Tags : Rheumatoid Arthritis

Gilead’s Jyseleca (filgotinib) Receives the MHLW’s Approval for Rheumatoid Arthritis

Shots: The approval is based on two clinical trials (P-III FINCH and P-II DARWIN) programs assessing Jyseleca in 3,500+ patients across a range of RA patient populations, including patients new to treatment and those who have demonstrated inadequate response to treatment with SOC including biologic DMARDs. Gilead and Eisai will jointly commercialize Jyseleca across Japan […]Read More

Gedeon Richter Signs an Asset Purchase Agreement with Mycenax for

Shots: Mycenax to get $5M upfront and will get $16.5M as total deal value in four installments. Richter to get exclusive WW rights to develop, manufacture and commercialize biosimilar tocilizumab The focus of the agreement is to bolster its rheumatology portfolio with addition of Mycenax’s candidate. The biosimilar tocilizumab assets comprise the cell lines, intellectual […]Read More

Cumberland Pharmaceuticals’ RediTrex (methotrexate) Injection Receives the US FDA’s Approval

Shots: The approval of RediTrex is done post no. of communications with the FDA and several amendments to the NDA submitted to the FDA in late 2018 Cumberland to launch two injectable methotrexate product lines within the US targeted to treat active rheumatoid arthritis, juvenile idiopathic arthritis, and severe psoriasis RediTrex (methotrexate) Injection is targeted […]Read More

AbbVie’s Rinvoq (Upadacitinib) Receives CHMP Positive Opinion to Treat Moderate

Shots: The CHMP positive opinion is based on P-III SELECT program including SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE and SELECT-EARLY assessing Rinvoq in 4,400+ patients with mod. to sev. active RA In P-III studies, Rinvoq improved signs and symptoms of RA, inhibited radiographic progression and improved physical function, both as a monothx. and in combination with conventional […]Read More