Latest From Maureen Kenny
The Pink Sheet's EU accelerated assessment tracker has been updated to include developments relating to experimental products from Atara, Calliditas, and Roche.
The outcomes of a handful of requests for accelerated assessment at the European Medicines Agency appear not yet to be in the public domain. In the meantime, there's been good for news for Atara's tab-cel and a switch to standard review for Nefecon from Calliditas.
In the first half of 2021, just six requests from companies seeking accelerated assessment of their planned EU marketing authorization applications were granted; 11 were rejected. The outcomes of five decided on in July and August are still unknown.
If Immuncore's tebentafusp is fast-tracked all the way through the centralized procedure at the EMA, it could be approved a few months earlier than it otherwise would be.
bluebird bio's decision to wind down commercial initiatives for its gene therapy business in Europe is a blow for the sector in the region as a whole.
Takeda says loss of accelerated assessment status at EMA for marketing authorization application for its dengue vaccine candidate TAK-003 “was anticipated as a potential outcome.”