Ep. 244 - Leqembi's Thumbs-Down in Europe. Plus: Perioperative Cancer, Pediatric Review Vouchers
Europe’s CHMP has again ruled in contrast to FDA for a neurology product, this time on Biogen and Eisai’s Leqembi for Alzheimer’s disease. On the latest BioCentury This Week podcast, BioCentury editors discuss the similarities and differences between Leqembi lecenamab and Aduhelm aducanumab, the first anti-amyloid mAb from Biogen and Eisai and what it means for the next in line from that class, Kisunia donanemab from Eli Lilly. The editors also break down last week’s ODAC meeting, which discussed trials in perioperative cancer for checkpoint inhibitors, and talk about the looming delay in reauthorization of the rare pediatric priority review voucher program. They also assess the implications of the investigation by the House Select Committee on the Chinese Communist Party into clinical trials run in Chinese military hospitals and the Xinjiang Uyghur Autonomous region, a story broken last week by Washington Editor Steve Usdin.
View full story: https://www.biocentury.com/article/653010
02:06 - CHMP Leqembi Decision
09:53 - Perioperative Cancer
17:45 - Pediatric Review Vouchers
23:55 - Beyond Biosecure
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