Novartis AG won FDA clearance for the anti-CD20 monoclonal antibody Kesimpta (ofatumumab) in relapsing forms of multiple sclerosis (MS) in adults, with a label that includes clinically isolated syndrome and relapsing-remitting as well as active secondary progressive disease.
Sanofi SA is acquiring Principia Biopharma Inc. in a $3.68 billion deal that brings Sanofi three clinical-stage BTK inhibitors and simplifies a partnership that began three years ago. Paris-based Sanofi plans to acquire all outstanding Principia common stock shares for $100 each at a $3.36 billion enterprise value. Sanofi will get SAR-442168 (PRN-2246), the brain-penetrant candidate at the heart of the deal. The agreement now gives Sanofi full control of the program, bringing a three-year partnership between the two companies to an end
The FDA’s go-ahead for Roche Holding AG’s Enspryng (satralizumab-mwge) in anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder had watchers of the space weighing its market odds against two therapies approved earlier: Soliris (eculizumab) from Boston-based Alexion Pharmaceuticals Inc., and the more recently cleared Uplizna (inebilizumab-cdon) from Viela Bio Inc., of Gaithersburg, Md.