Despite a troubled history of JAK inhibitors in lupus trials, AbbVie’s Rinvoq has hit the mark in a mid-stage study of the condition, shifting focus to a pivotal program that could expand the blockbuster drug’s reach.

Following the FDA’s release of draft guidance to enhance patient voice, In Vivo spoke with Ipsen’s rare disease regulation expert on creating a more patient-centric R&D and approval pathway, from modified endpoints to trial decentralization and beyond.

The US firm’s drug for schizophrenia- and bipolar-related agitation Igalmi has failed part one of a pivotal trial in at-home patients, but the option for higher dosing in part two combined with placebo-like safety could offer hope.

The US firm’s kinase inhibitor fell short of overall survival expectations in combination with a PD-1 inhibitor in an advanced lung cancer trial, but upcoming milestones for Krazati may be more of a concern.

The Swiss firm’s lead candidate has hit the mark in the first stage of a pivotal diabetic macular edema program, edging closer to becoming the first eye drop treatment for a condition where unmet need remains despite the advent of anti-VEGFs.

The IL-4/IL-3 inhibitor attained a greater reduction in exacerbations in patients with a higher level of a biomarker for type 2 inflammation according to complete pivotal data, but questions remain on the timing of regulatory filings.