Foreign Data: Sintilimab’s Development Shows What Not To Do When Pursuing US Approval
Executive Summary
The FDA’s concerns about conduct of ORIENT-11 trial include adequacy of informed consent, uncertainty about confidence in data generated in China, and failure of development partners Innovent and Eli Lilly to consult the US regulator about the study’s design.
You may also be interested in...
BeiGene Is Keeping The Faith In IO/IO Combinations
Global head of R&D Lai Wang talked to Scrip about his expectations for a PD-1/TIGIT combination and remaining confident about the potential of IO/IO combinations in cancer despite disappointments.
BeiGene Head of R&D Lai Wang On Going Global
The Chinese company's R&D leader discusses the US regulatory environment for Chinese-made drugs and implications for the cancer-focused company.
BeiGene Head of R&D Lai Wang On Going Global
The Chinese company's R&D leader talked to Scrip about the US regulatory environment for Chinese-made drugs and implications for the cancer-focused company.