Brintellix Review To Focus On Cognitive Function Measurement
This article was originally published in The Pink Sheet Daily
Executive Summary
Takeda's request for novel claim for an antidepressant hinges on FDA acceptance of clinical outcomes assessment used in vortioxetine's trials, but agency raises doubts about utility of results.
You may also be interested in...
Brintellix Label Gives Lundbeck Ground For Tolerability Claims
Lundbeck/Takeda’s newly approved antidepressant Brintellix is poised to enter the crowded, genericized antidepressant market at the end of 2013. Potential advantages in labeling include flexible dosing, lack of weight gain and lower rates of sexual dysfunction compared to some other drugs.
Drug Shortages, Inspections In Focus At US FDA Appropriations Hearing
Commissioner Robert Califf discussed the agency’s request for $12.3m to address shortages and legislation to require that manufacturers provide more detailed information about increased demand and supply chain vulnerabilities.
Clinical Trial Diversity Requires Sponsors Work With An Assortment Of Patient Advocates, Community Organizations
US FDA oncology officials are concerned that the entities sponsors are consulting in developing and implementing clinical trial diversity plans are not sufficiently diverse themselves and do not represent patients in underserved communities.