FDA wary of drugs developed in China

The FDA is concerned about the quality of studies evaluating cancer drugs and other new medicines developed in China. The agency’s reservations could disrupt the plans of Western drugmakers, including Eli Lilly and Novartis, which planned to sell China-developed drugs in the U.S. in 2022. The FDA’s advisory committee is set to vote Feb. 10 on whether the agency should approve the drug Tyvyt, a lung-cancer immunotherapy developed by China’s Innovent Biologics, and whether the results should be generalizable to the American population. ‘We have nothing against drugs being developed in. China,’ said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence. ‘Our issue is. . . .