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

NICE Backs Xgeva for Oncology But Excludes Prostate Cancer Indication

This article was originally published in The Pink Sheet Daily

Executive Summary

A significant discount from Amgen has left NICE more than happy to pass Xgeva, but it still found economic grounds to reject the company’s application for a prostate cancer indication.

You may also be interested in...



Xgeva Rejection Shows What’s Needed For Non-Metastatic CRPC Approvals

As expected, FDA rejected the new indication for Amgen’s bone drug Xgeva in prevention of bone metastases. But the door is still open for other therapies for castration resistant prostate cancer to target earlier stages of disease.

Medivation Aims To Capture Prostate Cancer Market, One Trial At A Time

Phase III data for Medivation's MDV3100 suggest the prostate cancer drug stands to unseat J&J’s market leader Zytiga in many of the disease settings.

MHRA’s Beneficial EU Relationship And Profitable Synergies With NICE: An Interview With Michael Rawlins

In December, Michael Rawlins was appointed head of the U.K.’s Medicines and Healthcare products Regulatory Agency. He recognizes the MHRA’s mutually beneficial relationship with European counterparts and is looking to safeguard synergies with other national regulatory bodies and NICE.

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS073414

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