All Regulatory Rapporteur articles in RegRepPlus 2024
View all stories from this issue.
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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.
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Industry newsRadio waves used to hijack E.coli bacteria to make medicines
Researchers have developed a method that uses high-frequency radio waves to temporarily open bacterial cell walls to introduce new DNA.
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Industry newsSponge-on-a-string cuts wait time for Barrett’s diagnosis
A procedure to test for a precancerous condition of the oesophagus, which uses a novel medical device, is under trial in NHS England.
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Industry newsMHRA reclassifies codeine linctus as prescription-only
Over-the-counter cough syrups which contain the opioid codeine have been reclassified as prescription-only medicines due to the risk of abuse.
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Industry newsViolin resin works as cleaning agent for ‘superbugs’
A form of resin taken from a Norway spruce has been found to also function as an effective disinfectant against drug-resistant bacteria.
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Industry newsAngioedemas caused by rare gene fault curable by CRISPR
A single dose of a CRISPR gene therapy has been shown to almost eliminate a rare genetic, inflammatory and potentially life-threatening condition.
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CommentaryCell and gene therapy rare disease drug development in the US – general principles, challenges and a landscape of mutual regulatory concession
Cell and gene therapy rare disease drug development in the US – general principles, challenges and a landscape of mutual regulatory concession
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Industry newsEMA platform to monitor use of antimicrobials
All EU member states are required to submit data on sales and use of antimicrobials in animals to the EMA’s new platform.
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Industry newsNHS Pharmacy First offers an alternative to GPs in England
Pharmacists in England can now provide treatment for seven common health conditions without patients first consulting a doctor.
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CommentaryDeveloping a digital people strategy to harness the power of generative AI
Artificial intelligence is a science and applied technology that involves deductive processing and machine learning subsequently performing human-like tasks
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Industry newsAUS-UK joint agency vetmed approval process agreed
The UK’s VMD and Australia’s APVMA have published guidance for the simultaneous review of veterinary medicines submissions.
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Industry newsDisposable vapes set to be banned in Britain by 2025
UK Prime Minister Rishi Sunak has announced a ban on disposable vapes, expected to be enforced in England, Wales and Scotland from 2025.
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Industry news£34m NIHR funding open to researchers from LMICs and UK
The NIHR has announced a new award to help create career opportunities for researchers from low-and middle-income countries and the UK.
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Industry newsNon-surgical gastric balloon to be made available on NHS
A novel gastric ‘balloon’ medical device has been made available on the UK’s National Health Service (NHS) for the first time.
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Industry newsMHRA tightens restrictions on fluoroquinolones
The UK’s MHRA has announced that fluoroquinolone antibiotics can only be prescribed when no other antibiotic is appropriate.