Lawmakers ramp up probe of FDA approval of Biogen drug – STAT

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 is rather modest. We plan to spend time promenading with the official mascot, manicure the Pharmalot campus grounds, and have a listening party with Mrs. Pharmalot. And what about you? This remains a fine time to enjoy the great outdoors — remember, beaches and lakes are beckoning. You could catch up on your reading. Or make plans with someone special. Well, whatever you do, have a grand time. But be safe. By the way, there is an extended break on this side of the pond, after which we will hit the proverbial pause button to observe ancient rituals, so a colleague will fill in for us. Meanwhile, enjoy and see you next year. …

House lawmakers have requested data and documents from the Food and Drug Administration related to the agency’s controversial accelerated approval of Biogen’s (BIIB) new Alzheimer’s drug, STAT writes. The House committees have already requested documents from Biogen, but this is the first public request by congressional investigators directly to the agency. The request cites a STAT story that revealed Biogen had an off-the-books meeting with a key FDA regulator ahead of the approval last June.

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