ATMP For Metastatic Cervical Cancer Among Nine New Products Under EMA Review
Executive Summary
Nine new products have been added to the list of products that the European Medicines Agency is reviewing for marketing authorization.
You may also be interested in...
Fremanezumab Among Latest EU Drug Hopefuls While Patients Speak Up On Pacritinib
Marketing applications for Teva’s migraine prevention CGRP inhibitor, fremanezumab, and CTI BioPharma’s myelofibrosis treatment, pacritinib, are among a number of submissions scheduled for discussion this week by the European Medicines Agency’s drug evaluation committee, the CHMP.
EU Yes For TiGenix Marks Tenth ATMP Approval in Ten Years
TiGenix says its treatment for complex perianal fistulae in Crohn’s disease is the first allogeneic stem cell therapy to be approved under Europe’s centralized marketing authorization pathway.
Is Imfinzi The Culprit As Advaxis Combo Trial Goes On Hold After Death?
The FDA has placed a clinical hold on a Phase I/II trial for HPV-related cancers of Advaxis' axalimogene filolisbac in combination with Imfinzi after a patient died due to respiratory failure but analysts at Jefferies believe the fault could lie with AstraZeneca's PD-L1 inhibitor.