Eight EU marketing authorization applications are up for an opinion this week from the CHMP, the European Medicines Agency committee that recommends whether or not products should be approved.
Clovis Oncology is hoping to be proved right in its assumption that the positive feedback the European Medicines Agency recently conferred on its investigational ovarian cancer drug Rubraca (rucaparib) will this week translate into a formal recommendation for EU market approval.
Rubraca, which has orphan drug status, is one of eight products that the EMA’s human medicines committee, the CHMP, is...
As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.
The AI observatory, created by the European medicines regulatory network to track the evolving use of artificial intelligence in medicines development and regulation, has issued its first annual report.
In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.
