News

China’s authorization of GSK’s Nucala (mepolizumab) for treating COPD signals regulatory momentum for precision respiratory medicines in the country.

The company hopes the rebranding effort will better align with its work in cell culture media manufacturing.

The company’s Phase III setrusumab trials in osteogenesis imperfecta missed fracture endpoints but showed strong bone density gains.

In the final part of an interview with Petra Dieterich and Jeffrey Mocny of Abzena, the current tariff situation in the United States and beyond is considered.

Biomanufacturing is shifting toward more resilient and digitized networks for enhanced supply security amid global and supply-chain volatility.

In the biopharma industry during 2025, quality, tariffs, MFN pricing, and strategic outsourcing deals drove innovation and investment.

Key 2025 FDA draft and final guidances emphasize the modernization of biotech regulations, acceleration of rare-disease therapies, and streamlining of biosimilar pathways.

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.

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

Autolomous and Trenchant’s partnership, begun early in 2025, addresses unmet CGT manufacturing needs, including slashing costs and cutting timelines.

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.

Advances in precision analytics have pushed the needle forward in characterizing and assessing the safety and quality of next-gen biologics.

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.