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.
The U.S. FDA has approved its first pharma treatment in more than 40 years for motion sickness. The green light for Nereus (tradipitant), from Vanda Pharmaceuticals Inc., was based on three clinical studies, all pivotal, including two phase III real-world trials with patients on boats and another supporting study.
Two Flagship Pioneering Inc. biopharma companies founded in the last five years and focused on proteomic and genomic technologies entered agreements to help discover new therapeutics for respiratory and liver diseases under a framework collaboration with GSK plc. Under that agreement, Profound Therapeutics Inc. and Quotient Therapeutics Inc. would use their platform technologies to discover novel proteins and targets for developing drugs to treat chronic obstructive pulmonary disease and idiopathic pulmonary fibrosis, with Quotient taking on a third indication with metabolic dysfunction-associated steatohepatitis.
The U.K. Medicines and Healthcare products Regulatory Agency is calling for unified standards to harmonize microbiome research, after revealing major inconsistencies in the results when labs around the world analyzed identical reference samples of gut bacteria.
Growth factor specialist Agomab Therapeutics NV is now preparing to move into phase IIb development after delivering positive phase IIa results for its lead program, ontunisertib, an orally available treatment for fibrostenosing Crohn’s disease.
Top-line results from a midstage study of Vanda Pharmaceuticals Inc.’s tradipitant hit its primary endpoint by preventing the nausea and vomiting that can be caused by the GLP-1 receptor agonist Wegovy (tirzepatide, Eli Lilly and Co.) in overweight and obese adults. The positive phase II study data prompted Vanda to look at a phase III study of the oral neurokinin-1 receptor antagonist next year.
South Korean researchers led by Lee In-suk of Yonsei University have reported the most complete oral microbiome catalog to date, with more than 72,000 genomes. Detailed in Cell Host & Microbe on Nov. 12, 2025, the database is expected to serve as a universal platform for academia and enable “precision microbiome medicine” for the industry, Lee told BioWorld.
Phase II data being presented at the American Association for the Study of Liver Diseases annual meeting indicate drug development in the field of metabolic dysfunction-associated steatohepatitis (MASH) is making steady progress.
A paper last month in the Journal of Clinical Oncology reported on the pooled analysis of data showing that the use of neoadjuvant immune checkpoint inhibitors work better than the frequently used FLOT regimen (fluorouracil, leucovorin, oxaliplatin and docetaxel) in certain gastroesophageal adenocarcinoma (GEA) cancers. But there’s plenty more coming down the pike, even as scientific knowledge about the disease advances.