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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Moderna strengthens US mRNA manufacturing capabilities with over $140m investment
The expansion places the pharma company’s full manufacturing loop in the US under one roof.
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.
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.
PharmaLab previews new conference tracks ahead of 2025 Düsseldorf event
The pharmaceutical laboratory meeting adds sessions on AI in labs, and quality in biologics, mRNA and analytics.
Italian non-profit set for European gene therapy first in Wiskott-Aldrich syndrome
Fondazione Telethon’s Waskyra (etuvetidigene autotemcel) has been recommended for approval by the CHMP as a treatment for the rare disease.
FDA hits Sarepta with liver warning labelling for its DMD drug Elevidys
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.
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.
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.
CRDMO BioDuro appoints Yaohui Ji as global president for CMC
He joins from contract development and manufacturing organisation Porton Pharma Solutions.
Pharma’s sustainability push continues as Merck signs renewable energy deal
The German pharma company’s agreement for its South Korea sites is the latest green initiative to be unveiled by the industry.
FDA names Dr Richard Pazdur to replace George Tidmarsh as CDER Director
The FDA-veteran and oncology specialist will lead the US drug agency’s work ensuring the safety and efficacy of medicines.
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.
Novartis opens third US radioligand manufacturing facility
California site adds to the Swiss pharma company’s operations in Florida and Texas.
Policy reform call to secure Europe’s antibiotics supply
Supply crisis of antibiotics in Europe adds burden to regional efforts to overcome antimicrobial resistance (AMR), says a new report.
