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CHMP meeting highlights – May 2025
The EMA’s committee has granted positive opinions for ten new treatments, including medicines for oncology indications and rare diseases.
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Biologics
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Pharma Horizons: the future of cell and gene therapy
This exclusive report addresses the key challenges and breakthroughs shaping the future of cell and gene therapy, from QC and analytical development to advanced manufacturing strategies. Discover practical solutions you can implement to drive progress for your organisation.
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Innovative CAR T therapy could deliver in broader therapeutic settings, research suggests
The novel cell therapy utilises a shortened manufacturing process compared to standard production timelines, offering potential for enhanced therapeutic capability.
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New J&J data signals progress in ulcerative colitis treatment landscape
The biologic delivered sustained remission in adults with the inflammatory bowel disease (IBD) over the two-year study, results show.
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CHMP meeting highlights – April 2025
The Committee for Medicinal Products for Human Use (CHMP) recommended approval of a variety of new medicines, including several treatments for hereditary and rare conditions.
webinar
Achieving rapid microbial method validation with precise reference standard quantification
25 April 2025 | By Rapid Micro Biosystems and ATCC
This webinar explores validation of rapid microbial methods with ready-to-use reference materials, a new industry standard in microbial QC testing.
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Antibody treatment demonstrates potential in lupus kidney disease
The findings suggest that the biologic treatment could improve short-term outcomes for patients with lupus nephritis.
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FDA approves novel therapy for chronic skin condition
The US approval could improve outcomes for eligible patients with previously limited options for managing the inflammatory skin condition.
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New analysis sets stage for improved UK clinical trials
Observations from the report will help the MHRA to strengthen clinical research and lay the foundation for accelerated innovation and medicine delivery to patients in the UK.
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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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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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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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European Pharmaceutical Review Issue 1 2025
EPR Issue 1 includes articles on manufacturing, drug delivery, process analytical technology (PAT), RNA therapeutics and more.
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Alzheimer’s drug requires strengthened pharmacovigilance approach
Ongoing real-world safety and effectiveness monitoring of the Alzheimer’s drug lecanemab is needed to protect patients long-term, drug safety researchers urge.
webinar
Advancing endotoxin testing: implementing sustainable recombinant LAL solutions
7 March 2025 | By Fujifilm Wako
Discover the benefits of sustainable recombinant LAL for endotoxin testing. Learn about its relevance, selection considerations, and seamless integration into your lab processes with expert insights.
