Manufacturing

The FDA has granted accelerated approval to Trutakna, a recombinant fusion protein that simultaneously inhibits BAFF and APRIL, for adults with primary IgA nephropathy at risk for disease progression — marking the first approval of a dual BAFF/APRIL inhibitor in the US and a significant advance in the growing wave of targeted biologics for this immune-mediated kidney disease.

LTZ Therapeutics has received FDA IND clearance for LTZ-232, a first-in-class bispecific antibody designed to activate tumor-associated macrophages to phagocytose EpCAM-positive colorectal cancer cells — a novel myeloid-engaging approach aimed at overcoming the immunologically cold tumor microenvironment that has historically limited immunotherapy in this setting.

Biocytogen and Whitehawk Therapeutics have announced a global collaboration combining Biocytogen's RenLite bispecific antibody discovery platform with Whitehawk's CPT113-based ADC linker-payload technology to generate bispecific ADC candidates with differentiated tumor-targeting profiles — with Whitehawk targeting new ADC INDs within 12 to 24 months.

A phase 2 controlled human infection trial has found that two doses of WRSs2, a live-attenuated oral vaccine candidate against Shigella sonnei, achieved 89% protection — the highest efficacy reported for any Shigella vaccine candidate — with no serious adverse events, advancing a century-long quest for a licensed vaccine against the diarrheal pathogen.

The European Investment Bank-backed investment establishes a new single-use GMP facility with which Icosagen can support complex protein therapeutics from early discovery through phase 1/2 clinical manufacturing.

During an interview with BioPharm International, Cencora experts Andrea Zobel, senior manager of dangerous goods, and Marco Hogenboom, senior director of specialty logistics, highlighted the unique regulatory, logistical, and educational challenges associated with delivering radiopharmaceutical therapies to patients worldwide.

The supplemental approval is based on immunogenicity data from the STRIDE-13 phase 3 trial and, according to Merck, makes the vaccine the only one of its type specifically indicated for this at-risk pediatric population in the United States.

The company reported that phase I data show approximately 40% of patients remained cancer-free at 10 years, while 2 phase 2 trials are ongoing.

Cytiva’s Pierre-Alain Ruffieux discusses standardization, regionalization, talent gaps, and regulatory pathways shaping advanced biomanufacturing’s future ahead of BIO 2026.

The company reported that all three participants in the 3 µg/kg dose cohort achieved a ≥25% SALT score reduction following single-dose subcutaneous administration, with dose escalation ongoing toward a recommended phase 2 dose.

Johnson & Johnson reported that the MonumenTAL-3 trial showed 24-month progression-free survival up to 81.3% and overall survival up to 89.2% with the GPRC5D bispecific combination versus standard of care.

Gan & Lee has reported positive topline trial results for insulin ludefen in type 2 diabetes and the GLP-1 bofanglutide in obesity.

Andrea Zobel and Marco Hogenboom of Cencora World Courier discuss how advances in radiopharmaceutical manufacturing, cancer biology, and specialty logistics are enabling the expansion of targeted radiopharmaceutical therapies into larger patient populations and broader oncology indications.

Phase 3 cancer vaccines and rare disease programs are positioning mRNA therapeutics beyond COVID-19, expanding precision treatment opportunities across oncology and genetic disorders.

According to Eli Lilly and Company, the extended dosing interval reduces maintenance injections to as few as 6 per year without required topical corticosteroids.

Phase 3 data from Boehringer Ingelheim’s SYNCHRONIZE-1 and SYNCHRONIZE-MASLD trials meet their primary endpoints, with glucagon/GLP-1 dual agonism showing targeted metabolic fat reduction beyond body weight loss at 76 and 48 weeks.

Made Scientific and Pluristyx will integrate iPSC starting materials with CDMO services for cell therapy development.

As the ADC market races toward a projected $32 billion valuation, manufacturers face a precision imperative, as integrated CDMO partnerships, advanced analytics, and emerging technologies like AI and continuous manufacturing may hold the key to unlocking the next wave of oncology breakthroughs.

Dual primary endpoints were met in both PANKU-Breast02 and PANKU-Esophagus01 phase 3 trials based on interim analyses, while priority review is underway for the esophageal cancer indication in China, Bristol Myers Squibb and Biokin stated.

Webinar Date/Time: Tue, Jun 23, 2026 11:00 AM EDT

Biopharma in 2026 advances decentralized manufacturing, AAV automation, QC modernization, and APAC clinical trial strategy.

BioNTech and Bristol Myers Squibb report confirmed ORRs exceeding 60% at the lower dose in both non-squamous and squamous first-line NSCLC; three global Phase 3 trials are now enrolling.

Webinar Date/Time: Wed, Jun 24, 2026 11:00 AM EDT

Point-of-care manufacturing could expand personalized medicine by enabling faster, decentralized drug production, though quality and regulatory hurdles remain.

Fosun Pharma has dosed the first participant in a mainland China trial of FXB0871, as a parallel phase 1 study continues in the United States and Canada under Teva's TEV-56278 designation