Latest From Francesca Bruce
In addition to agreeing to emergency use of the Oxford University/Astra Zeneca and Sinovac vaccines, Brazil's medicines regulator has also published good manufacturing practices certificates for Pfizer and Janssen vaccine. It has questions about the Sputnik V authorization request.
A Dutch parallel registration and reimbursement pilot has brought benefits including more participation from healthcare professionals, and also forces company divisions to be less streamlined.
The UK’s withdrawal from the EU could upset the Unitary Patent Court project.
International reference pricing has created narrow price corridors that can limit access to medicines and vaccines in lower income countries. The issue will start to impact higher income EU markets if US plans to introduce IRP come to fruition.
Innovators warn against slashing incentives and argue a lack of a common definition of unmet need is a stumbling block to proposals.
Zolgensma has exceeded the orphan sales threshold in the six months it has been on the market in Germany and the gene therapy must now undergo a full benefit assessment.