Tags : Expanded Use

Janssen Receives EC’s Approval for the Expanded Use of Stelara

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 study follows its prior P-III CADMUS study The P-III CADMUS Jr study results: @12wks. improvement in psoriasis and HrQOL; patients achieved PGA 0/1 (77.3%); PASI […]Read More

Chugai Receives MHLW’s Approval for the Expanded Use of FoundationOne

Shots: The MHLW has approved the expanded use of FoundationOne CDx for Rozlytrek to treat ROS1 fusion-positive, LA/ m-NSCLC, allowing the physician to identify NSCLC patients who could benefit from Rozlytrek by detecting ROS1 fusion genes On Mar 15, 2019, Chugai has filed an application for the additional indication of Rozlytrek. Chugai will further expand […]Read More

Janssen’s Stelara (ustekinumab) Receives EC’s Approval for its Expanded Use

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. to sev. active UC with inadequate response to conventional (corticosteroids, immunomodulators) or biologic (one or more TNF-alpha antagonists/vedolizumab) therapies Induction study results: Clinical response achievement […]Read More