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Innovative vaccine demonstrates sustained malaria immunisation in pregnancy
Follow up research to the presented findings could provide improved opportunities for preventing malaria in women during pregnancy.
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Drug Safety
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First-in-class therapy approved for chronic skin disease
The biologic treatment targets a key driver of prurigo nodularis, with trial data demonstrating improved itch as well as skin nodules for patients with the condition.
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Sustainable QC method for antimicrobial quantification
The new, cost-effective fluorimetric approach could help to mitigate clinical demand for the treatment of multidrug-resistant (MDR) bacterial infections.
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HDFN drug trial shows capability for alloimmune diseases
Based on the new data, nipocalimab could change the standard of care for treating the rare blood disease haemolytic disease of the foetus and newborn (HDFN).
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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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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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CHMP meeting highlights – July 2024
In its July meeting, the EMA’s human medicines committee recommended 14 medicines and held a negative opinion for authorising lecanemab to treat Alzheimer’s disease.
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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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The route to enhanced gene therapies
In this article, Roger Palframan, Head of US Research at UCB, delves into the potential of gene therapy and which modalities have the most promise, what the industry should prioritise to advance the field, as well as what is needed to develop the workforce.
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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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Uncovering the potential of ADCs to target tumours
Antibody drug conjugates (ADCs) are set to play a pivotal role in the future of oncology, thanks to their potential to offer targeted treatments with a lower risk of side effects. Here, Mary Jane Hinrichs, Senior Vice President of Early Development at Ipsen, examines how ADCs could transform treatment options…
