All Industry news articles – Page 2
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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Industry newsFDA releases new draft guidance on assessing artificial intelligence data
The US Food and Drug Administration (FDA) has released new draft guidance which provides a risk-based credibility framework that can be used for assessing artificial intelligence (AI) data in the drug product lifecycle.
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Industry newsICH releases M15 guideline on model-informed drug development
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) M15 Expert Working Group has developed a draft guideline on model-informed drug development (MIDD) and is now under public consultation.
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Industry newsEC announces evaluation of medical device and IVD regulations
The European Commission (EC) has announced an evaluation of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
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Industry newsIncreased debate over lecanemab
The Lancet has published an editorial encouraging regulators and clinicians to ‘keep an open mind’ about lecanemab, the first drug aimed at slowing the progression of Alzheimer’s disease.
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Industry newsUse of new EMA platform for monitoring medicine shortages to become mandatory
The European Medicines Agency (EMA) has launched the European Shortages Monitoring Platform (ESMP), aimed at preventing and managing shortages of centrally authorised products (CAPs).
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Industry newsGSK Blenrep trial shows ‘significant overall survival benefit’of myeloma treatment
According to a report by GSK, a recent clinical trial has revealed that Blenrep can reduce the risk of death by 42% in multiple myeloma after relapse.
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Industry newsGreater post-market surveillance for medical devices
New draft legislation was laid before the UK Parliament on 21 October 2024 which would require greater post-market surveillance (PMS) for medical devices on the market in Great Britain.
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Industry newsFDA proposes to remove oral phenylephrine in selected drugs
The US Food and Drug Administration (FDA) has released an update proposing the removal of oral phenylephrine as the active ingredient in drugs for treating nasal congestion.
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Industry newsNew cancer drug approved by MHRA
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new drug for non-small cell lung cancer (NSCLC) via a national procedure.
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Industry newsNew guidance for wholesalers and manufacturers following Windsor Framework
The Medicines & Healthcare products Regulatory Agency (MHRA) recently published new regulatory guidance for human medicine wholesalers and manufacturers operating within the United Kingdom (UK).
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Industry newsWHO Pandemic Agreement gains signatories
The President of UNITE signs statement in support of the World Health Organization (WHO) Pandemic Agreement
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Industry newsRegulators publish new guidelines for use of AI
The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) publish new guiding principles for the use of large language models (LLMs) in regulatory affairs.
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Industry newsNew Editor-in-Chief for Regulatory Rapporteur
Victoria Goff has been announced as the new Editor-in-Chief of Regulatory Rapporteur.
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Industry newsWHO issues warning on fake opioids in Europe
The World Health Organization (WHO) has issued an alert that falsified Oxymorphone Hydrochloride has been detected in Finland.
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Industry newsContraindication for mixing weight loss medicine Mysimba with opioids
The European Medicines Agency (EMA) published new advice in July 2024 concerning the combined use of opioid medications and the weight loss drug Mysimba (naltrexone/bupropion).
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Industry newsUK pledges to join the Trans-Pacific Partnership by end of 2024
The UK’s Minister of State for Trade Policy announced on 29 August 2024 that the UK will be joining the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) by 15 December.
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Industry newsNICE and EMA say new Alzheimer’s drug is ‘not recommended’
The new draft guidance from NICE states that Lecanemab is ‘not recommended’ and the EMA has recommended the refusal of the marketing authorisation for Leqembi.