Tags : Stelara

Janssen Reports Five-Year Data of Stelara (ustekinumab) in P-lll LTE

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. were eligible to enter the LTE program, continuing their current regimen ~252wks. 50%+ patients were randomized to q8w dosing and continued to receive this dosage […]Read More

Bio-Thera Initiates P-I Study of BAT2206 Proposed Biosimilar to Stelara

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 in healthy volunteers The company is expected to enroll 270 healthy volunteers. BAT2206 represents the fifth biosimilar of Bio-Thera’s portfolio that has advanced into clinical […]Read More

Top 20 Prescription Drugs Based on 2019 Revenue

The average life expectancy span of Human Beings are increased due to better medical facilities and drugs developed by Biopharma companies. Pharmaceutical products or drugs or medicines are being produced for a wide range of medical sectors. It includes the lifesaving drugs or the major therapy area including immunology, cardiology, and neurology but are they […]Read More

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

Bio-Thera Reports NMPA’s Acceptance of IND for BAT2206 Proposed Biosimilar

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 study will enroll ~ 270 healthy volunteers. The initiation of the study implies Bio-Thera’s commitment to develop & commercialize biosimilars for patients across the globe […]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