All news articles – Page 70
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NewsMonoclonal antibody could prevent malaria, study shows
Based on recent research, a "potential game changer” approach could offer a practical way to use monoclonal antibody therapies for malaria in Africa.
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NewsEli Lilly to help fund cold chain initiative
$1.15m funding from Eli Lilly and Company will support a new cold chain capacity initiative in low- and middle-income countries, to help improve medicine access.
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NewsNew UK point of care manufacturing regulatory framework
A first-of-its-kind regulatory framework for point of care manufacturing of innovative medicines is set to be introduced in the UK, ensuring these products are as safe as conventional medicines.
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NewsEnhertu approved in EU for HER2-low breast cancer
The European Commission has approved Enhertu in the EU as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer.
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NewsFirst CAR T-cell therapy recommended on NHS
NICE’s recommendation of Yescarta® means it is the first time patients will be able to access CAR T-cell therapy long-term on the NHS.
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NewsEMA publishes updated Q&A for ICH M10
An updated Q&A document for ICH M10 'Bioanalytical Method Validation and Study Sample Analysis’ has been published by the European Medicines Agency (EMA).
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NewsWHO urges supply chain to take action on contaminated medicines
Key stakeholders in the medicine supply chain have been urged by the World Health Organization to take immediate action against recent cases of contaminated medicines.
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NewsMajor study on DMT shows promise for depression
One of the largest studies for a short-acting psychedelic showed a remission rate of 57 percent for major depressive disorder after a single dose of DMT.
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NewsEMA validates first regulatory submission for CRISPR-based medicine
The first regulatory submission for a CRISPR-based therapy has been validated by the European Medicines Agency, to treat sickle cell disease and transfusion-dependent beta thalassemia.
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NewsLargest global clinical site hires all-female key leaders in Europe
Three all-female key leaders in Europe have been hired by Velocity Clinical Research, the largest clinical sites business globally.
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NewsTakeda to license potential treatment for colorectal cancer
Takeda and HUTCHMED have entered into an exclusive licensing agreement, to develop tyrosine kinase inhibitor fruquintinib for colorectal cancer outside China.
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NewsOnivyde® improves survival in Phase III pancreatic cancer trial
Onivyde® (irinotecan liposome injection) treatment regimen significantly improved survival in a Phase III trial compared to nab-paclitaxel plus gemcitabine.
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NewsEU antibiotic shortages being monitored by MSSG
The Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) have stated it is closely monitoring and responding to the current EU antibiotic shortages.
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NewsPersonalised cancer immunotherapy granted fast track designation
The FDA has granted fast track designation for Evaxion’s personalised cancer vaccine in combination Keytruda® for patients with metastatic melanoma.
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NewsLimiting microbial hazards in inhaled cannabis products
FDA researchers found there was some reduction in microbial counts by heating cannabis with a commercial vaporiser to limit microbial contamination, but they were not statistically significant.
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NewsFDA issues complete response letter for donanemab
A complete response letter for Eli Lilly's accelerated approval submission of donanemab for early Alzheimer's has been issued by the US Food and Drug Administration (FDA).
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NewsMHRA authorises BRUKINSA® in Great Britain for two cancers
BRUKINSA® (zanubrutinib) has been authorised by the MHRA for chronic lymphocytic leukaemia and marginal zone lymphoma in Great Britain.
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NewsClinical trial-first for liver cancer immunotherapy combo
IMbrave050 is the first Phase III study to show a cancer immunotherapy combo reduced risk of disease recurrence for early-stage hepatocellular carcinoma.
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NewsAmgen commits $8m to clinical trial diversity programme
The Robert A. Winn Diversity in Clinical Trials Award Program has been pledged $8 million over the next four years by Amgen.
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NewsNICE recommends all-oral treatment for multiple myeloma
Ninlaro® (ixazomib) plus lenalidomide and dexamethasone has been recommended by NICE for relapsed/refractory multiple myeloma patients who have had two or three lines of therapy.