Accord BioPharma Reports the US FDA Approval of Immgolis and Immgolis Intri (Biosimilar, Simponi and Simponi Aria)

Shots: The US FDA has approved Immgolis & Immgolis Intri, the interchangeable biosimilar versions of Simponi & Simponi Aria (golimumab), respectively Immgolis & Immgolis Intri are both approved for the treatment of adults with mod. to sev. active rheumatoid arthritis in combination with methotrexate, while Immgolis is additionally approved for mod. to sev. active ulcerative…

ByRidhi Rastogi2 days ago

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Earendil Labs Doses First Patient with HXN-1001 in P-IIa Trial in Ulcerative Colitis

Shots: Earendil Labs has dosed the first patient with HXN-1001 in the P-IIa trial, & completed enrolment of healthy subjects in the P-I trial across Australia The P-IIa trial will assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of HXN-1001 vs PBO in ulcerative colitis patients HXN-1001 is a half-life extended anti-TL1A antibody…

ByRidhi RastogiApril 3, 2026

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Takeda Reports Positive P-III (KEPLER) Results of Entyvio in Pediatric Ulcerative Colitis

Shots: Takeda reported positive data from the global P-III (KEPLER) study evaluating IV ENTYVIO (vedolizumab) in children and adolescents (ages 2–17) with moderate to severe ulcerative colitis (UC) who had inadequate response to conventional therapies and/or TNF antagonists Nearly half (47.3%) of pts achieved the 1EP of clinical remission at Wk. 54, while 34.7% achieved…

ByPrince GiriFebruary 20, 2026

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Teva and Sanofi Report P-IIb (RELIEVE UCCD) LTE Study Data on Duvakitug in Inflammatory Bowel Disease

Shots: Teva & Sanofi have reported RELIEVE UCCD LTE study data evaluating duvakitug (450 or 900mg, SC, Q4W) in 130 pts with ulcerative colitis (UC) or Crohn’s disease (CD) following P-IIb (RELIEVE UCCD) induction study Trial showed that at Wk. 44 of maintenance, 58% (900mg) & 47% (450mg) of UC pts achieved clinical remission per mMS,…

ByRidhi RastogiFebruary 17, 2026

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Takeda Reports Topline P-III (LATITUDE) Trials Findings on Zasocitinib in Plaque Psoriasis (PsO)

Shots: Takeda has reported data from 2 global P-III trials (NCT06088043 & NCT06108544) assessing zasocitinib (TAK-279) vs apremilast & PBO in 693 & 1108 adult pts, respectively, with mod. to sev. PsO Trial showed superiority to PBO on co-1EPs (sPGA 0/1 & PASI 75) at Wk. 16, with early PASI 75 responses from Wk. 4, sustained…

ByRidhi RastogiDecember 18, 2025

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Alvotech and Advanz Pharma’s Gobivaz (Biosimilar, Simponi) Receives the EC Approval to Treat Several Chronic Inflammatory Diseases

Shots: The EC has approved Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis (with methotrexate), PsA (± methotrexate), ankylosing spondylitis & ulcerative colitis in adult pts & juvenile idiopathic arthritis (with methotrexate) across 30 EEA states Approval was based on extensive data, incl.…

ByRidhi RastogiNovember 20, 2025

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Alvotech & Advanz Pharma’s Gobivaz (Biosimilar, Simponi) Receives the MHRA’s Approval to Treat Several Chronic Inflammatory Diseases

Shots: The UK’s MHRA has approved Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis, PsA, axial spondylarthritis & ulcerative colitis in adult pts & juvenile idiopathic arthritis, following CHMP’s positive opinion Additionally, Alvotech is responsible for the development & commercial supply of Gobivaz, while…

ByRidhi RastogiNovember 7, 2025

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Eli Lilly’s Omvoh (mirikizumab-mrkz) Receives the US FDA’s Approval for Ulcerative Colitis

Shots: The US FDA has approved Omvoh (200mg/2mL, SC, QM) as a maintenance treatment of adults with mod. to sev. active ulcerative colitis; PFS & prefilled pen to be available in early 2026 Approval was based on P-I trial assessing Omvoh (200mg/2mL, SC) single injection vs 2 100mg/1mL injections in participants, which showed bioequivalence between the…

ByDipanshu DixitOctober 28, 2025

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Johnson & Johnson Reports P-III (ASTRO) Trial Data of SC Tremfya (Guselkumab) for Ulcerative Colitis (UC)

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%…

ByRidhi RastogiOctober 9, 2025

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Eli Lilly Reports P-III (LUCENT-3) OLE Trial Data of Omvoh to Treat Ulcerative Colitis

Shots: Eli Lilly has reported long-term data from the P-III (LUCENT-3) OLE study of P-III (LUCENT-1 & LUCENT-2) trials, evaluating the efficacy & safety of Omvoh (mirikizumab-mrkz) in mod. to sev. active ulcerative colitis pts over an additional 3yrs., totaling ~4yrs. of treatment In LUCENT-3, among pts who achieved clinical remission with Omvoh at 1yr.…

ByRidhi RastogiOctober 8, 2025

Accord BioPharma Reports the US FDA Approval of Immgolis and Immgolis Intri (Biosimilar, Simponi and Simponi Aria)

Earendil Labs Doses First Patient with HXN-1001 in P-IIa Trial in Ulcerative Colitis

Takeda Reports Positive P-III (KEPLER) Results of Entyvio in Pediatric Ulcerative Colitis

Teva and Sanofi Report P-IIb (RELIEVE UCCD) LTE Study Data on Duvakitug in Inflammatory Bowel Disease

Takeda Reports Topline P-III (LATITUDE) Trials Findings on Zasocitinib in Plaque Psoriasis (PsO)

Alvotech and Advanz Pharma’s Gobivaz (Biosimilar, Simponi) Receives the EC Approval to Treat Several Chronic Inflammatory Diseases

Alvotech & Advanz Pharma’s Gobivaz (Biosimilar, Simponi) Receives the MHRA’s Approval to Treat Several Chronic Inflammatory Diseases

Eli Lilly’s Omvoh (mirikizumab-mrkz) Receives the US FDA’s Approval for Ulcerative Colitis

Johnson & Johnson Reports P-III (ASTRO) Trial Data of SC Tremfya (Guselkumab) for Ulcerative Colitis (UC)

Eli Lilly Reports P-III (LUCENT-3) OLE Trial Data of Omvoh to Treat Ulcerative Colitis

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