Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Vanda And Nektar Persevere With Fanapt And Onzeald In EU

Executive Summary

The two products that the European Medicines Agency’s key scientific committee, the CHMP, decided last week should not be approved in the EU were Vanda’s schizophrenia treatment Fanaptum (iloperidone), and Onzeald (etirinotecan pegol), a potentially new treatment for breast cancer with brain metastases from Nektar/Daiichi Sankyo Europe. The companies want the CHMP to look again at the negative opinions they received.

You may also be interested in...



Lilly, Nektar Partner On 'Stimulating' IL-2 Drug In Autoimmune Diseases

Nektar taps into Lilly's immunology know-how for fast development of NKTR-358, which targets IL-2 to stimulate the body's own inflammation-inhibiting Tregs rather than suppress the immune system.

EU Marketing Approval In Sight For 11 Drugs After CHMP OK; Thumbs Down For Two

The European Medicines Agency’s key scientific committee, the CHMP, has recommended for approval throughout Europe a total of 11 new drugs. Two medicines received a negative opinion from the committee and the marketing authorization application for one product has been withdrawn. A further eight products are set to receive indication extensions. The medicines that got positive opinions are likely to secure official approval within the next few months.

EU CHMP Decides On New Oncology Drugs & New Treatments for Mastocytosis, Atopic Dermatitis

The European Medicines Agency’s key scientific committee, the CHMP, is deciding this week whether a dozen or so new medicines that are in the final stages of the evaluation process should be approved for marketing across the EU. The committee will discuss 13 initial marketing authorization applications.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS121174

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