All articles by Catrin Jackson – Page 4
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Industry news
Stakeholder feedback sought on EMA draft clinical guidelines
The EMA has published draft guidance − ICH E6 (R3) − on good clinical practice for clinical trials, which is open for public consultation.
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Industry news
Two paediatric type 2 diabetes oral drugs receive FDA approval
FDA approves Jardiance and Synjardy as treatments to improve the control of blood sugar in children aged 10 years and older, with type 2 diabetes.
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Industry news
NHS to receive £21 million fund for AI diagnostics
NHS Trusts will be able to apply to a dedicated AI diagnostics fund which totals £21 million, the Secretary of State for Health and Social Care announced.
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Industry news
UK and Ireland VetMed product label guidance
Ireland’s HPRA and the UK’s VMD have produced interim guidance clarifying the joint labels for veterinary medicines authorised in the two countries.
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Industry news
Umbrella EU-US VetMed MRA comes one step closer
EU and US make progress towards a mutual recognition agreement for manufacturing inspections of veterinary products.
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Industry news
NICE recommends its first-ever oral migraine treatment
Rimegapant – has been approved for use in the NHS giving a treatment option for people who have failed with different drug options.
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Industry news
MHRA plans medical device technologies streamlined pathway
UK agency aims to make route-to-market much more straightforward for manufacturers with Innovative Devices Access Pathway.
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Industry news
MHRA seals deal for fast international recognition routes
UK agency adopts recognition routes from seven national authorities; new signals start of new international framework for medicines.
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Industry news
Gene therapy gives hope to patients with ‘butterfly skin’
FDA approves first gene therapy to treat dystrophic epidermolysis
bullosa patients – a condition sometimes called ‘butterfly skin’. -
Industry news
Novel gene editing method “roughly threefold” better
Researchers from the University of California Santa Barbara (UCSB) have found two ways to boost the capabilities of CRISPR/Cas9.
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Industry news
FDA licence for first drug to treat agitation in Alzheimer’s
Rexulti has become the first FDA-approved treatment for agitation associated with dementia due to Alzheimer’s disease.
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Industry news
First anaemia drug for cats given ‘expanded conditional approval’
Varenzin-CA1 is the first drug approved for cats with nonregenerative
anaemia, under the FDA’s expanded conditional approval pathway. -
Industry news
FDA approves world’s first RSV vaccine for use in over 60s
A first vaccine, developed by GSK, for respiratory syncytial virus has been approved by the FDA for use in adults aged 60 years and older.
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Industry news
MHRA reappoints two non-exec directors
Two Non-Executive Directors have been reappointed to the MHRA Board effective from September 1, 2023, according to the Department of Health and Social Care.
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