EMA

Following promising Phase II data presented at ASH on the company's allogenic leukemia-derived dendritic cell vaccine, Mendus has secured support from the FDA and the EMA for pivotal studies starting later this year.

New guidance on data transparency from European medicines regulators will mean more administrative burden for small and medium sized companies.

The European Medicines Agency is encouraging companies to submit the type I variations they want to make to their marketing authorizations by the end of this month.

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

Having its own priority review vouchers could serve as an important pull incentive for neglected disease R&D in Europe, although the unpredictable nature of the vouchers may deter some investors.