Manufacturing

Ahead of a July 29 FDA advisory committee meeting, the FDA released briefing documents disputing Capricor Therapeutics' claim that its Phase 3 HOPE-3 trial of deramiocel, a cell therapy for Duchenne muscular dystrophy cardiomyopathy, met its primary and secondary efficacy endpoints, a disagreement centered on which version of the trial's statistical analysis plan should govern the results.

AbelZeta has received FDA RMAT clearance for a registrational phase 2 trial of its bispecific CAR-T therapy, C-CAR168, in refractory lupus nephritis.

GSK will invest £400 million (US$532 million) in a new Cambridge, UK, R&D center, relocating from Stevenage amid second quarter earnings and a cost-savings plan.

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Veraxa Biotech has advanced its bispecific antibody-drug conjugate program VXA-222 into its next development phase after OmniAb completed discovery work under their May 2025 collaboration, creating a dual-antigen "AND-gate" candidate designed to improve precision in solid tumor treatment.

A Phase 1 trial of DYP688, a first-in-class antibody-drug conjugate targeting the Gq/11 pathway, showed disease control in more than 80% of patients with metastatic uveal melanoma and was well tolerated, according to findings published in Nature Medicine, even after Novartis halted the drug's development.

A new peer-reviewed publication in Clinical Cancer Research details preclinical data for Pheast Therapeutics' PHST001, an anti-CD24 monoclonal antibody, showing anti-tumor activity across six solid tumor types and enhanced effects when combined with chemotherapy, radiotherapy, and antibody-drug conjugates.

The European Medicines Agency has granted orphan designation to Atsena Therapeutics' ATSN-101 and ATSN-201, AAV gene therapies for Leber congenital amaurosis 1 and X-linked retinoschisis, as both programs advance toward pivotal Phase 3 trials.

Greenwich LifeSciences has received UK regulatory approval to expand its Phase III FLAMINGO-01 trial of GLSI-100, a HER2-derived peptide cancer vaccine designed to prevent breast cancer recurrence, adding up to 10 new UK sites through a collaboration with The Royal Marsden.

Propanc Biopharma has reported peer-reviewed data on scalable recombinant production of trypsinogen and chymotrypsinogen, supporting a synthetic backup to its lead cancer candidate, PRP.

Imunon has reported positive preliminary data from its phase 2 minimal residual disease study of IMNN-001, a DNA-based IL-12 gene immunotherapy, showing a lower MRD-positive rate, higher ctDNA clearance, and more patients reaching no evidence of disease compared to standard chemotherapy alone in frontline advanced ovarian cancer.

MilliporeSigma's Sebastián Arana outlines why flexible, platform-based manufacturing and workforce training are now table stakes for competitive biomanufacturers.

Scholar Rock’s apitegromab is awaiting a US manufacturing facility resolution, which may impact the therapy’s European review, for which clinical assessment has been completed.

Keytruda improved progression-free survival versus chemotherapy in first-line dMMR advanced or recurrent endometrial cancer.

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.

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.

ImmunoBrain has published phase 1b data in Nature Medicine and presented late-breaking results at AAIC 2026 for IBC-Ab002, an investigational anti-PD-L1 monoclonal antibody that met its primary safety endpoint and showed encouraging trends in biomarkers of neuronal and synaptic damage in patients with early Alzheimer's disease.

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.

The FDA has approved Padcev, a Nectin-4-directed antibody-drug conjugate, plus Keytruda as neoadjuvant and adjuvant treatment for muscle-invasive bladder cancer regardless of cisplatin eligibility, based on Phase III EV-304 data showing a 47% reduction in recurrence risk.

The FDA has granted Regenerative Medicine Advanced Therapy designation to Allocetra, Enlivex's macrophage-reprogramming cell therapy, for age-related symptomatic knee osteoarthritis in patients 64 and older, based on Phase I/IIa data showing durable pain and function improvements.

GSK reports that dostarlimab (Jemperli) monotherapy achieved sustained clinical complete responses in the phase 2 AZUR-1 trial for dMMR/MSI-H locally advanced rectal cancer, with data to be submitted for regulatory review.

Opamtistomig, a PD-L1/4-1BB bispecific antibody from Nanjing Leads Biolabs, has been granted priority review by China's NMPA for advanced extrapulmonary neuroendocrine carcinoma, a rare and aggressive cancer with no globally approved therapy.

The FDA has approved subcutaneous Sarclisa Escena, administered via on-body injector, across all existing multiple myeloma indications for the IV formulation, making isatuximab the first anticancer monoclonal antibody available through both wearable injector and manual subcutaneous administration in the US.