The FDA held a public forum on Monday to discuss the future of psychedelic therapeutics, followed by a meeting on Wednesday regarding recommendations for reauthorizing the Prescription Drug User Fee Act the day after launching its TrialBlazer initiative. Meanwhile, Definium Therapeutics notched another late-stage trial win for its LSD drug, and Novartis continues to reel from the company’s triple asset stumble.
The FDA is making its presence known this week, with two highly anticipated public meetings: one, on Monday, focused on the near-term future of psychedelic drug development as Compass Pathways and Definium Therapeutics inch ever closer to approval; the second, on Wednesday, to discuss recommendations for reauthorizing the Prescription Drug User Fee Act. A busy first week for Michael Davis and Karim Mikhail in their newly permanent roles as directors of the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
Before Monday’s meeting, Definium reported topline data from a third successful Phase 3 trial of its oral LSD drug—and the second in generalized anxiety disorder, paving the way for an FDA bid in this indication, according to analysts. And teeing up Wednesday’s PDUFAIII forum, the FDA opened applications for its expedited investigational new drug program, dubbed Operation TrialBlazer.
Meanwhile, several biopharma companies—including Summit Therapeutics, BioNTech, GSK and Roche—showed off positive survival data for their lung cancer hopefuls at the World Conference on Lung Cancer in South Korea.
And on the business side of biopharma, Novartis’ recent triple asset stumble knocked shares of the Swiss drugmaker down by 13% last week and dragged down some of its peer companies with it.
Finally, Novo Nordisk is no more. The company introduced its new moniker this week—simply “Novo”—and flipped it iconic bull to face the right in a corporate rebrand.
