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USP boosts support for AAV-based gene therapy manufacturers
Alongside publication of the proposed General Chapter < 1067 >, the new resources from USP aim to help advance AAV gene therapies.
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Biopharma
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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.
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Could investigational drug become first-in-class bronchiectasis therapy?
The small molecule treatment is currently being reviewed by the US Food and Drug Administration (FDA), under the Prescription Drug User Fee Act (PDUFA).
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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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New drug delivery method for cell therapies reported
Findings from the proof-of-concept study highlight the safety of the novel delivery system for patients who are ineligible for standard intravenous cell therapy.
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From pipettes to processors: how AI Is reshaping pharma’s future
The rise of AI, digital twins, and advanced computational modelling signals a paradigm shift in pharmaceutical R&D. These advances are poised to challenge long-standing methodologies, demanding a workforce capable of navigating an evolving technological landscape. Alistair Henry, UCB’s Chief Scientific Officer, examines how the sector needs to embrace the shift…
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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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New EU guidance seeks to address radiopharmaceutical supply chain vulnerabilities
The recommendations are issued amid increasing pressure on the complex supply chain for radiopharmaceuticals, medicines which are used to treat conditions such as cancer.
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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.
