Immune Disorders

In a competitive immunology landscape, Eli Lilly is looking for novel agents, oral formulations of injectables, and combination therapies that can optimize response and expand the patient pool.

Detailed results for CD40L inhibitor dapirolizumab pegol showed consistent improvements over time with meaningful gains over placebo across all endpoints in its first Phase III study.

Novel targets for managing inflammation hold the promise of greater efficacy and safety for diseases not widely viewed as inflammatory in nature.

The Spanish company's Lilly-partnered atopic dermatitis drug is enjoying a decent launch in Germany and in other European countries, "we are getting the price that we wanted," claims CEO Carlos Gallardo.

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.