Biopharma News

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.

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.

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.

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.

Iksuda Therapeutics has received FDA clearance of its IND application for IKS04, a CA242-directed antibody-drug conjugate paired with a novel dosing approach designed to improve solid tumor penetration, enabling a Phase 1 trial in gastrointestinal cancers.

Johnson & Johnson has entered a collaboration and equity investment agreement with Sail Biomedicines to advance in vivo CAR-T therapies for immune-mediated diseases, securing an exclusive option to acquire the company for $2.58 billion.

Today's episode explores how FDA expedited pathways continue to shape advanced therapy development, from new RMAT designations for cell and gene therapies to an advisory committee review that underscores the agency's evolving expectations for clinical evidence.

The FDA has granted Regenerative Medicine Advanced Therapy designation to Ocugen's OCU410, a one-time AAV gene therapy for geographic atrophy secondary to dry age-related macular degeneration, based on Phase 2 data showing a statistically significant reduction in lesion growth.

Paul Romness, chair, chief executive officer, and president of OS Therapies, discusses how advances in linker chemistry, payload design, and evolving regulatory approaches could shape the next generation of antibody–drug conjugates for oncology.

In this episode, Ron Lanton argues that healthcare's next constraint isn't capital or technology but rather people.

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.

Today's podcast episode highlights three stories shaping the future of antibody therapeutics, from a next-generation bispecific ADC advancing toward the clinic, to a new biologics innovation consortium in China, to a major acquisition expanding an autoimmune pipeline.

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.

As biopharmaceutical manufacturing becomes increasingly automated, real-time analytical data is poised to transform how manufacturers monitor processes, make decisions, and optimize production. Bryan Hassell, founder and CEO of Nirrin Technologies, discusses why trusted, continuous measurements will be essential to the next generation of digital biomanufacturing.

Arrowhead's plozasiran cut triglycerides up to 81% and pancreatitis events up to 100% in phase 3 trials, Greenwich LifeSciences expanded its GP2 breast cancer vaccine trial into the UK, and Ipsen completed its acquisition of Memo Therapeutics to add the first-in-class antibody potravitug to its rare disease pipeline.

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.

Arrowhead's plozasiran cut triglycerides up to 81% and pancreatitis events up to 100% in phase 3 trials, Greenwich LifeSciences expanded its GP2 breast cancer vaccine trial into the UK, and Ipsen completed its acquisition of Memo Therapeutics to add the first-in-class antibody potravitug to its rare disease pipeline.

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.

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.

Prevention, precision, and progress take center stage as researchers report advances in pancreatic cancer prevention, uncover new insights into colorectal cancer immunotherapy, and introduce the first rapid-onset botulinum toxin approved in Europe.

A preclinical study links a DR5-Lig3 feedback loop to immune recognition and checkpoint inhibitor response in dMMR colorectal cancer.

A phase 1 trial of mKRAS-VAX, an off-the-shelf synthetic peptide vaccine targeting mutant KRAS, safely stimulated durable, tumor-specific T-cell responses in 90% of high-risk individuals, with none of the 20 participants developing pancreatic cancer after a median follow-up of 16.5 months.

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

Nirrin Technologies founder and CEO Bryan Hassell discusses how simplifying protein quantitation could improve method transferability, support automation, and reduce bottlenecks across biologics development and manufacturing.

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.