All Regulatory Rapporteur articles in RegRapPlus 2023
View all stories from this issue.
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Industry news
US could ‘seize’ drug patents with unused Reagon-era law
The Biden administration sets new policy direction that could see the US federal government ‘seizing’ patents from publicly-funded medicines.
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Industry news
First three countries added to WHO-Listed regulatory agencies
Singapore, the Republic of Korea and Switzerland are the first three countries to receive the status of WHO-Listed Authorities.
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Industry news
Probiotic can boost immunity in children, study findings show
In a pre-clinical study, a probiotic bacteria has been found to boost immunity in newborn babies when given to the mother during pregnancy.
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Industry news
MHRA eligibility checker launched for IRP framework
The MHRA has launched an online eligibility checker tool for applications submitted via its International Recognition Procedure (IRP).
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Video
Australian PM makes thalidomide apology on 62nd anniversary
Survivors of thalidomide receive national apology from Australian parliament − “One of the darkest chapters in Australia’s medical history”
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Industry news
CRISPR tool used to treat sickle-cell and β-thalassemia
Casgevy is the first gene therapy that uses the CRISPR/Cas9 gene-editing tool to be approved by the UK MHRA.
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Industry news
Researchers aim to diagnose Alzheimer’s through blood test
The Blood Biomarker Challenge will aim to determine if a blood test could be used to diagnose people in the early stages of Alzheimer’s disease.
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Industry news
J&J to submit trial application for surgical robot
Johnson & Johnson’s MedTech division is set to submit its robotic surgical system to the FDA in order to initiate clinical trials.
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Industry news
Cyber risk standard gets FDA backing for medical devices
The FDA has encouraged the use of a consensus standard to help device manufacturers address growing concerns over cyber security in devices.
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Video
ICMRA regulators to mark its 10th year at event in Australia
International Coalition of Medicines Regulatory Authorities set to celebrate 10 years of strategic leadership at Melbourne summit.
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Industry news
WHO endorses use of R21/Matrix-M malaria vaccine in children
The World Health Organization (WHO) has recommended widespread use of the R21/Matrix-M malaria vaccine in children.
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Industry news
SARS-CoV-2 can cause brain damage in dogs, says study
SARS-CoV-2 can cause changes to the brains of dogs, according to a study published in the CDC’s journal Emerging Infectious Diseases.
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Industry news
Patients warned about falsified Ozempic medication
The EMA has warned patients and healthcare professionals across the EU about pre-filled injection pens falsely labelled as Ozempic.
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Industry news
MHRA seeks to cut approval time by 50% for ‘lowest-risk’ RCTs
The MHRA is set to introduce a new scheme which aims reduce the time taken by the agency to approve the lowest-risk clinical trials.
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Industry news
FDA to establish Digital Health Advisory Committee
The FDA has established a Digital Health Advisory Committee to help the agency explore issues related to digital health technologies (DHTs).
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Industry news
South Africa set to investigate J&J over MDR-TB drug pricing
Johnson & Johnson is set to be investigated by South Africa’s Competition Commission for its prices charged for TB drug bedaquiline.
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Industry news
EMA proposes novel method to assess CKD therapy efficacy
Glomerular filtration rate slope can be used as a surragate end point to assess clinical benefit for treatments in CKD in some trial settings.
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Industry news
NICE recommends AI to aid radiotherapy treatment in England
First guidance from National Institute for Health and Care Excellence for use of artificial intelligence as tool for healthcare professionals.
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Industry news
NICE approves use of Rimegepant in NHS to treat acute migraine
Rimegepant is the first, and only, NICE-recommended treatment for acute migraine and is soon to be made available on the NHS in the UK.
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Industry news
FDA committee finds OTC decongestants to be ‘ineffective’
An FDA committee has reviewed phenylephrine − the active ingrediant in many over the counter decongestants − and agreed it is ineffective.