Editorial Podcasts

In this episode of The BioPharm Brief, we cover the FDA approval of Lupin's interchangeable ranibizumab biosimilar Ranluspec, a new iPSC cell therapy manufacturing partnership between Made Scientific and Pluristyx, and emerging research on TIGIT as a potential immunotherapy target in pancreatic cancer.

Today’s BioPharm Brief covers major developments in oncology, rare disease therapeutics, and ADC manufacturing, including positive Phase 3 data for Kelun-Biotech’s sac-TMT in triple-negative breast cancer, promising hypochondroplasia results for vosoritide, and new perspectives on risk-based cleaning validation for highly potent drug manufacturing.

This edition of The BioPharm Brief highlights major advances in obesity, oncology, and regenerative medicine, including Merck’s Phase 3 ADC study in metastatic colorectal cancer, Eli Lilly’s promising retatrutide obesity trial results, and manufacturing progress supporting Klotho cell therapy development. Together, these updates reflect the biopharma industry’s accelerating focus on targeted therapies, next-generation weight loss drugs, and scalable cell therapy innovation.

FDA approvals, biotech acquisitions, and clinical trial updates are shaping today’s biopharma landscape. This episode of The BioPharm Brief covers the first approved PROTAC therapy for breast cancer, UCB’s planned acquisition of Candid Therapeutics, and new clinical data from Takeda Pharmaceutical Company in primary immunodeficiency.

The BioPharm Brief covers three recent FDA developments shaping the autoimmune and inflammatory disease landscape. The agency cleared a subcutaneous autoinjector for anifrolumab in systemic lupus erythematosus, enabling at-home administration. It also granted Priority Review to nipocalimab for warm autoimmune hemolytic anemia, highlighting its potential as a targeted treatment for a rare condition. In addition, a supplemental application has been submitted for subcutaneous risankizumab as an induction therapy in Crohn disease, which could reduce the need for infusion-based initiation. Together, these updates reflect a growing focus on patient convenience, expanded access, and more precise treatment approaches in immune-mediated diseases.