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China's NMPA has approved an IND for a Phase Ib/II trial combining Leads Biolabs' PD-L1/4-1BB bispecific antibody opamtistomig with standard regimens in metastatic colorectal cancer, extending the drug's reach into one of oncology's most immunotherapy-resistant tumor types.

Precision analytics and flexible manufacturing are helping to advance safer, scalable bispecific antibodies, antibody-drug conjugates, and central nervous system monoclonal antibodies from development to patients.

Three major regulatory milestones highlight this week's biopharmaceutical news, from a biosimilar advancing through FDA and EMA review to a new first-line breast cancer approval in Europe and fresh Phase 3 cardiovascular data that could reshape inflammatory disease drug development.

Planning the analytical strategy for product release should be started as early as possible to ensure product quality and regulatory success.

Novo Nordisk's ziltivekimab failed to reduce cardiovascular events in the phase 3 ZEUS trial despite confirmed IL-6 target engagement.

The EC has approved AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan ADC for 1st-line metastatic TNBC, which showed a 5.0-month overall survival benefit over chemotherapy.

Polpharma Biologics and Fresenius Kabi announced that the FDA and EMA have accepted for review PB016, a proposed biosimilar to Takeda's Entyvio (vedolizumab), with Fresenius Kabi holding exclusive global commercialization rights outside the Middle East and North Africa.

We answer readers’ top questions on limit of blank, limit of detection, limit of quantitation, acceptance criteria, and equivalence testing in analytical method validation.

This episode of The BioPharm Brief explores how next-generation biologics are reshaping oncology and autoimmune disease, from a first-line antibody-drug conjugate filing and a novel ADC entering the clinic to a major investment in in vivo CAR-T technology.

CMC teams can align with Q5A(R2)’s updated guidance to shorten testing timelines and strengthen assurance of participant safety.

An FDA warning letter to Purolea Cosmetics Lab shows that AI-assisted drafting can support documentation work only when the resulting document is subject to quality-system controls.

Kelun-Biotech's sac-TMT has gained NMPA acceptance for a new first-line indication application in advanced triple-negative breast cancer.

Collaboration between suppliers and developers, as well as viral vector manufacturing simplification, are becoming critical to CGT's commercial future, says Brandon Pence of FUJIFILM Biosciences.