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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 controlÂ
The new formulation is expected to improve access, uptake, and adherence while easing infusion capacity constraints, with regulatory…
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 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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The EC has approved Usymro (BAT2206), a biosimilar version of J&J’s Stelara (ustekinumab) for all indications of the reference product
In Oct 2024, Bio-Thera & Gedeon Richter entered a licensing & commercialization deal under which Bio-Thera will develop & manufacture Usymro, while Gedeon will commercialize it post-approval & MA Holder transfer in the EU,…
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…
There are tons of clinical trials taking place at this moment. It’s a nasty disease and it’s important to figure out different ways to diagnose it, treat it, and, if possible, prevent it. 2024 brings on innovations in this field.
It can probably shed light on how cancer can become more treatable and not such…
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…
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-08Â is an autologous T-cell product that is engineered with RNA to encode for CAR
The company focuses to use…

