Everyone knows that mice aren’t men. Yet animal studies still form the basis of most biomedical research, even as their value is hotly debated. But exactly how often do therapies that start in animals translate to the clinic?

The unveiling of Johnson & Johnson’s full data from the phase 2 trial of nipocalimab in Sjögren’s disease (SjD) suggest that both the Big Pharma and its competitor argenx are on the right track by targeting FcRn antagonism at the automimmune disorder, according to analysts.

The FDA is joining hands with regulators in Canada and the U.K. on policies to ensure transparency in the development of medical devices powered by machine learning.

Cabaletta Bio’s shares tumbled 13% Friday morning as the biotech shared just a crumb of data from two patients in an autoimmune CAR-T trial that hinted at remission.

Innovent Biologics’ bispecific immuno-oncology candidate IBI363 has been linked to a 100% response rate in a small cohort of Chinese lung cancer patients.

The FDA has elevated a recall from Medline that has seen the device distributor pull tens of thousands of endotracheal tubes from use.

Ultragenyx Pharmaceutical’s work to get the FDA to recognize a biomarker as a surrogate endpoint looks to have paid off. With the agency agreeing the biomarker is a reasonable surrogate endpoint, Ultragenyx is preparing to file for approval of its Sanfilippo syndrome gene therapy around the end of the year.

Pfizer’s phase 3 gene therapy trial has failed to demonstrate significant improvement in motor function for boys with Duchenne muscular dystrophy (DMD).

Invizius has completed a first-in-human study of its approach to taming the immune system’s overreaction to dialysis—with the goal of addressing the complications that can come with “angry blood.”

Abbvie, Merck, Roche, Genentech, Regeneron, Sanofi and other big names in biopharma have signed on to a new project from the Digital Medicine Society’s (DiMe) Digital Health Measurement Collaborative Community (DATAcc) that aims to set industry benchmarks for digital technologies.