the final stages of the EU regulatory review cycle are due to make the case for marketing approval before the European Medicines Agency.