Half of the FDA’s upcoming 2024 user fee goals target rare diseases, but highly prevalent conditions like uncomplicated urinary tract infections and atopic dermatitis are also up for agency action in the second half of the year.

A Pink Sheet analysis finds US approval preceded European Union clearance for 80% of products approved in both areas, but when EU approval came first, it beat the FDA by a median of 13 months. US-first approvals came close to six months before the EU.

VX-880 is the first iteration of a cell therapy strategy which Vertex believes can bring curative treatment for Type 1 diabetes, but competition in this field is building.

First clinical efficacy readouts from several biotech companies developing CAR-Ts for systemic lupus erythematosus will be unveiled at EULAR, though the level of competition may be unsustainable.