J&J will be talking to FDA regarding expanded approval for peripheral arterial disease and coronary artery disease following early stop of COMPASS outcomes study; strong data will be needed if asymptomatic patients are targeted.
The early termination of the Phase III COMPASS outcomes study of Johnson & Johnson/Bayer AG's Factor Xa inhibitor Xarelto opens the door for a new arterial disease indication that could mean a new chronic use and a competitive advantage over other novel anticoagulants, if the company succeeds in getting a label change.
Janssen Pharmaceuticals Inc. and partner Bayer, which markets the drug outside the US, announced Feb. 8 that Xarelto (rivaroxaban)...
Otsuka bested Vera on Phase III immunoglobulin A nephropathy data for proteinuria, but analysts wonder if the difference is especially meaningful.
The company presented Phase I data for CART-EGFR-IL13Rα2, showing patient responses in the notoriously hard-to-treat and deadly brain cancer.
The low-dose atropine eye drop slowed the progression of pediatric myopia by 30%.
Arvinas and Pfizer have just filed the potential first-in-class protein degrader vepdegestrant, but its diminished commercial prospects after mixed Phase III data mean Pfizer could exit.
IGI CEO tells Scrip about the “very encouraging” feedback at ASCO to promising early data for the firm's first-in-class investigational trispecific antibody in multiple myeloma. Is a licensing deal in the offing?
Once-daily oral FASN inhibitor denifanstat meets all endpoints in a Chinese Phase III trial for moderate-to-severe acne, paving the way for a regulatory submission in China.
Regenxbio reported functional and biomarker data from an ongoing study of RGX-202, which it hopes to file for approval in Duchenne muscular dystrophy in 2026.
