All articles by Catrin Jackson – Page 2
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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.
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Industry newsDevice which can detect skin cancer approved by FDA
The FDA has approved a wireless hand-held device that uses an artificial intelligence-powered algorithm to detect skin cancer.
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Industry newsMHRA workplan to support safe access to medtech
The MHRA has published a two-year workplan which will see the introduction of a range of new regulations for medical devices in the UK.
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Industry newsEMA set to host psychedelics uses workshop in April
The EMA will host a workshop to discuss the therapeutic potential of psychedelic substances to address unmet medical need.
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Industry news3D-printed device could reduce need for animal testing
A 3D-printed device is able to determine the effects of drugs on the human body and could help reduce the need for testing drugs in animals.
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Industry newsNon-hormonal menopause drug approved in UK
The MHRA has authorised a non-hormonal medicine, Veoza, which targets a protein in the brain to stop vasomotor symptoms in menopause.
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Industry newsEMA/HMA publish workplan for the responsible use of AI
The EMA and the HMA have published a multi-annual AI workplan 2023-2028 to facilitate the safe and effective use of artificial intelligence.
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Industry newsMHRA’s IRP pathway now open for new medicines approvals
Medicines manufacturers can now submit marketing authorisation applications via the MHRA’s International Recognition Procedure.
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Industry newsProbiotic 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 newsMHRA 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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Industry newsCRISPR 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 newsResearchers 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 newsCyber 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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VideoICMRA 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 newsWHO 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 newsSARS-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 newsPatients 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 newsMHRA 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 newsFDA 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 newsEMA 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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