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 still coming together. We plan to catch up on our reading, spend time with one of the short people and observe an ancient ritual. We also hope to hold an invigorating listening party, where the rotation will likely include this, this, this, this and this. And what about you? Once again, we will remind you that the holidays are quickly approaching, so stimulate the economy now and indulge those closest to you with a nice gift or two. Besides, you never know where inflation is headed. And there is surge pricing to consider, too. If all this is too much, you could simply enjoy the great outdoors by taking a ride in the country or a brisk walk along city streets. Or maybe binge watch something on the telly. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon…
In her nine months as scientific adviser to U.S. Food and Drug Administration Commissioner Marty Makary, Tracy Beth Høeg’s track record has raised questions about her ability to oversee drug regulation without bias, STAT tells us. The concerns come as she is poised to become acting director of the FDA Center for Drug Evaluation and Research. Already, Høeg has taken steps to limit access to Covid shots, cut career staff out of vaccine surveillance research and revisit the safety of monoclonal antibodies that protect infants against RSV. She has spoken at length about the risks of certain antidepressants for pregnant people without considering the benefits, and advised the U.S. Centers for Disease Control and Prevention to cut down its childhood vaccine schedule. She is seeking radical change, often based on thin evidence.
Leaders at the U.S. Food and Drug Administration have pressed internally for reviewers to speed up their evaluation of Eli Lilly’s experimental weight loss pill, after the company pushed for a faster timeline, Reuters reports. The FDA Commissioner’s Office has said it wants to cut the time reviewers spend checking whether drug applications have enough material from 60 days to one week for Lilly’s pill and other medicines under a new, speedy review pathway, according to internal documents. After internal pushback, the Commissioner’s Office said it may cut those filing reviews to two or three weeks based on the application’s complexity, though it is not clear whether any change was likely to be implemented. If adopted, a new timeline could deliver Lilly a verdict on its pill by as early as March 28, ahead of the May 20 deadline reviewers had set.
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STAT Pharma: The science and business of new drug development
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