And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda, once again, is exceedingly modest. We plan to catch up on our reading, promenade with the official mascot, and take naps. And what about you? This is a fine time to enjoy the great outdoors — a brisk walk in the park, a run down on a slope, or a trek through the woods is good for the soul. You could also stock up on all sorts of sundry goods before prices climb still further. Or you could touch base with an older someone who feels a bit isolated these days. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …
A panel advising the U.S. Food and Drug Administration decided Eli Lilly (LLY) and its Chinese partner, Innovent Biologics, should conduct more studies of a lung cancer drug to win approval, STAT tells us. The advisers voted 14 to 1 to recommend additional testing after agency officials said a Chinese study of the drug had significant issues and the results were not “generalizable” to a more diverse population of Americans with lung cancer. The vote is a sign of a tougher FDA stance on drugs that are tested only or predominantly in China. FDA officials recently cited concerns about the quality of studies conducted largely in China and whether the results can apply to U.S. patients.
In response to a Medicare proposal to restrict coverage to its controversial Alzheimer’s drug to clinical trial participants, Biogen (BIIB) wrote to the agency with a counterproposal, STAT explains. The company would get the extra data Medicare wants, but not through the slow, traditional trials the agency is proposing. Instead, Biogen would focus on the speedier process of gathering real-world evidence about the treatment. In comments filed with Medicare, Biogen argued it cannot obtain that wider dataset if its drug is only available for such a limited patient population. The company also hinted it could sue the government if the Medicare proposal advances.
Create a display name to comment
This name will appear with your comment