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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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FDA approves first-of-a-kind gene therapy for dystrophic epidermolysis bullosa
With clinical data showing the gene therapy can address large and challenging chronic wounds, the FDA’s decision will help improve quality of life for dystrophic epidermolysis bullosa (DEB) patients.
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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.
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AI-driven biomanufacturing: revolutionising production and quality in pharmaceuticals
This article explores how artificial intelligence (AI) is forming an essential pillar of staying competitive in pharmaceutical manufacturing, with its adoption ensuring greater efficiency of medicine production in this fast-evolving sector.
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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Boehringer agrees new partnership to advance first-in-class precision cancer therapies
The collaboration between Boehringer Ingelheim and Tessellate Bio seeks to address availability of targeted medicines for a cancer type shown to be difficult to treat.
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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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QbD for biopharmaceutical product lifecycle management
Youngsun Kim and Busol Park from Samsung Biologics detail the benefits of using a Quality-by-design approach for biologics manufacturing.
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Eli Lilly releases topline data for new oral GLP-1
Subject to regulatory approval, the small molecule drug could provide a new treatment option for diabetes and obesity, Eli Lilly’s new data suggests.
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European Commission Alzheimer’s drug approval marks advancement for EU patients
Lecanemab is the only approved Aβ monoclonal antibody that highly binds to and clears toxic protofibrils with high selectivity.
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Innovative approach could improve cancer immunotherapy
A clinical trial is currently investigating the potential of CD40L-enhanced tumour-infiltrating lymphocyte (TIL) cancer therapy in non-small cell lung cancer.
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NICE recommends new combination breast cancer drug
The agency’s recommendation could provide eligible breast cancer patients with a treatment that analysis suggest is to likely to work as well as two medicines already recommended by NICE.
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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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CPI launches first-of-a-kind digitalisation framework
CPI’s strategy will help pharmaceutical industry partners to accelerate digitalisation of the pharmaceutical manufacturing process.
