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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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Drug Development
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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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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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Synthesis and Route Design to Tackle API Complexity
22 July 2024 | By
These longer synthetic pathways present challenges for process chemists hoping to achieve an efficient API manufacturing process.
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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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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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Simplifying complex dosage forms with advanced encapsulation
15 July 2024 | By ACG Worldwide
This webinar explores the unique manufacturing challenges of multi-formulation capsules and how these dosage forms can enhance treatment efficacy and patient compliance.
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Unmasking the unknown: how mass spectrometry delivers accurate identifications
15 July 2024 | By Nelson Laboratories
In this webinar, learn more about advanced techniques like mass spectrometry which can help identify unexpected impurities in drug substances and drug products.
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Advanced 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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AbbVie appoints new Chief Scientific Officer
Following the appointment, Thomas Hudson, AbbVie’s current Senior Vice President, Chief Scientific Officer, Global Research, will retire.
