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Regulating therapies for rare diseases – recent approvals
This article summarises some of the recent notable drug approvals in the EU and US, including a gene therapy and an enzyme replacement therapy.
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Personalised mRNA cancer therapy shown to boost immune response
The individualised neoantigen therapy could enable a precise, durable immune response, based on study findings in melanoma and lung cancers.
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Genentech-Sangamo deal to advance neurodegenerative treatments
Overall, Sangamo Therapeutics will be eligible up to $1.9 billion from Genentech, which includes various milestone and royalty payments.
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Downstream process shows potential for oncolytic virus purification
The paper presents an “efficient and scalable GMP-compliant process” for purifying a fusogenic oncolytic virus (rVSV-NDV).
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FDA approves innovative engineered cell therapy
The accelerated approval by the US Food and Drug Administration (FDA) authorises the first engineered cell therapy for a solid tumour in the US.
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Alzheimer’s drug development roundup – July 2024
From exciting data on cell therapy and monoclonal antibodies, through to new regulatory developments, this article summarises some of the key developments within the Alzheimer’s therapeutic landscape over July.
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Achieving VLP continuous production with digital twins
Utilising a digital twin for an advanced process control strategy facilitates additional productivity gains of 20 percent at 99.9 percent reliability, the authors shared.
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From biologics to small molecules – the shift in biopharma’s revenue growth
Biopharma companies that experienced strong revenue growth due to COVID-19 drug sales have been overtaken by companies that developed obesity drugs in 2023, GlobalData suggests.
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Eco HPLC-based method shows promise for Z-alkene synthesis
The innovative method, which utilises continuous closed-loop recycling of samples, could lead to a more environmentally-friendly approach to developing pharmaceuticals.
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Pfizer receives EU haemophilia B gene therapy approval
The single-dose gene therapy was approved for certain patients with haemophilia B in the US and Canada earlier this year, marketed as BEQVEZ.
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Utilising naturally occurring endotoxins in recovery studies
The research aimed to address concerns from regulatory agencies about accepting low endotoxin recovery studies that use a naturally occurring endotoxin analyte.
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Generic HIV raltegravir medicines approved
The UK Medicines and Healthcare products Regulatory Agency (MHRA)’s novel approval means that certain patients with HIV have more options for treatment.
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Pharma Horizons: Formulation
European Pharmaceutical Review's latest Pharma Horizons report provides insight on key developments within pharmaceutical drug formulation for drug development, pharmaceutical manufacturing and quality control.
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UK needs RNA workforce “fit for the future”
The report insists that to take advantage of the expected surge in RNA-based therapeutics, it is imperative to secure a sufficiently trained workforce in the UK.
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Innovative chromatography method shows sustainability potential
The twin-column recycling approach helps to minimise the environmental impact of traditional purification methods for high-value molecules, research suggests.
