The concept of the 3 Rs – reducing, refining and replacing animal research – has been championed since the 1950s, when William Russel and Rex Burch argued in their book “The Principles of Humane Experimental Technique” that the 3 Rs could simultaneously improve the treatment of research animals and advance the quality of scientific and medical research and testing. Current standard practices of animal research undeniably cause animal suffering at the same time that they have prioritized replicability over translatability.
Just a few weeks after reporting positive data with izicopan (INF-904) in hidradenitis suppurativa and chronic spontaneous urticaria, Inflarx NV is putting most of its chips on the oral complement C5a receptor inhibitor going forward.
The U.S. FDA signaled during a Type B meeting that existing data could support a BLA filing for Moonlake Immunotherapeutics AG’s sonelokimab to treat the skin disease hidradenitis suppurativa (HS), despite one of two pivotal phase III trials missing the mark.
Debate over Vanda Pharmaceuticals Inc.’s Hetlioz (tasimelteon) for use in jet lag disorder looks to continue after the U.S. FDA rejected the latest supplemental NDA submission, with the agency’s Center for Drug Evaluation and Research concluding the application cannot be approved in its current form.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Akeso, Arrowhead, Curadel, GSK, Vivavision.
Clinical updates, including data readouts and publications: Bridgebio, Genfit, Gilgamesh, GSK, Hutchmed, Jazz, JJP Biologics, Monte Rosa, Pulmocide, Rezolute.
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