Immune Disorders

Deal Snapshot: Genentech will pay $40m up front and in the near term, with milestone fees of up to $900m-plus, to use COUR’s tolerogenic nanoparticle treatments in an undisclosed autoimmune disease.

Sanofi’s rilzabrutinib and Alvotech/Advanz Pharma’s golimumab (AVT05) are among five new entries on the European Medicines Agency’s latest monthly list of products for which marketing applications are currently under review. Both drugs are investigational and are yet to be approved anywhere in the world.

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.