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Bringing Lupus Care Closer to Patients: Caterina Brindicci on AstraZeneca’s Next Chapter in Immunology

Shots:  AstraZeneca’s patient-focused immunology vision is reinforced by the EU approval of subcutaneous, self-administered Saphnelo (anifrolimab), offering people with SLE a more convenient option that reduces treatment burden, supports earlier biologic use, and advances the goal of remission beyond symptom control  The new formulation is expected to improve access, uptake, and adherence while easing infusion capacity constraints, with regulatory…

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Roche

Roche Receives the Health Canada Approval for Gazyva to Treat Active Lupus Nephritis

Shots: Health Canada has approved Gazyva (obinutuzumab) for adults with active lupus nephritis receiving standard therapy Approval was based on P-II (NOBILITY) & P-III (REGENCY) trials, where in REGENCY (n=271), 46.4% on Gazyva + SoC achieved CRR vs 33.1% on SoC. Gazyva’s safety profile was consistent with its well-established profile from haematology-oncology indications Gazyva is…

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Junshi Biosciences Reports NMPA Acceptance of the NDA for Roconkibart (IL-17A) to Treat Moderate to Severe Plaque Psoriasis

Shots: Junshi Biosciences reported that the NMPA has accepted the NDA for roconkibart injection (JS005), for adults with moderate to severe plaque psoriasis eligible for systemic therapy or phototherapy The submission is backed by a multicenter P-III study (n=747) showing significant improvements in PASI 75/90/100 and sPGA 0/1 vs PBO at 12wks., with sustained efficacy…

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Repertoire Immune Medicines & Genentech

Repertoire Immune Medicines Collaborates with Genentech to Develop T cell-Targeted Therapies for an Autoimmune Disease

Shots: Repertoire & Genentech have entered into a collaboration & license agreement to identify & develop novel T cell-targeted therapies for an autoimmune disease, leveraging Repertoire’s DECODE platform As per the deal, Genentech will handle preclinical & clinical development along with global marketing in exchange for $35M upfront & ~$730M in development, regulatory & commercial…

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Disease of the Month – Sjögren’s Syndrome

Disease of the Month – Sjögren’s Syndrome

Shots:  A rare autoimmune condition, Sjögren’s Syndrome is characterized by dry mouth and eye. The condition affects 0.5 to 1% of the global population of which 90% of patients are women  In this reprise of our Disease of the Month report, we bring an illuminating account of Sjögren’s Syndrome with deep dive analysis of epidemiology, market size, disease management, available therapies, patient…

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Viewpoints_Dr. Murat Kalayoglu

PharmaShots Interview: Cartesian Therapeutics’s Dr. Murat Kalayoglu Shares Insight on RNA Cell Therapy for an Autoimmune Disease

In an interview with PharmaShots, Dr. Murat Kalayoglu, MD, Ph.D., President, and Chief Executive Officer at Cartesian Therapeutics shared his insights on the P-I/IIa study of Descartes-08 for the treatment of the chronic autoimmune disorder generalized myasthenia gravis (gMG) Shots: Descartes-08 is an autologous T-cell product that is engineered with RNA to encode for CAR The company focuses to use…

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