US FDA Gets Out Of The 'Competition' Business – At Least In Oncology
The US FDA often reminds advisory committees that price is not part of its mission, but the agency pointedly told the experts meeting to review Lilly/Innovent’s sintilimab that “competition” should not be a factor either. Do they really mean that?
You may also be interested in...
Going Global Gets Stuck, Chinese Drug Makers CRL Show What Not To Do
Chinese drug makers have more to lament and plenty to learn from as Junshi, HutchMed follow Innovent Bio with FDA rejections. A holistic not opportunistic approach is needed, one ex-FDA expert suggests.
No Love: Chinese Oncology Firms Scramble To Cope With New US Reality
After a high-profile FDA advisory committee rejection of potentially the first "Made In China" cancer drug in the US, from Innovent Bio and partner Lilly, many Chinese oncology companies are now quietly looking for the next step forward.
Casualty Of Change? Innovent/Lilly’s Chinese PD-1 Inhibitor Sintilimab Falls Hard At US FDA Panel
Advisory committee says additional trials needed to demonstrate applicability of ORIENT-11 results to US population; in opting to seek approval only with Chinese data, Innovent said it relied on 2019 comments by FDA’s Richard Pazdur, but the oncology center head said therapeutic and societal changes have caused an evolution in the agency’s thinking.