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
Tags : (ustekinumab)
Shots: The EC’s approval is based on P-III CADMUS Jr study assessing Stelara (SC) in 44 pediatric patients with mod. to sev. PsO aged 6–11 yrs. from 9 countries. The […]readmore
Shots: The P-I trial involves assessing of Stelara (US or EU) vs NeuLara in 210 patients in ratio (1:1:1) and resulted in no serious adverse events with anticipated results in […]readmore
Shots: The P-I trial involves assessing of DMB-3115 vs reference products (US- and EU-marketed products under the name of Stelara) in healthy volunteers to evaluate its safety, PK and tolerability […]readmore
Shots: Bio-Thera to initiate P-I study to evaluate the PK and safety study of BAT2206 (proposed biosimilar) vs Janssen’s Stelara (ustekinumab) US & EU-sourced in normal healthy candidates The clinical […]readmore
Shots: Australian Therapeutic Goods Administration (TGA) Clinical Trial Notification (CTN) scheme is responsible for conducting the NeuLara P-I trial and is being conducted across 200 healthy volunteers assessing PK and […]readmore
The P-I study involves assessing of FYB202 vs Stelara in patients evaluating the PK, safety, and tolerability while their dosing has been started last week Bioeq GmbH to sponsor the […]readmore
Shots: The approval is based on P-III UNIFI studies (UNIFI-I & -M) assessing Stelara induction (6mg/kg, IV, for 8wks.) and maintenance therapy (90mg, SC, for 44wks.) vs PBO in patients […]readmore
Shots: The EC approval is based on P-III UNIFI program [induction study (8wks. IV) & maintenance study (44wks., SC, q8w & q12w)] assessing Stelara vs PBO in patients with mod. […]readmore
Shots: Neuclone plans for the onset of P-I clinical study for NeuLara, a Stelara’s biosimilar evaluating NeuLara vs the US & EU score of Stelara in healthy candidates in Australia […]readmore