Top of the morning to you. Another hectic day is unfolding here on the Pharmalot campus, where we are mulling over our cluttered calendar and plotting our next moves. No doubt, you can relate. After all, this is only the middle of the week and there is much to be done. This calls, as you may imagine, for a cup or three of stimulation. We are returning today to salted caramel mocha, a taste of the Jersey shore, such as it is. Feel free to join us. Meanwhile, here are some tidbits. The world is a busy place, yes? Hope you make your way today. …
Richard Pazdur, one of the most powerful regulators at the U.S. Food and Drug Administration, flung open the door to Chinese cancer drugs a few years back, but is now closing that door — a reversal with implications for Chinese companies and their U.S. partners, STAT writes. Pazdur highlighted several reasons for changing his mind. He believes data derived entirely from a single foreign country — China, most often — mark a “step back” from efforts championed by the FDA and drug makers to increase the racial and ethnic diversity of clinical trial participants. Chinese data are not “generalizable” to American cancer patients, and “do not fulfill an unmet medical need” in the U.S.
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