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
Brazil’s drug regulator has published a new technical note updating guidelines on registration and post-registration procedures for biological products.
Nirogacestat was one of four products scheduled for an oral explanation meeting at the European Medicines Agency this week.
The European Medicines Agency is this week expected issue opinions on whether the European Commission should grant EU marketing authorization for 19 new products.
France’s simplification bill is a “first step” to improving the country’s clinical research environment, but more could be done to drive decentralized trials and simplify processes, says Leem, the French pharmaceutical industry association.
A blanket pricing agreement CSL has formed with German health insurers for the gene therapy, Hemgenix, makes the cost of treatment budget-neutral compared to traditional treatment.
A new European initiative will help trial sponsors better understand whether digitization and decentralized clinical trials of drugs generate less carbon than traditional methods.