Shots: Pharmapark to get exclusive rights to commercialize the therapy with a status of a local product & will be responsible for filing the report in Russia and other CIS […]readmore
Tags : ustekinumab
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
Shots: Bio-Thera to receive $20M up front and $130M as development and commercial milestones and will be responsible for the development, manufacturing, and supply of BAT2206 Hikma get exclusive rights […]readmore
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
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 first patient has been dosed in the comparative, confirmatory efficacy, and safety AVT04-GL-301 clinical study to evaluate AVT04 vs Stelara in ~ 530 patients with plaque psoriasis across […]readmore
Biosimilars
Clinical Trials
BioFactura Initiates P-I Study of BFI-751 (biosimilar, ustekinumab) in Australia
Shots: The company initiate a pivotal PK P-I clinical trial assessing the efficacy of BFI-751 vs Stelara in healthy human volunteers, with the authorization of Ethics Committees in both Australia […]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