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

Ilaris Diabetes, Cardiovascular Trials Are Unethical, Public Citizen Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Group says there is no preliminary evidence to suggest the drug would be beneficial for these indications.

You may also be interested in...



Avastin Recommended For Breast Cancer Approval In Japan; Telaprevir Leads List Of Unanimous Recommendations

TOKYO - Telaprevir and a metastatic breast cancer indication for Avastin (bevacizumab) were among the blanket recommendations for approval by the Second Subcommittee on New Drugs of Japan's Ministry of Health, Labor and Welfare announced late in the day Aug. 25. Avastin's recommendation came just a few weeks after the subcommittee had expressed doubts about the drug's efficacy

Ilaris Gout Review Reflects Tougher FDA Approach To Biologic Dosing Safety

FDA’s review of Novartis’ sBLA for Ilaris (canakinumab) in gout reflects an evolving agency philosophy toward dose optimization for biologic agents – an approach that is likely to require more sponsor attention to pre-approval dose exploration studies.

Ilaris Safety Data Inadequate For Gout Indication, FDA Panel Says

Arthritis Advisory Committee votes against approval of Novartis' biologic for treatment of gout attacks, citing the need for more data on long-term safety and retreatment, along with a narrower indication.

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS072539

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