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Chiesi gains pace on climate target with new carbon minimal inhaler data
Findings presented at the British Thoracic Society (BTS) Winter Meeting back biopharma’s Net Zero commitment.
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Research & Development (R&D)
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Dupixent receives first-in-decade EU approval in chronic spontaneous urticaria
European approval of Sanofi and Regeneron’s monoclonal antibody provides eligible urticaria patients with a new first-line targeted treatment option.
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Insmed wins first EU approval for non-cystic fibrosis bronchiectasis treatment
Oral small molecule treatment Brinsupri (brensocatib) could become a new standard of care for patients with the progressive lung disease.
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Internationally-compliant framework backs rabbit pyrogen test alternative
The approach aims to support broader FDA acceptance of the monocyte activation test (MAT) as a replacement, animal-free pyrogen test.
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Johnson & Johnson targets oncology portfolio with $3bn Halda acquisition
Acquisition of the US biotech gives Johnson & Johnson rights to clinical-stage precision treatments for solid tumours.
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MHRA approves Leqembi IV maintenance as additional Alzheimer’s option
Decision provides UK Alzheimer’s patients with an alternative administration method for Eisai and Biogen’s antibody drug.
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Genetically engineered iPSCs see clinical-scale platelet manufacturing potential
By utilising patient-derived instead of donor-derived platelets, the method could offer a safer approach to platelet transfusions.
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Roche’s fenebrutinib shows best-in-disease potential in multiple sclerosis
Phase III data suggest the drug could be the first high-efficacy, oral therapy for relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis.
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Thermally driven chemical reaction shows drug manufacturing promise
The “simple” approach for initiating electron transfer reactions could enable synthesis of small molecule drugs, researchers say.
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MHRA selects Prof Jacob George as its first Chief Medical and Scientific Officer
The cardiovascular expert will head the UK medicines regulator’s science and innovation strategies.
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Pfizer and Novo Nordisk battle for obesity market dominance
Novo Nordisk’s “bold” $6.5 billion bid subject to a final verdict by Metsera’s board of directors.
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FDA draft guidance on biosimilars offers “regulatory relief”
US agency follows in footsteps of European Medicines Agency (EMA) in efforts to streamline biosimilar development.
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Raman-based PAT tool could advance continuous vaccine manufacturing
Study demonstrates the non-invasive tool’s potential for real-time monitoring of cytomegalovirus (CMV) viral particles.
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AI expert warns pharma industry: artificial intelligence is a competitor, not just a tool
Speaking at CPHI Frankfurt, Bruno Fabre underlined the importance of companies viewing the technology as a fundamental business capability, rather than “an afterthought”.
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Lilly AI factory to accelerate pharmaceutical manufacturing and development
Pharma giant plans to harness its “decades of data” and use AI to set a new scientific standard that accelerates pharmaceutical innovation.
