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Novel design proposed for aseptic processing areas
The approach offers key benefits such as facilitating a reduction in the risk of microbial contamination and reduction in the required air change rate in aseptic processing.
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Therapeutics
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AI in pharmaceutical development: hype or panacea?
Dave Elder reflects on the array of applications for AI to facilitate successful drug development, though proof remains elusive.
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EMA proposes streamlined approach for biosimilar development
In certain cases, analytical comparability exercises and PK data could be sufficient for demonstrating biosimilarity, the EMA highlights in its new paper.
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Innovative framework could enhance process efficiency in manufacturing quality control
The proposed approach demonstrates benefit for real-world application, establishing more robust, adaptive, and economical process systems, the research suggests.
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Novo Nordisk gains rights to novel small molecule inhibitor
As part of the agreement with Novo Nordisk, Lexicon Pharmaceuticals is eligible for total of $1 billion in upfront and potential milestone payments, alongside royalties.
whitepaper
Accurate and Reproducible Quantitation of xC/UV/MS Data from Any Instrument
31 March 2025 | By
Learn how Medtronic processes and quantifies their xC/UV/MS data using the quantitation workflow in MS Workbook Suite.
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Pharma Horizons: Artificial Intelligence
EPR's latest Pharma Horizons report explores the latest advances in artificial intelligence (AI) for drug and clinical development, regulation and more.
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The case for immigration concessions: maintaining the UK’s competitiveness in science and technology
Immigration law experts from Fragomen LLP discuss currently challenges in the UK’s visa system and propose recommendations for attracting science and technology talent that support the country’s competitiveness.
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Tariffs could threaten medicine innovation, industry bodies warn
Biotechnology Innovation Organization (BIO) and the International Generic and Biosimilar medicines Association (IGBA) highlight the need for industry cooperation to support the potential impact of tarrifs.
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FDA approves first-in-class oral antibiotic
The drug is the first in a new class of oral antibiotics for uncomplicated urinary tract infections in nearly three decades.
webinar
Leveraging early insights to accelerate the oral drug development cycle
26 March 2025 | By Thermo Fisher Scientific Pharma Services
This webinar explores oral drug product development and how to address critical challenges such as complex formulations and regulatory hurdles.
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MSD to advance investigational Lp(a) inhibitor in nearly $2b deal
The new license agreement will support development of a potential additional treatment option for patients at risk of atherosclerosis.
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Optimal biosafety cabinet cleaning strategy proposed
The research highlights a potential approach to address cross-contamination challenges during cell-processing operations.
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Drug for rare form of Alzheimer’s “scientifically promising”
The anti-amyloid drug study highlights the importance of longer-term follow-up to determine benefits and risks of dementia treatments.
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European Pharmaceutical Review Issue 1 2025
EPR Issue 1 includes articles on manufacturing, drug delivery, process analytical technology (PAT), RNA therapeutics and more.
