EMA

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include nine new products, one of which is Kostaive (zapomeran), CSL/Arcturus Therapeutics’ self-amplifying mRNA COVID-19 vaccine for individuals 18 years and older.

Kostaive is the first self-amplifying mRNA COVID-19 vaccine to receive approval from the European Commission and could provide serious competition to Pfizer/BioNTech's Comirnaty and Moderna's Spikevax.

The European Medicines Agency believes its plan to develop guidance for reporting and evaluating mechanistic models used for MIDD would also benefit from input from other regulatory agencies, such as those in the US, Japan and Canada.

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.