Immune Disorders

The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.

The College of American Pathologists wants a US district court to scrap the FDA’s final rule that unilaterally assumes oversight of lab-developed tests, but not because the college feels the agency has no business regulating them. Helena Duncan, senior director of quality at CAP, explained the college’s position to Medtech Insight.

With more advanced therapies gaining approval, companies at ARM’s Cell and Gene Meeting on the Mesa considered hurdles to making their products more broadly available and developing them for larger indications.

Nipocalimab is an investigational FcRn blocker for treating generalized myasthenia gravis that was also recently filed for regulatory review in the US.

The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.

Exosome-based treatments hold promise, but their reality has not yet materialized in the form of compelling clinical data. Belgian biotech Exo Biologics’ CEO Hugues Wallemacq believes his company can help move the field forward, both through its own clinical programs and by offering high-quality exosomes to others in the field.   

The clinical road has been pretty rocky for dapirolizumab pegol but a Phase III win is good news for the limited armamentarium of innovative treatments for lupus and a boost for Biogen’s hopes to expand its presence in immunology.

The Belgian drugmaker’s dual IL-17A and IL-17F inhibitor is now approved for four indications in the US, with another in hidradenitis suppurativa expected soon, and analysts believe that UCB’s peak sales forecast of €4bn could be on the conservative side.

While it waits to see if Fasenra succeeds in a Phase III trial for chronic obstructive pulmonary disease, the UK major has got over the regulatory line in the much smaller but underserved space of eosinophilic granulomatosis with polyangiitis.

The IL-13 inhibitor will go up against Regeneron/Sanofi’s Dupixent. Lilly executives talked to Scrip about the US launch.