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20 October 2025 | By
The balance between speed, scale, and compliance has never been more critical. As GLP-1s, biosimilars, and advanced therapies reshape global priorities, pharma leaders face a new question: how can manufacturing infrastructure evolve fast enough to keep pace?
Regulator classifies former Catalent site as ‘official action indicated’, impacting biotech clients such as Regeneron.
FDA approval for the idiopathic pulmonary fibrosis drug supported by the pharma company’s FIBRONEER phase III clinical trials.
Pistoia Alliance survey also found that the greatest benefit for lab digitalisation has shifted from efficiency to innovation.
Despite progress from AstraZeneca, Sanofi, Merck & Co, GSK and Pfizer, analysts say effective respiratory syncytial virus treatments are still needed.
The US FDA approvals make the drug the first IL-23 inhibitor to be licensed for two common skin conditions.
The anti-amyloid monoclonal antibody is part of the class of medicines representing the first disease-modifying therapies for the neurodegenerative disease.
The CHMP hands the cancer drug two new recommendations, and the FDA approves its subcutaneous use as Keytruda Qlex.
EMA advisors at the CHMP backed the combination treatment and also recommended Bayer’s menopause drug Lynkuet, putting both on the path to being licensed.
This in-depth focus features articles on cell and gene therapy in Europe and enhancing drug delivery with cost-effective solutions.
In this Guide to Outsourcing article, Doug Botkin, PhD Scientific Portfolio Specialist from Charles River Laboratories, examines how modern microbial ID tools can enhance contamination control strategies and explores the benefits an outsourcing partner can provide.
EPR Issue 3 includes articles on microbiology, downstream processing, manufacturing, drug formulation and more.
The medicine becomes the first EU-approved oral treatment for adults who have postpartum depression (PPD).
The ICH Assembly’s decision supports progress in promoting international standards for safety assessment of medicines.
The innovation is set to change how eligible bladder cancer patients in the US are treated who are unresponsive to traditional therapy.
