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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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Catherine Eckford (European Pharmaceutical Review)
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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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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.
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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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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.
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Lilly bolsters leadership team with neuroscience and immunology in mind
Dr Carole Ho joins from Denali Therapeutics and there are promotions for Adrienne Brown and Daniel Skovronsky.
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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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Lilly boosts oral GLP-1 manufacturing capability with new Netherlands facility
The €2.6 billion manufacturing investment complements the recent US manufacturing expansion for its next potential blockbuster obesity treatment orforglipron.
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MHRA set to overhaul the UK’s rare disease drug regulatory pathway
The medicines regulator will aim to take a more flexible licensing approach for the research and manufacture of rare disease therapies in the UK.
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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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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.
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Sirolimus-eluting balloon offers potential “paradigm shift” in restenosis treatment
Treatment provided a promising alternative to standard care in repeat percutaneous coronary interventions in the first-of-a-kind trial.
