Ilaris Diabetes, Cardiovascular Trials Are Unethical, Public Citizen Says
This article was originally published in The Pink Sheet Daily
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
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.
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.