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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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Industry Insight
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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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Ipsen agrees new oncology licensing deal
The agreement relates to an innovative therapeutic for the most common paediatric brain cancer, where outside the US, there is no approved targeted treatment for certain patients.
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BeiGene enhances biologic capability with new US facility
Inauguration of the new facility supports BeiGene’s goal to develop affordable and accessible cancer treatments for patients globally.
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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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Securing Europe’s competitiveness in life sciences
Digitalisation, R&D and AMR were highlighted as key areas of focus to support European competitiveness up to the end of the decade, as set out in new Political Guidelines for Europe.
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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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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…
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European 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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Pharma’s attitudes on AI revealed
Artificial intelligence (AI) is generally being embraced in the pharma and life science sectors, but concerns around data accuracy and transparency remain, a new survey reveals.
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Using 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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AbbVie appoints new Chief Scientific Officer
Following the appointment, Thomas Hudson, AbbVie’s current Senior Vice President, Chief Scientific Officer, Global Research, will retire.
