All Pharmacovigilance and safety oversight articles – Page 11
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NewsHDFN 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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ArticleRegulating 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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NewsPersonalised 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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NewsFDA 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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ArticleAlzheimer’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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NewsCHMP 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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NewsPfizer 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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ArticleThe 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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NewsUtilising 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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NewsGeneric 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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ReportPharma 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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ArticleUncovering 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 ...
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NewsEuropean Pharmacopoeia makes milestone pyrogen testing commitment
The "historic" decision from the Ph. Eur. follows publication of its texts relating to the rabbit pyrogen test (RPT) replacement strategy.
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NewsAdvanced techniques fuelling demand for liquid chromatography reagents
The versatility of liquid chromatography is propelling demand for high-quality chromatography reagents, the report stated.
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ArticleUsing rack systems to reduce thermal interactions between vials during freezing
Formulation experts from Polytechnic of Turin, Italy, discuss the impact of freeze-drying on the integrity and stability of pharmaceuticals and how mathematical modelling can improve understanding of the freezing process.
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NewsAbbVie appoints new Chief Scientific Officer
Following the appointment, Thomas Hudson, AbbVie’s current Senior Vice President, Chief Scientific Officer, Global Research, will retire.
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NewsChromatography analysis for nitrosamine quantitation in pharmaceutical manufacturing water
The paper describes an innovative ion chromatography-based analytical method for quantifying nitrite quantities in purified and potable water.
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NewsPharma responds to 2024 UK General Election
The Association of the British Pharmaceutical Industry (ABPI) and Drug Research Safety Unit (DRSU) assert the importance of partnership and collaboration to support the pharmaceutical industry under the new UK government.
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NewsCHMP meeting highlights - June 2024
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended several new medicines, including positive opinions for treatments for rare disorders.
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NewsInnovative small molecule shows promise in obesity
The GLP-1 receptor agonist demonstrated good safety and tolerability in both healthy and overweight/obese adult participants, the Phase I study found.