Shots: The company has submitted an sBLA to the US FDA for an expanded approval of Stelara (ustekinumab) to treat pediatric patients ≥aged 5yrs. with jPsA The submission is based […]readmore
Tags : Stelara
In an interview with PharmaShots, Andrew Greenspan, VP, Immunology Affairs at Janssen shared his views on the new AGA guidelines on the medical management of moderate-to-severe Crohn’s disease and also […]readmore
In an interview with PharmaShots, Jan Wehkamp, M.D., Vice President, Disease Area Leader, Gastroenterology at Janssen Research & Development shared his views on the data regarding the safety & efficacy […]readmore
Shots: The company initiates P-III clinical trial to evaluate the efficacy, safety, tolerability, PK, and immunogenicity of SB17 vs Stelara in a ratio (1:1) in patients with moderate to severe […]readmore
Shots: The first patient has been dosed in a P-III clinical study evaluating the efficacy and safety of BAT2206 vs reference Stelara in ~ 472 patients with moderately to severely […]readmore
Shots: The P-III UNIFI study involves assessing the safety & efficacy of Stelara (90mg, q8w/q12w) as induction and maintenance therapy vs PBO in 588 patients with UC with inadequate response […]readmore
Shots: The company initiates the P-I study to evaluate the safety and tolerability of BFI-751 vs in 210 healthy volunteers and their immune response across Australia and New Zealand The […]readmore
Shots: The P-I clinical trial involves assessing of a single dose of either NeuLara, US- or EU-sourced Stelara in ~200 healthy volunteers. NeuLara is NeuClone’s second biosimilar to have met […]readmore
Shots: The P-lll IM-UNITI LTE study involves assessing of Stelara (SC, 90mg, q8w/q12w) vs PBO as maintenance therapy in 1,281 patients with moderate to severe CD. All patients completing 44wks. […]readmore
Shots: The first patient has been dosed in a P-I clinical study to compare the PK and safety of BAT2206, a proposed biosimilar to Stelara (ustekinumab) to US/EU-sourced reference product […]readmore