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NEWS

Johnson & Johnson’s Tremfya (Guselkumab) Receives the US FDA’s Approval for Pediatric Plaque Psoriasis and Active Psoriatic Arthritis

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 labelPlaque PsO approval was based…
September 30, 2025

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NEWS

Sun Pharma Reports Topline Data from P-III (INSPIRE-1 & INSPIRE-2) Trials of Ilumya (Tildrakizumab) for Active Psoriatic Arthritis

Shots:Sun Pharma has reported topline data from P-III (INSPIRE-1 & INSPIRE-2) trials assessing Ilumya (100mg) in pts with active psoriatic arthritis (PsA)INSPIRE-1 & INSPIRE-2 trials to evaluate Ilumya (Q12W) vs PBO in ~800 active PsA pts over 52wks., where INSPIRE-1 enrolled pts with prior anti-TNF exposure & INSPIRE-2 enrolled anti-TNF naïve ptsBoth…
July 21, 2025

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Key Biosimilars Events of September 2024
INSIGHTS+

Key Biosimilars Events of September 2024

Shots:      Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency       Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients       The major highlights were the US FDA’s approval of Samsung Bioepis and…
October 3, 2024

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NEWS

Rani Therapeutics Reports the Results for RT-111 Capsules Containing CT-P43 (biosimilar, ustekinumab) in P-I Trial for the Treatment of Various Indications

Shots:  The P-I clinical trial evaluates the safety & efficacy of RT-111 in delivering CT-P43 (biosimilar, ustekinumab) in patients with moderate to severe plaque psoriasis, active psoriatic arthritis & IBD As per the results, RT-111 delivered CT-P43 in a dose proportional manner with high bioavailability & depicted a higher Cmax & shorter Tmax vs ustekinumab…
February 3, 2024

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Insights+ Key Biosimilars Events of November 2023
INSIGHTS+

Insights+ Key Biosimilars Events of November 2023

Shots:Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency  Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients  During November, Amgen received US FDA approval for Wezlana, biosimilar of ustekinumab &…
December 6, 2023

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PharmaShots Interview Janssen’s Soumya D. Chakravarty Shares Insights on Tremfya (guselkumab) for the Treatment of Active Psoriatic Arthritis
VIEWPOINTS

PharmaShots Interview: Janssen’s Soumya D. Chakravarty Shares Insights on Tremfya (guselkumab) for the Treatment of Active Psoriatic Arthritis

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 DiseasesThe P-IIIb (COSMOS) trial evaluates Tremfya (100mg) vs PBO in a ratio (2:1) in 285 patients with active PsA…
April 25, 2022

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