Tags : guselkumab

Janssen Reports Results of Tremfya (guselkumab) in Interim Analysis of

Shots: The P-II GALAXI 1 study involves assessing of Tremfya vs PBO in patients with mod. to severely active CD with intolerance to conventional therapies. In interim analyses, patients were randomized equally into 5 arms, with Tremfya (200/600/1200 mg (IV) @0, 4 & 8wks. respectively or with ustekinumab, dosed at ~6mg/kg (IV) @0wk. and dosed […]Read More

Janssen Reports Submission of sBLA to the US FDA for

Shots: The sBLA is based on two P-III DISCOVER-1 & 2 studies assessing Tremfya (SC) in 381 & 739 patients with active PsA including prior treated patients with anti-TNF therapy and continued through 52wks. & biologic-naïve patients planning to continue through 100wks. respectively The P-III DISCOVER-1 & 2 studies resulted in meeting their 1EPs i.e, […]Read More

Janssen Expands Clinical Development for Tremfya(R) (guselkumab) in Familial Adenomatous

Shots: Janssen has initiated P-Ib proof-of-concept clinical trial assessing Guselkumab vs PBO in 72 patients with familial adenomatous polyposis (FAP). With the initiation of P-Ib study for FAP, MorphoSys will receive milestones from Janssen Earlier, Janssen collaborated with MorphoSys to develop Guselkumab utilizing MorphoSys’s HuCAL antibody technology (Human Combinatorial Antibody Library), a platform for invitro […]Read More