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Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing
Colleagues from biopharmaceutical company MSD reveal what it takes to fully realise the benefits of PAT implementation.
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Therapeutics
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GSK to advance antibody medicines for neurodegenerative diseases
The licensing agreement will support development of medicines for delivery across the blood-brain barrier to treat neurological disorders like Alzheimer’s and Parkinson’s.
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Sampling system offers unique strategy for airborne bacterial detection
The proposed technique holds value for real-time monitoring and surveillance of airborne bacteria with high sensitivity and rapid results, the study showed.
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The key role of GMP analytical testing for drug products
Ensuring the quality, safety and efficacy of new pharmaceutical products is critical to bring them to market successfully. Here, Adragos Pharma’s Amalia Stroumpou, explains how the key to all three of these factors is rigorous good manufacturing practice (GMP) analytical testing.
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Prioritise cultural change to enhance pharma digital innovation efforts, says Pistoia Alliance
The research highlights that major barriers to digital innovation in life sciences include cultural attitudes on AI’s potential, governance and digital skills.
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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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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.
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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.
