Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Enhertu Nabs A First With UK Standalone Approval

Advanced Breast Cancer Treatment Is First New Cancer Drug Approved In 2021

Executive Summary

The UK conditional approval of Daiichi Sankyo/AstraZeneca’s advanced breast cancer drug Enhertu was issued in accordance with “transitional provisions” that apply to drugs that received a positive opinion from the European Medicines Agency before the end of the Brexit transition period.

You may also be interested in...



NICE Funding Wins For Enhertu & Kesimpta Are Firsts For England

UK health technology assessment body NICE has struck deals with the makers of Enhertu for advanced breast cancer and Kesimpta for relapsing forms of multiple sclerosis.

Seagen Debuts In EU With Tukysa Launch & Sees UK As 'Key' Future Market

Tuomo Pätsi of US biotech firm Seagen discusses plans for the rollout of Tukysa in Europe, how it successfully used a new mechanism for approval in Great Britain, and why the UK will be a go-to market for future innovative drug filings.

UK Explains New ‘Reliance’ Routes To Approval Based On EU Dossiers

Companies seeking marketing authorizations in the UK or Great Britain will be able to make use of two new “reliance” procedures offering regulatory assessment times of 67 days or less if their products have already gone through the EU centralized or decentralized approval systems.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS143795

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel