BioBusiness

This past year in biologics was marked by clinical trends, manufacturing scalability, and regulatory acceleration for antibody therapeutics.

Norgine has gained regional rights to Vir Biotechnology’s hepatitis delta drug pairing, strengthening late-stage antiviral development across Europe, Australia, and New Zealand.

European regulators authorize AstraZeneca’s anifrolumab pen for lupus, reinforcing industry momentum toward self-injected biologics and decentralized immunology care.

Fondazione and Orphan Therapeutics outline a US access model for Waskyra, highlighting new approaches to manufacturing, distribution, and sustainability.

Charles River has launched a second cohort to speed CGT innovation with technical guidance and scalable manufacturing support.

The new GSK–Oxford BioTherapeutics partnership capitalizes on proteomics-driven oncology target discovery for advancing antibody therapeutics development.

FDA’s approval of the first Wiskott-Aldrich gene therapy signals a shift in manufacturing and regulatory standards for rare-disease CGTs.

FDA’s clearance of a chemically enhanced stem cell therapy for severe aplastic anemia drives forward cell therapy development and manufacturing innovation.

Priority review, RMAT, and breakthrough status were key regulatory actions intensely accelerating advanced next-gen therapy development in 2025.

Under the expanded agreement, the companies are targeting amyloid removal strategies to address unmet needs in rare diseases.

siRNA-based cell reprogramming shows potential to improve metabolic health with durable effects, signaling a notable development for future therapeutic strategies.

The discussion in this Drug Digest video focuses on optimizing biopharmaceutical manufacturing and supply chain efficiency through the mastering of AI capabilities, data integration, and critical validation challenges.

Samsung Life Science Fund’s investment in Phrontline Biopharma highlights growing industry momentum behind dual-payload ADCs.

AstraZeneca’s $2 billion investment in its Maryland facilities will expand domestic biologics and rare disease manufacturing and strengthen US drug supply chains.

RxCelerate and Constructive Bio will combine programmable biology with integrated discovery tools to speed engineered biologics for hard-to-treat diseases.

The company demonstrates advances in glioma hydrogel, high-concentration biologics, and nanoencorafenib licensing, impacting drug delivery strategies.

At AAPS PharmSci 360, Kelly Donovan says tailored analytical strategies are necessary for reducing development delay risks.

Financing strategies for new modalities and AI will be central at PharmSci 360, shaping how advanced therapeutics move toward global patient access.

A new Cue Biopharma–ImmunoScape partnership seeks to advance targeted TCR-T expansion for solid tumors, supporting broader access and improved clinical durability.

Biopharma innovators were recognized at CPHI 2025 for advances in drug delivery, continuous bioprocessing, and supply chain capabilities shaping global therapies.

Novartis’ acquisition accelerates RNA drug innovation, expanding genetic therapy pipelines and reshaping biomanufacturing strategies for neuromuscular disease.

Abzena’s antibody platform enables Orion to streamline biologics development, showcasing trends in scalable, risk-reduced manufacturing for the industry.

SK pharmteco expands US peptide production capacity, strengthening domestic API manufacturing and accelerating biopharma process development.

Non-parenteral alternatives for biologics remain a clinical imperative and a formidable challenge.