US FDA will continue to tie orphan exclusivity to uses or indications for which the drug was approved. Attorneys say this buys agency time to sort out complex policy and legal questions and continue to seek legislative fix. Additional litigation is also possible, as happened in Depomed case.

The Danish group has cut 300 jobs to shift to an external innovation sourcing model that will make Leo more competitive in the dermatology space and help it break even this year, CEO Christophe Bourdon tells Scrip.

Public Company Edition: Also, Johnson & Johnson’s consumer health spin-out Kenvue filed paperwork to get the ball rolling on an initial public offering. In addition, Geron raised $198m and Madrigal accessed more than $300m after positive trial readouts, but layoffs were revealed by Editas, Elevation, Nabriva and others.

Scrip takes a look at key recent drug development activities in the NASH area by Korean firms, which are now pursuing the global development of their candidates as they look to leverage innovation to expand internationally.