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NaviFUS begins clinical trial for brain tumour treatment
NaviFUS® was approved by the Taiwan FDA for use in a new clinical trial for the treatment of terminal primary brain tumours.
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Clinical Trials
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FDA Fast Track designation given to mRNA RSV vaccine
Moderna’s mRNA respiratory syncytial virus (RSV) vaccine candidate, mRNA-1345, gains Fast Track designation in adults over 60 years old.
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Baricitinib reduces mortality of hospitalised COVID patients by 46 percent
New data shows Lilly’s Olumiant (baricitinib) significantly reduces the risk of death in hospitalised COVID-19 patients receiving invasive mechanical ventilation or ECMO.
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Saphnelo approved to treat systemic lupus erythematosus
AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for patients with moderate to severe systemic lupus erythematosus.
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AstraZeneca reveals $15.54 billion in revenues in H1 2021
H1 financial results show AstraZeneca’s revenues grew by 23 percent in 2021, with $14.37 billion attributed to activities aside from COVID-19 vaccine sales.
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FDARA implementation guidance for paediatric studies of molecularly targeted oncology drugs
This article addresses early planning for paediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original New Drug Application (NDAs) and Biological License Application (BLAs) are expected to be submitted to FDA, in accordance with The FDA Reauthorization Act (FDARA).
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Camostat cuts recovery time in half for mild COVID-19 patients
Phase II trial results suggest Daewoong Pharmaceutical’s Foistar (Camostat mesilate) may significantly expedite recovery from mild COVID-19 symptoms.
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Roche’s Evrysdi significantly improves lives of babies with SMA
The Phase II study of Evrysdi showed significant improvements in survival and motor milestones in babies with type 1 spinal muscular atrophy (SMA).
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FDA approves first interchangeable biosimilar insulin product
The first interchangeable biosimilar insulin product will help increase access and affordability of insulin for diabetics.
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Alzheimer’s treatment lowers tau by nearly 50 percent in Phase I trials
Biogen and Ionis announced positive topline data on investigational Alzheimer’s treatment, indicating 50 percent tau protein reduction.
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Genomic sequencing is a potential key to precision medicine for cancer
A new US study demonstrated that comprehensive genomic sequencing is crucial for the development of precision medicine for cancer patients.
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Regulators call for clinical research to include pregnant and breastfeeding women
The FDA and other global regulators are co-operating to address inadequacies in clinical research that leave pregnant and breastfeeding women lacking data on which to base their medical decisions.
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EMA recommends approving Spikevax COVID-19 vaccine for adolescents
Based on new clinical results, the EMA is recommending Moderna’s Spikevax COVID-19 vaccine be approved for use in children aged 12 to 17 years.
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AI and big data will continue to disrupt pharma sector, says survey
A GlobalData report has revealed the extent to which companies will be using AI and big data in drug discovery and development processes.
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New targeted gene therapy could reverse neurological diseases
Researchers have developed a novel gene therapy that could help treat children with incurable genetic and neurodegenerative diseases.
