Shots:
J&J has reported 96wk. P-III trial data in mod. to sev. Crohn’s Disease incl. GRAVITI (SC induction: 400mg Q4W; maintenance: 200mg at Wk. 12 then Q4W or 100mg at Wk. 16 then Q8W) vs PBO, & GALAXI 2 & 3 (IV induction: 200mg Q4W; SC maintenance) vs Stelara
In GRAVITI, 92% (100mg) & 93.4%…
Shots:
J&J has reported P-III (ASTRO) trial data assessing Tremfya SC induction (400mg at Wks. 0, 4 & 8) followed by maintenance dose of either Tremfya 100mg (SC, Q8W) or 200mg (SC, Q4W) vs PBO in adults (n=418) with mod. to sev. active UC
At Wk. 48, trial showed improved clinical remission rates of 36.7%…
Shots:
FDA has approved Tremfya (SC; Wk. 0, 4 & then Q8W) for children (≥6yrs.; ≥40kg) with mod. to sev. plaque PsO, who are candidates for systemic therapy or phototherapy, or active PsA; an FDA application was also filed to add joint damage inhibition in active PsA adults to Tremfya’s label
Plaque PsO approval was based…
Shots:
Polpharma has entered into licensing deals with MS Pharma to commercialize PB016 (vedolizumab), PB018 (ocrelizumab), & PB019 (guselkumab) biosimilars across the Middle East & North Africa (MENA) region
As per the deal, MS Pharma will be responsible for registration, marketing, & distribution of the 3 biosimilars in MENA, while Polpharma will handle development, manufacturing,…
In an interview with PharmaShots, Soumya D. Chakravarty, Senior Director, Strategic Lead, Rheumatology Therapeutic Area at Janssen shared his views on the data of Tremfya in the P-IIIb (COSMOS) trial for the treatment of active psoriatic arthritis, published in the Annals of the Rheumatic Diseases
The P-IIIb (COSMOS) trial evaluates Tremfya (100mg) vs PBO in a ratio (2:1) in 285 patients with active PsA…
In an interview with PharmaShots, Alyssa Johnsen, MD, Ph.D., Vice President, Rheumatology and Maternal-Fetal Health Disease Area Leader at Janssen Research & Development shares her views on the P-III DISCOVER-1 & 2 Studies of Tremfya (guselkumab) for the treatment of psoriatic arthritis in ACR 2021 and published in Arthritis & Rheumatology
Shots:
The P-III DISCOVER-1 & 2 trials evaluate Tremfya (SC) vs PBO in 381 & 739…
In an interview with PharmaShots, Dr. Philip Mease, MD, Seattle Rheumatology Associates shares insights on the P-III DISCOVER-1 & 2 Studies of Tremfya (guselkumab) for the treatment of psoriatic arthritis in The Lancet Rheumatology
Shots:
The P-III trials consist of two studies i.e., DISCOVER-1 & 2 evaluates Tremfya in 1100 patients with PsA who have axial symptoms
The results demonstrated efficacy…

