ImvivaBio’s off-the-shelf CD19/BCMA CAR-T cell therapy CTA313 kept 88% of evaluable patients with refractory lupus in DORIS remission at Month 12, according to longer-term phase 1 data presented at ACR Convergence 2026.
|Articles|October 15, 2014
AbbVie Reconsiders Shire Offer
Author(s)BioPharm International Editors
AbbVie sends Shire notice that it is reconsidering its offer recommendation.
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Shire confirmed receipt of AbbVie’s notice of its consideration to either withdraw or modify its offer recommendation
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Full phase 3 OASIZ-301 results show both dosing regimens of Amgen’s CD40L antagonist fusion protein dazodalibep reduced systemic disease activity in Sjögren’s disease at Week 48. The every-four-weeks dose also improved patient-reported dryness.
FDA grants RMAT and Fast Track designations to AbelZeta’s CD20/CD19 bispecific CAR-T prizlon-cel in relapsed or refractory large B-cell lymphoma, Larimar Therapeutics completes a BLA seeking accelerated approval of nomlabofusp for Friedreich’s ataxia, and Merck’s GLP-1/glucagon receptor agonist efinopegdutide meets its primary endpoint in a phase 2b MASH trial.
Larimar Therapeutics has completed its rolling BLA for nomlabofusp, a frataxin replacement fusion protein, seeking accelerated approval based on skin frataxin as a novel surrogate endpoint. The company expects a potential US approval in mid-2027.
FDA granted RMAT and Fast Track designations to AbelZeta’s anti-CD20/CD19 CAR-T therapy prizlon-cel for relapsed or refractory large B-cell lymphoma. The company plans US studies after prior CAR-T therapy and in the second-line setting.
argenx agrees to acquire macrocyclic peptide developer Unnatural Products for up to about $1.15 billion, Johnson & Johnson’s pasritamig and JNJ-9401 bispecific regimen achieves a 73% PSA response in phase 1 in metastatic castration-resistant prostate cancer, and Janux Therapeutics’ TRBV6-targeted T-cell engager JANX011 shows deep B-cell depletion in healthy volunteers.
More monoclonal antibodies are moving from IV infusion to subcutaneous injection, but dose, volume, and viscosity still limit the switch. This FAQ covers the formulation science, the enabling technologies, what regulators require, and what remains unresolved.
A single subcutaneous dose of Janux’s CD19-targeted T-cell engager JANX011 depleted more than 90% of B cells in three of five healthy volunteers at the top dose, with only Grade 1 cytokine release syndrome. Patient studies in immune thrombocytopenia and rheumatoid arthritis are planned for 2027.
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