STAT+: Pharmalittle: Woodcock to retire from the FDA; Acrotech urged to speed up confirmatory study of cancer drugs
A FDA advisory panel urged Acrotech Biopharma to accelerate the release of trial data that could confirm benefits of its blood cancer drugs.
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. Besides the usual promenading with the official mascots, we hope to catch up on our reading and manicure the Pharmalot grounds. We may also have time for a listening party with a rotation that would likely include this, this, this, and this. And what about you? With a few holidays around the corner, this may be a good time to thumb through catalogs or visit a temple of consumption. You could make plans to visit someone special. Or contemplate the rest of your life. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …
A U.S. Food and Drug Administration advisory panel urged Acrotech Biopharma to work with the agency to bring forward the date for releasing trial data that could confirm benefits of the company’s blood cancer drugs, Reuters tells us. The drugs, Folotyn and Beleodaq, have already been on the market for nearly a decade or more. They were approved under the FDA accelerated pathway in 2009 and 2014, respectively, for treating a rare form of blood cancer. The company’s final study plan was submitted to the FDA in 2022 and is expected to be completed by 2030, according to FDA briefing documents published earlier this week.
Janet Woodcock, the principal deputy director at the FDA, will retire early next year after helping steer the agency through a historic period of medical advances during nearly four decades in key leadership positions, STAT writes. It was under her leadership that the FDA became a modern, efficient regulator that helped industry attract capital, and she presided over a major expansion and modernization of the generic drug program and crafted the reform of over-the-counter drug reviews. But her tenure was not without controversy. She helmed the agency during its controversial approval of the Alzheimer’s drug Aduhelm that overrode an FDA advisory panel.
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