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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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Clinical Trials
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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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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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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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AbbVie 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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Lilly agrees $3.2b IBD acquisition
The acquisition, which has a value of approximately $3.2 billion, is set to support development of small molecule oral integrin therapies for conditions such as ulcerative colitis.
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‘Accidental’ media switch leads to CAR T therapy discovery
The investigators hope that their new approach could lead to large-scale manufacturing of the CAR T cells for blood cancer patients.
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CHMP 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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Innovative 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.
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Application note: Validating recombinant cascade reagents in 3 simple steps
Endotoxin testing continues to evolve alongside the industry’s need for more sustainable methods that reduce ecological impact. Nicola Reid, Associate Director of Endotoxin Products, Charles River Labs, reflects on these developments which are driven by the 3Rs (replacement, reduction and refinement).
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European Pharmaceutical Review Issue 3 2024
European Pharmaceutical Review Issue 3 includes articles on microbiology, downstream bioprocessing and drug development. Register your details now to download this exclusive content.
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New draft guidance promotes diversity in clinical trials
FDA’s new draft guidance follows the new requirement for clinical study sponsors to submit Diversity Action Plans, eg, when submitting their investigational new drug (IND) application.
