News

The complications of conjugate molecules, such as oligonucleotides, are explored in this second portion of an interview with Abzena experts.

Our top 10 videos of the year cover AI, innovation, compliance, and sustainability in biopharma.

FounderNest CEO Feliz Gonzalez breaks down where the biotech market stands today and where it’s headed in 2026

The top 10 BioPharm International articles of 2025 highlight policy shifts, manufacturing innovation, and strategic partnerships.

In the first part of an extended video interview, Petra Dieterich and Jeffrey Mocny of Abzena emphasize that every part of the process of developing novel biologics is designed to bring them to humans not just quickly, but also safely.

A look at interchangeable biosimilars gaining FDA approval, the growth in global partnerships, and the rising biologics patent cliff.

Samsung Biologics’ Maryland acquisition signals a major push into US biologics manufacturing, reshaping the company’s capacity strategy and supply chain resilience.

$17.5M biopharma alliance leverages CAMP4's tech, addressin protein under-expression in haploinsufficient disorders

EMA Director sees new legislation as an opportunity to revamp policies.

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates (RCA), and Siegfried Schmitt, Parexel, tackle the ever-growing problem of having a properly trained workforce with a variety of needed skill sets.

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.

In Episode 30, John Androsavich, Benjamin Fryer, and John Wilkerson go behind the headlines.

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

Surface modification with targeting ligands increases the advantages offered by nanoscale delivery.

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

FDA leadership initiated rapid drug review programs, enhanced transparency by publishing decision letters in real time, and strategically integrated AI into agency operations.

Chris Spivey explains how billions wasted on flawed near-infrared glucose sensing could have been avoided.

Targeted integration enables predictable clonal cell lines, enhancing transgene control and accelerating biopharma cell line development.

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

The third installment of the monthly BioPharma By the Numbers infographic series details batch failure trends in biopharma.

In Episode 29, John Androsavich, Benjamin Fryer and John Wilkerson go behind the top headlines from 2025.

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.

The articles in this issue capture a sector balancing innovation with practicality as it prepares for the next generation of medicines.

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

Manufacturing biologics is a complex task. Mitigating risk early in the design of manufacturing facilities and the qualification of equipment minimizes future complications.