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Umoja Biopharma has received FDA clearance of its IND application for UB-VV400, a CD22-directed in vivo CAR T-cell therapy candidate built on the company's VivoVec lentiviral platform, positioning it as the industry's first known in vivo CAR T program targeting CD22 for relapsed or refractory B-cell malignancies.

At BIO 2026, Thermo Fisher Scientific's Paul Jorjorian highlighted late-stage raw material switches as being among the most disruptive and underestimated risks in biopharma development.

Boehringer Ingelheim has started a phase 2 trial of BI 3034701, an investigational triple GLP-1/GIP/NPY2 receptor agonist for obesity and overweight.

Deck Bio’s Dr Johanna K. Kaufmann spoke at BIO 2026 about how the company’s multi-peptide major histocompatibility complex T cell engager strategy aims to expand patient eligibility and overcome solid tumor heterogeneity and antigen escape resistance.

Oncolytics Biotech CEO Jared Kelly warns that investor demand for near-term tumor response data is blocking funding for trials with proven overall survival benefits.

Updated clinical findings for brenetafusp highlight how T-cell receptor bispecific therapies may overcome key mechanisms of checkpoint inhibitor resistance while expanding immunotherapy to a broader range of solid tumors.

FDA has granted priority review to obinutuzumab (Gazyva) for primary membranous nephropathy after phase 3 MAJESTY trial results showed superior remission versus tacrolimus.

Allogene Therapeutics has published complete phase 1 data in the Journal of Clinical Oncology for ALLO-316, a CD70-targeted allogeneic CAR T therapy, showing a 31% confirmed response rate and durable remissions in patients with high CD70-expressing metastatic renal cell carcinoma.

As part of our continuing coverage from the BIO International Convention 2026, Pharmaceutical Executive spoke with Martha Fowler, founder of Steer Bio, about the company's regenerative medicine platform, its lead program for cancer-related lymphedema, and how non-dilutive funding is supporting its path toward first-in-human studies.

Voyager Therapeutics presented six-month GLP toxicology data showing its tau-silencing AAV gene therapy VY1706 was well tolerated and reduced tau protein by up to 75% in key brain regions of non-human primates, with a clinical trial in Alzheimer's disease expected to begin in the second half of 2026.

The FDA has approved lecanemab-irmb (Leqembi Iqlik) a once-weekly subcutaneous autoinjector formulation, as an initiation dose for early Alzheimer's disease, making it the first anti-amyloid antibody offering at-home dosing across the entire treatment course, from initiation through maintenance.

Innovent Biologics and Spero Therapeutics have signed a $1.1 billion licensing deal for IBI355, a phase 2-ready Fc-silent anti-CD40L antibody planned for testing in IgG4-related disease and Sjögren's disease.

Today's BioPharm Brief highlights three regulatory and clinical milestones, including an FDA RMAT designation for a regenerative therapy in osteoarthritis, promising rectal cancer data from GSK's AZUR-1 study, and a new perioperative treatment option for muscle-invasive bladder cancer.