All articles by Rebecca Harding
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Industry newsEFPIA publishes guidance document to help support novel methodology submissions
This industry news update shares the EFPIA’s guidance document to help support the submission process for novel methodologies.
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Industry newsNew Director appointed at the FDA’s Center for Drug Evaluation and Research
This industry news update discusses George Francis Tidmarsh, M.D., Ph.D., who has been appointed as Director of the Center for Drug Evaluation and Research.
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Industry newsFDA makes labelling changes to opioid products mandatory
This industry news update shares the FDA’s labelling requirements for opioid products and what changes must be applied.
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Industry newsEMA and ICH call for more real-world evidence in regulatory practices
This industry news update explores the growing need for more real-world evidence and real-world data.
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Industry newsEMA publishes workplan on how to harness data and AI for public health
This industry news update discusses the EMA’s workplan on how to use data and AI to improve public health.
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Industry newsNICE rejects funding for Lecanemab as treatment benefits ‘remain too small’
The National Institute for Health and Care Excellence (NICE) has recently announced that it will not back funding for the Lecanemab due to concerns about its effectiveness.
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Industry newsNHS app opens access to trials for UK patients
This industry news update looks at the NHS app and the opportunities for patients to take part in clinical trials.
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Industry newsUpdated post-market surveillance requirements take effect
This industry news update looks at the MHRA’s new PMS requirements for medical devices that took effect on 16 June 2025.
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Industry newsFDA to replace animal testing with new approach methodologies
The US Food and Drug Administration (FDA) has announced plans to replace animal testing for monoclonal antibodies (MABs).
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Industry newsEMA to address antimicrobial resistance risks from veterinary medicinal products
The European Medicines Agency (EMA) has published a new concept paper outlining plans to assess the risks of humans developing AMR from VMPs via the environment.
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Industry newsMHRA provides guidance to streamline safety communication
The Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on safety communications to ensure that medicines, medical devices and other healthcare products reach ‘high standards of safety, quality and efficacy.’
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Industry newsRui Santos Ivo elected as new Chair of the EMA Management Board
Rui Santos Ivo has been elected as the new Chair of the European Medicines Agency (EMA) Management Board. Mr Santos Ivo takes over from Lorraine Nolan, who completed her tenure on 21 March 2025.
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Industry newsUK life science sector calls for more diverse workforce skills to secure future growth
To deliver cutting-edge treatments and revolutionise patient outcomes, the future life sciences sector workforce must be equipped with skills ranging from advanced scientific expertise, digital proficiency and AI-driven problem solving, according to a newly published report.
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Industry newsMHRA appoints new Chief Executive Officer
Lawrence Tallon has been appointed the new Chief Executive Officer at the Medicines and Healthcare products Regulatory Agency (MHRA) and will begin the role on 1 April 2025.
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Industry newsMHRA approves Nemolizumab for eczema patients in the UK
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Nemolizumab, also known as Nemluvio, to help with the treatment of atopic dermatitis (eczema) in the UK.
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Industry newsEMA establishes new standard procedure for high-risk medical devices
The European Medicines Agency (EMA) has established a standard procedure for manufacturers of high-risk Class III and Class IIb medical devices to request scientific advice.
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Industry newsEMA accepts new guidelines on investigational ATMPs
The European Medicines Agency (EMA) has adopted the Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials, which officially comes into effect on 1 July 2025.
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Industry newsPharmacies told to follow GPhC guidance on prescription-only weight-loss medicine
Online pharmacies in England, Scotland and Wales are required to follow updated guidance from the General Pharmaceutical Council (GPhC), after concerns that prescription-only medicines (POM) for weight loss are being inappropriately supplied.
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Industry newsMHRA issues guidance on post-market surveillance regulation in Great Britain
The Medicines and Healthcare products Regulatory Agency (MHRA) has published The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: guidance on implementation
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Industry newsFDA releases new draft guidance on assessing artificial intelligence data
The US Food and Drug Administration (FDA) has released new draft guidance which provides a risk-based credibility framework that can be used for assessing artificial intelligence (AI) data in the drug product lifecycle.