Celebrex Polyp Trial Meta-Analysis Finds CV Risk In Line With Previous Findings
This article was originally published in The Pink Sheet Daily
Analysis of cardiovascular risk in the APC and PreSAP trials is consistent with current labeling warnings, firm asserts.
You may also be interested in...
Celecoxib labeling revision includes long-term safety data from three celecoxib trials, one of which suggests increased cardiovascular risk. Celebrex also gains ankylosing spondylitis indication.
DURHAM, N.C. - The decline in FDA's tally of new molecular entity approvals stems from fewer approvals of non-innovative products in recent years, while approvals of truly innovative products has largely held steady, according to FDA Deputy Commissioner for Policy, Planning and Preparedness Randall Lutter
Amgen's failed Anemia of Cancer trial of Aranesp and Panitumumab Advanced Colorectal Cancer Evaluation (PACCE) trial of Vectibix may illustrate the potential pitfalls facing sponsors that conduct "real world" trials of their products