The first patient has been dosed in a Phase II clinical trial for the company’s MB-105 first-in-class CD5-targeted CAR-T cell therapy.

The investment will be done over five years and will include new, state-of-the-art R&D facilities as well as new or expanded manufacturing sites in multiple US states.

Innovative continuous manufacturing technology and advanced facilities are revolutionizing biomanufacturing and driving cost efficiency, especially in monoclonal antibody production.

Paige’s state-of-the-art foundation models will be integrated with Sonrai’s intuitive cloud-based data analysis and bioinformatics platform.

Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.

Using cholesterol-modified oligonucleotides, the research team aims to improve the delivery of antisense nucleotide-based therapies for treating neurodegenerative diseases and brain cancers.

The 6000-square-foot facility will provide cell therapy developers the support they need to transition to CGMP manufacturing, and an expanded footprint of the new center is expected to open in Philadelphia later in 2025.

The recombinant vaccine, under the brand name Vimkunya, is recommended for persons age 12 and older who are traveling to a country or territory where there is a chikungunya outbreak.

This collaboration aims to advance a first-in-human clinical study by using autologous iPSC technology.

Celltrion’s adalimumab-aaty is designated interchangeable as a high-concentration (100mg/mL) and citrate-free formulation of adalimumab.

Eculizumab-aagh (EPYSQLI) is now available in the US to treat patients living with difficult-to-treat rare diseases such as paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and generalized myasthenia gravis.

Pharmaceutical Technology® Group spoke with Erik Wiklund, CEO of Circio, about the impact of the post-COVID-19 world on the pharmaceutical industry and how that has shifted the talent pool.

Artificial intelligence will be a major component, FDA said, of the approaches the agency will be deploying to either reduce, refine, or potentially replace animal testing.

The agency has approved BMS’ Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for unresectable or metastatic hepatocellular carcinoma.

BioPharm International® interviewed Edwin Stone, CEO of Cellular Origins, about the bio/pharmaceutical trends from 2024 that continue to impact the industry in 2025.