News

As the J.P. Morgan Healthcare Conference gets underway, Lonza’s Michael De Marco weighs in on regional manufacturing shifts as biotech pipelines mature, signaling new therapy launches within 12–18 months.

Johnson & Johnson reinforces its long-term domestic investment strategy with a new $2 billion biologics facility in Wilson, North Carolina, further elevating the state’s role as a global life sciences hub.

In part two of an interview, Daniel Delubac, iOrganBio CEO, explains how digitized, in-vitro human biology models aim to improve preclinical drug testing.

AI-driven human cell models aim to replace animal testing and deliver more accurate, data-driven insights, says iOrganBio CEO Daniel Delubac ahead of the J.P. Morgan Healthcare Conference.

EU approval of a prefilled Shingrix syringe streamlines vaccine delivery, while Phase III data position bepirovirsen as a potential functional cure for hepatitis B.

In a new team-up, MD Anderson and SOPHiA GENETICS will apply advanced analytics to cancer testing to improve complex data interpretation for clinical use.

Single-use technologies provide efficiency and flexibility while reducing risk in the manufacture of cell and gene therapies.

Digitalization is expected to reshape bioprocessing, supply chains, and quality systems for biopharma developers amid tariffs, geopolitics, and shifting capital flows, according to BioPlan Associates’ Eric Langer.

The CDC has narrowed pediatric vaccine guidance, resetting evidence expectations and signaling potential shifts in vaccine uptake and market demand.

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.

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.

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.