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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.

Novartis will invest $23 billion during the next five years to expand manufacturing and R&D in the US, which will include seven new facilities and a new research hub.

The spray-dried formulations for Ethris’ mRNA vaccine candidates will be developed at Lonza’s Bend, Ore., Center of Excellence in accordance with GMP standards.

At INTERPHEX 2025, the Pharmaceutical Technology® Group spoke with Joe Katakowski, director of Research at the RTW Foundation on how challenging it is to develop treatments for ultra-rare diseases.

Even with, or perhaps because of, the rapidity with which changes in United States policy are developing, many in the bio/pharmaceutical industry are taking a longer view.

Andrew Moreo, head of Process Development and Pre-clinical Manufacturing at Andelyn Biosciences, talks with BioPharm International® about the benefits and challenges of gene therapies developed to treat cancer.

Through this collaboration, Circio will combine its circVec DNA vectors with Entos’ Fusogenix PLV delivery technology, which is expected to enhance delivery efficiency and reduce toxicity.

The acquisition of Rweality will strengthen Enosium Life Science’s market access and medical-economic development strategies.

The EMA has issued a new proposal that aims to encourage biosimilar development and improve patient access to biosimilar therapies.

As single use becomes more prevalent, end users are looking for more customization, and regulators are refining their rules, says Todd Andrews of CPC in an interview with Pharmaceutical Technology® Group.

Rising demand for peptide-based therapeutics prompts the launch of this new peptide research center, which will offer services across peptide synthesis, discovery, and advanced modalities.

This paper outlines a systematic approach to detecting contamination through process deviations, including changes in % dissolved oxygen, pH, and metabolic patterns.

Wider adoption of single-use technologies and systems is aligning with sustainability goals for the industry.

Process consistency and robustness, analytical excellence, and regulatory compliance are essential in the scale-up of biosimilars.

Sitting down with the PharmTech Group at INTERPHEX 2025, Michael Franco, global sales director at PSG Biotech, discussed the recent advancements in pharmaceutical flow sensor technology.

The shift toward personalized medicines poses new challenges in cleanroom protocols.

Nicole Hunter, head of Global WMArchitect at WMFTS, sat with the PharmTech Group at INTERPHEX 2025 to discuss the industry initiative around single-use assembly components that was prompted by the supply disruptions caused by the COVID-19 pandemic.

At INTERPHEX 2025, the PharmTech Group spoke with Dave Loula, global product director, ITT Engineered Valves, about innovation in advanced sensing technologies that answer customers' need for reliable valve function.

More and more contract manufacturers have been looking not at what the state of the supply chain is right now, but what it may be in the next three to five years.

Christopher Murphy, director of Global Business Development and Service Customer Support at Environmental Specialties, sat down with the PharmTech Group at INTERPHEX 2025 to discuss the design and critical role of walk-in chambers in the bio/pharmaceutical industry.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.

Speaking at INTERPHEX 2025, William Wainwright, business development manager at Iwata Label USA, discusses the practical benefits of functional labels in protecting parenteral drugs.

Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.

BioPure’s BioClamp connector has been upgraded and is now manufactured to be 13% lighter than the previous model, allowing users to achieve a 26% reduction in carbon dioxide emissions across the full lifecycle of a product.