All Regulatory Rapporteur articles in RegRepPlus 2024
View all stories from this issue.
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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 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 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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Industry newsMelanoma vaccine enters Phase III clinical trials
A personalised mRNA vaccine for a deadly form of skin cancer is being rolled out in an international Phase III clinical trial.
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Industry newsDR Congo mining town sees novel monkeypox strain
A mutation strain of monkeypox has been identified in a mining town in the Democratic Republic of Congo (DRC), according to a preprint paper.
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Industry newsParkinson’s drug slows progression of motor symptoms
A developmental drug has shown promise in slowing symptoms of motor deterioration in people with advanced forms of Parkinson’s.
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Industry newsNovel antibiotic receives EMA’s recommendation
The European Medicines Agency has recommended marketing authorisation for an antibiotic which can treat multidrug-resistant infections.
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Industry newsModified skin bacteria treats tumours in mice
A study from Stanford Medicine has developed a promising method to treat cancer using a type of bacteria which is found on skin.
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Industry newsCutting antibiotic usage reduces resistance levels
Cutting the use of antibiotics in both humans and animals has shown a reduction in antimicrobial-resistant bacteria.
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Industry newsUtah law to permit non-FDA-approved stem cell therapies
Utah has passed legislation that will allow patients to receive placental stem cell therapies without the need for FDA approval.
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Industry newsCholera vaccine shortage puts millions at risk
The World Health Organization has declared a worldwide shortage of the oral cholera vaccine amid an upsurge in cases.