Roche And Shionogi Aim For EU Accelerated Assessment
Roche will learn this week if two potential anticancers it is developing - polatuzumab vedotin and entrectinib - will be okayed for fast track regulatory review when they are filed in the EU.
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In 2018, the European Medicines Agency considered 24 requests from drug companies for fast-track review of their planned marketing authorization applications. The agency has granted at least nine requests, eleven have been rejected and the results of four have yet to be disclosed.
The European Medicines Agency has okayed applications from Roche for EU accelerated review of two oncology drugs in late-stage development at the company.
Investigational drugs for sickle cell disease and diffuse large B cell lymphoma from Global Blood Therapeutics and Roche respectively have become the latest products to make it onto the European Medicines Agency’s PRIME scheme for speeding the development of drugs for unmet medical need.