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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.
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Biopharma
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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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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.
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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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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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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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Pfizer’s Metsera hunger sees it beat Novo Nordisk’s obesity biopharma offer
The deal puts Pfizer’s plans to acquire the US firm, and a portfolio that includes injectable GLP-1 drugs, back on track.
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AstraZeneca seals obesity deal as Pfizer-Novo Nordisk battle for Metsera
After Wegovy and Zepbound's success, competition for the next potential weight loss blockbuster heats up.
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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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Galapagos set for small molecule and biologics pivot after cell therapy exit
But the Belgium biotech’s decision to winddown the cell business will cause it to cut around 90 percent of its headcount.
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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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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.
