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New EU Filings

A regularly updated list of new marketing authorization applications at the EMA

Executive Summary

Y-mAbs Therapeutics' omburtamab and Oncopeptides' melflufen are among 13 potential new treatments that have been submitted for pan-EU approval.

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First Academic Sponsor On EMA’s PRIME Pledges Cheaper CAR-Ts

An investigational CAR T-cell therapy that hospital researchers in Spain believe they could produce at a third of the price of commercially available CART19 products has been accepted onto the European Medicines Agency's priority medicines scheme.

New EU Approvals

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add one new product – Lumykras, Amgen’s treatment for advanced non-small cell lung cancer.

Lynparza Rejection Highlights ‘Two-Tier’ Funding Problem In UK

Health technology assessment body NICE has said that Lynparza from AstraZeneca and MSD is not a cost-effective use of National Health Service resources in England for prostate cancer patients at the price at which it is currently being offered. AZ and NICE say they will try to reach an agreement.

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