More news – Page 7
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Industry newsMHRA 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 newsMHRA 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 newsIllegal vapes found to contain lead and nickel: TOPRA Fellow
Inter Scientific - founded by TOPRA Fellow David Lawson - tests vapes confiscated from school children as part of BBC News investigation.
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Industry newsGene 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 newsHIV-prevention drug is first to be made in South Africa
Indian firm Cipla is first manufacturer approved to produce generic of the HIV-preventer cabotegravir, in South Africa.
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Industry newsNovel 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 newsChanging of the guard at Regulatory Rapporteur
Leslie Dowling, Editor-in-Chief of the Regulatory Rapporteur, for 12 years steps down:
Davina Stevenson set to take on lead of respected journal. -
Industry newsFDA 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 newsFirst 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 newsFDA 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 newsWHO says COVID-19 ‘no longer a global health emergency’
SARS-Cov-2 – which caused the COVID-19 pandemic – “no longer a public health emergency of international concern”: WHO.
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Industry newsMHRA 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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Industry newsIndia backs ambitious expansion in spending to support medical devices
India’s seeks to cut its dependence on imports of medical devices.
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Industry newsModerna secures agreement for mRNA facility in Kenya
Moderna has finalised an agreement with the Government of the Republic of Kenya to build an mRNA-specific facility in Kenya which will eventually be capable of producing up to 500 million doses of vaccine per year.
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Industry newsGhana approves R21 malaria vaccine; first to exceed WHO’s efficacy target
The vaccine will be called Matrix-M™
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Industry newsEU seeks to boost innovation ahead of future pandemics
Following the impact of the COVID-19 pandemic, an EU-funded team has created an online platform for the development of diagnostic, prevention and surveillance technologies for emerging novel diseases.
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Industry newsHow AI can find your best drug match
Artificial intelligence-driven technology developed by Genetika+ can match antidepressant drugs to patients to make sure the prescribed drug works as well and better avoid unwanted side effects.
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Industry newsFDA-approved drug shows promising results for itching condition
Patients with notalgia paresthetica – a nerve disorder characterised by a persistent itch in the upper back – could potentially get relief with oral difelikefalin, according to a new study published in the New England Journal of Medicine.
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Industry newsDuchenne Muscular Dystrophy research receives EMA support
The EMA has published a letter of support for the Duchenne Regulatory Science Consortium’s (D-RSC) Clinical Trial Simulation Platform (CTSP) for Duchenne Muscular Dystrophy (DMD) treatments.
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Industry newsMHRA cell therapy research evaluates immune-stimulant cancer therapies
MHRA cell therapy research is evaluating two different approaches to cancer therapies in order to secure reduction in side effects for patients.