Novartis updates Leqvio label; MS study recruiting, thyroid study not yet recruiting
Novartis posted a Leqvio label supplement, a Diovan recall, an ongoing MS real-world study, and a not-yet-recruiting thyroid cancer study.
Novartis had a routine week spanning a label update, a recall, and two observational studies at different stages.
- Leqvio (inclisiran sodium) label update: the FDA approved a labeling supplement (SUPPL 21) for the subcutaneous solution, with the new label document dated 20260825 and submission status marked approved as of 2026-08-19.1
- Diovan (valsartan) 160 mg recall: Novartis Pharmaceuticals Corporation initiated a Class II voluntary recall for reason "Failed Dissolution Specifications," covering Lot AV5913C with an expiry of 6/2027, distributed nationwide in the US.2
- Kesimpta vs Ocrevus in multiple sclerosis (observational, real-world): this study is recruiting, having actually started 2026-04-08, and aims to generate real-world evidence on clinical effectiveness and economic burden of ofatumumab versus ocrelizumab in US patients with multiple sclerosis, assessing annualized relapse rate, healthcare resource utilization, and healthcare costs.3 Estimated enrollment is 7466 participants.3
- Second-line therapy in radioiodine-refractory thyroid cancer (observational, not yet recruiting): the study is estimated to start 2026-10-08 and aims to assess patient characteristics and treatment patterns of second-line systematic therapies, including BRAF V600E mutation-guided dabrafenib plus trametinib and multi-targeted tyrosine kinase inhibitors, among Chinese adult patients with RAI-R DTC.4 Estimated enrollment is 200 participants.4
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.