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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.
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Industry newsGene therapy restores hearing in five children
Five children with hereditary deafness have had their hearing restored in both ears through gene therapy in a clinical trial.
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Industry newsCritical need to address mpox strain, says WHO
The World Health Organization (WHO) has warned that it is crucial to address the spread of monkeypox as cases surge.
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Industry newsWHO issues global warning on fake Ozempic medication
The WHO has issued a global alert on falsified semaglutide products used to treat type 2 diabetes and obesity in some countries.
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Industry newsAI used to predict candidate antibiotics in radical study
AI machine learning algorithms have been used in a study to identify candidate compounds for investigation as potential new antibiotics.
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Industry newsFirst human death from H5N2 avian flu recorded in Mexico
The World Health Organization (WHO) has confirmed the first human fatality from H5N2 avian (bird) flu in Mexico.
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Industry newsFDA programme set to improve diversity in clinical trials
The US FDA’s Oncology Center of Excellence has launched an initiative to improve access to clinical trials for under-represented populations.
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Industry newsUnchecked AMR could make COVID-19 pandemic ‘minor’
Professor Dame Sally Davies has warned that unchecked antimicrobial resistance could make the COVID-19 pandemic ’look minor’.
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Industry newsAstraZeneca set to withdraw its COVID-19 vaccine
AstraZeneca has begun withdrawing its COVID-19 vaccine from the market because of greater availability of more up-to-date vaccines.
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