STAT+: Pharmalittle: FDA declines to approve two more drugs tested in China; Pfizer Covid pill fails to prevent infection in household members
Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of online calls, meetings, and deadlines has predictably returned. But what can you do? The world, such as it is, keeps spinning. So on this cloudy day, we will brighten our spirits and forge ahead with a cup or three of stimulation. Our choice today is salted caramel mocha. Feel free to join us. Meanwhile, here are some tidbits to help you along. Hope you have a smashing day, and do stay in touch. …
The U.S. Food and Drug Administration declined to approve two China-tested cancer treatments on Monday, raising concerns over the future of drugs tested in single-country trials, Reuters reports. The FDA sent a complete response letter to Hutchmed stating its treatment for neuroendocrine tumors requires data from a trial that is more representative of the U.S. patient population. The agency also declined to approve a cancer drug from Coherus BioSciences and its Chinese partner, Shanghai Junshi Biosciences, for treating a type of nasopharyngeal carcinoma, citing the need for quality process changes.
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