All news articles – Page 9
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NewsModerna 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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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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NewsPharmaLab 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.
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NewsItalian 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.
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NewsFDA 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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NewsGenetically 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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NewsCRDMO BioDuro appoints Yaohui Ji as global president for CMC
He joins from contract development and manufacturing organisation Porton Pharma Solutions.
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NewsPharma'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.
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NewsFDA 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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NewsRoche’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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Novartis opens third US radioligand manufacturing facility
California site adds to the Swiss pharma company’s operations in Florida and Texas.
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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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NewsAstraZeneca 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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NewsLilly 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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NewsThermally 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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NewsMHRA 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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NewsChiesi completes expansion of French metered dose inhaler facility
The enlarged La Chaussée-Saint-Victor site will serve as a manufacturing hub for the biopharma company.