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2 December 2025 | By Emerson
Join this webinar to discover how the pharmaceutical industry can move towards sustainable autonomous operations by implementing solutions that enhance pipeline acceleration, flexible manufacturing, operational integrity and real-time release.
EPR Issue 4 includes articles on manufacturing, AI/ML, vaccine development, biologics and more.
New BSI standard PAS 2090 could reshape how the pharmaceutical industry reports and minimises its environmental footprint.
Changes proposed in the EU body’s regulatory framework aim to create a competitive and sustainable European bioeconomy.
European approval of Sanofi and Regeneron’s monoclonal antibody provides eligible urticaria patients with a new first-line targeted treatment option.
Authorisation of the biosimilar Gobivaz provides a substitute biologic medicine to Simponi for individuals with immune-mediated diseases.
Oral small molecule treatment Brinsupri (brensocatib) could become a new standard of care for patients with the progressive lung disease.
The approach aims to support broader FDA acceptance of the monocyte activation test (MAT) as a replacement, animal-free pyrogen test.
As well as the new safety warnings for the Duchenne muscular dystrophy gene therapy, the biopharma company also faced a new, more restrictive licence for the treatment.
Decision provides UK Alzheimer’s patients with an alternative administration method for Eisai and Biogen’s antibody drug.
The FDA-veteran and oncology specialist will lead the US drug agency’s work ensuring the safety and efficacy of medicines.
US agency follows in footsteps of European Medicines Agency (EMA) in efforts to streamline biosimilar development.
Approval provides continuity of care into adulthood for patients with neurofibromatosis type 1 (NF1) using Koselugo (selumetinib) to manage symptoms.
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.
