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 Israeli firm’s third-quarter revenues and profits decreased as its product sales dipped due to alternative options and generic competition leading it to lower its full-year guidance, but its opioid crisis financial settlement remains on track.

With a new CEO at the helm, Gamida is closing in on an FDA approval, but a lack of cash could hobble its US launch efforts for allogeneic cell therapy product omidubicel.

Arcutis's CEO believes that with "a modest investment," the company can generate proof-of-concept data "against a de-risked target in a high-value indication,” Ducentis's preclinical atopic dermatits drug DS-234.