Regulatory roundup: Gilead, BMS seeking key approvals, plus news about AbbVie, Bavarian Nordic and more

A basket of regulatory news this week included submissions of closely watched products from Gilead and BMS, including the first-ever NDA for a candidate from Galapagos N.V. (Euronext:GLPG; NASDAQ:GLPG).

Gilead Sciences Inc. (NASDAQ:GILD) is seeking Priority Review of Janus kinase-1 (JAK-1) inhibitor filgotinib to treat rheumatoid arthritis, via the submission of a Priority Review voucher along with the candidate’s NDA. The potential blockbuster is part of a global collaboration between Gilead and Galapagos, and has previously been submitted for review by EU and Japanese regulators. The NDA’s submission triggers a $20 million milestone payment from Gilead to Galapagos (see “Threading the Needle”)...