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Astrazeneca
NEWS

AstraZeneca Reports FDA Approval of Saphnelo for Systemic Lupus Erythematosus (SLE)

Shots: The US FDA has approved AstraZeneca’s Saphnelo pen (anifrolumab; 120mg, SC, QW, autoinjector) for the treatment of adults with SLE in combination with SoC Approval was based on the P-III (TULIP-SC) trial assessing Saphnelo pen vs PBO in 367 pts (18-70yrs.) with mod. to sev. SLE while receiving SoC, which showed Saphnelo reduced disease activity (1EP); full…
April 27, 2026

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VIEWPOINTS

Transforming Lupus Management: Caterina Brindicci Shares AstraZeneca’s Approach to Patient-Focused Care 

Shots:  TULIP-SC full results reinforce efficacy and remission potential with subcutaneous Saphnelo, showing higher disease activity reduction (56.2% vs 34% placebo at Week 52), improved BICLA response, DORIS-defined remission, and reduced oral corticosteroid use, consistent with the IV formulation  Self-administration expands access and adherence, offering flexible at-home or clinic dosing, supporting earlier biologic intervention and steroid…
February 18, 2026

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J&J
NEWS

Johnson & Johnson Reports Topline P-IIb (JASMINE) Trial Data on Imaavy (Nipocalimab) for Systemic Lupus Erythematosus (SLE)

Shots: J&J has reported the topline P-IIb (JASMINE) trial data assessing Imaavy (nipocalimab) vs PBO in 228 adults with SLE, along with the initiation of the P-III program Trial met its 1EP with higher SRI-4 composite response at Wk. 24, plus achieved secondary & exploratory endpoints, incl. those indicating the potential of nipocalimab for steroid sparing;…
January 7, 2026

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Astrazeneca
NEWS

AstraZeneca Reports EC Approval of Saphnelo for Systemic Lupus Erythematosus (SLE)

Shots: The EC has approved AstraZeneca’s Saphnelo (anifrolumab; 120mg, SC, QW, PFS) for the treatment of adults with SLE in combination with SoC; regulatory review is ongoing in the US & Japan Approval was based on the P-III (TULIP-SC) trial assessing Saphnelo vs PBO in 367 pts (18-70yrs.) with mod. to sev. active, autoantibody-positive SLE while receiving SoC,…
December 16, 2025

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Genentech
NEWS

Genentech Reports P-III (ALLEGORY) Trial Findings on Gazyva (Obinutuzumab) for Systemic Lupus Erythematosus (SLE)

Shots: Genentech has reported the P-III (ALLEGORY) trial data assessing Gazyva vs PBO in ~300 adults with SLE on SoC for 52wks. followed by ~104wks. OLE period Trial met its 1EP, with more participants achieving ≥4-point improvement in SRI-4 at 1yr., & achieved all key 2EPs, incl. improved BICLA response & a 6-point SRI-6 improvement at…
November 3, 2025

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Roche
NEWS

Roche Reports P-III (INShore) Trial Findings on Gazyva (Obinutuzumab) for Idiopathic Nephrotic Syndrome

Shots: Roche has reported the P-III (INShore) trial findings assessing Gazyva (Obinutuzumab; Wk. 0, 2, 24 & 26) vs mycophenolate mofetil (MMF; QD) in 85 pts (>2-25yrs.) with frequently relapsing or steroid-dependent nephrotic syndrome Trial met its 1EP, with more pts achieving sustained complete remission at 1yr., & certain 2EPs. Gazyva showed significant benefits in…
October 28, 2025

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NEWS

Hinge Bio Collaborates with Kyorin Pharmaceutical to Advance HB2198 in Japan for Autoimmune Diseases

Shots: Hinge Bio & Kyorin have entered into a collaboration & license agreement to develop HB2198 in Japan for various autoimmune diseases, starting with systemic lupus erythematosus (SLE), which is expected to enter trials by H2’25 As per the deal, Hinge will lead global HB2198 development & receive $10M upfront, ~$95M in SLE milestones, plus additional…
October 1, 2025

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Astrazeneca
NEWS

AstraZeneca Reports Interim P-III (TULIP-SC) Trial Data of Saphnelo for Systemic Lupus Erythematosus (SLE)

Shots: AstraZeneca has reported interim P-III (TULIP-SC) trial data assessing Saphnelo (anifrolumab; 120mg, SC, QW, accessorisedPFS) vs PBO in 367 pts (18-70yrs.) with mod. to sev. active, autoantibody-positive SLE while receiving SoC Interim analysis conducted after the first 220 pts reached Wk. 52, showed Saphnelo reduced disease activity (1EP), measured by BICLA at Wk. 52; data to be…
September 18, 2025

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