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FDA approves first treatment for rare paediatric genetic diseases
Zokinvy (lonafarnib) capsules have been approved for the treatment of Hutchinson-Gilford progeria syndrome and certain progeroid laminopathies in patients over one year old.
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EMA accepts marketing application for Spinal Muscular Atrophy treatment
The European Medicines Agency (EMA) has accepted the marketing authorisation application for Evrysdi™ (risdiplam) as a treatment of spinal muscular atrophy (SMA).
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COVID-19 rapid antibody tests approved for use in UK
Abingdon Health's COVID-19 rapid antibody test has been registered with the UK's Medicines and Healthcare products Regulatory Agency.
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Experimental motor neurone disease therapy shows promise
Tofersen reduced expression of the SOD1 gene known to cause amyotrophic lateral sclerosis (ALS) and slowed clinical decline in the Phase I/II trial.
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TXA127 enters multiple Phase II trials in COVID-19 patients
A pharmaceutical formulation of the human angiotensin peptide, TXA127, will enter Phase II trials in hospitalised COVID-19 patients not in intensive care.
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Second of Lilly’s COVID-19 neutralising antibodies begins Phase I trials
The first patient has been dosed in the Chinese Phase I trial of JS016 in healthy people who do not have a COVID-19 diagnosis.
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Are thermally stable, ensilicated vaccines the future for childhood inoculations?
Coating the tetanus portion of the DTP vaccine in silica rendered it thermally stable up to 100°C and able to be distributed without refrigeration.
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Potential cytokine storm treatment identified for severe COVID-19 patients
Treating COVID-19 patients with respiratory distress with acalabrutinib, a Bruton tyrosine kinase (BTK) inhibitor reduced inflammation and improved their breathing within three days.
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Simple but effective: an experimental nanoparticle COVID-19 test
Researchers reveal their experimental test can detect the presence of COVID-19 RNA in a sample in 10 minutes, and in a way that does not require trained personnel to interpret.
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CDMO delivers 4,000 doses of COVID-19 vaccine candidate for Phase II/III trial
Advent announced it has manufactured and delivered the first 4,000 doses of the AZD1222 vaccine candidate for the University of Oxford clinical trial.
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COVID-19 vaccine induces immune response in Phase I trial
The adenovirus type 5 vectored COVID-19 (Ad5-nCoV) vaccine candidate safely induced T cell and antibody responses in 108 adults.
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Two malaria vaccine candidates show signs of efficacy
Clinical trials testing potential malaria vaccines report the vaccines were well tolerated and demonstrated some efficacy, delaying Plasmodium falciparum infection.
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Utilising CRISPR could reduce contamination in recombinant-protein drugs
Researchers have used CRISPR-Cas to edit the genes of contaminating proteins in mammalian cells used to produce recombinant-protein drugs, which could reduce costs and strengthen quality.
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Novel antibody delivery method could improve precision medicine
Scientists have developed a protocol for encapsulating antibodies in an ultrasound-sensitive drug carrier for targeted drug delivery.
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QA/QC & Analytical Techniques In-Depth Focus 2020 with a special focus on Chromatography & Microbiology
This in-depth focus highlights how liquid chromatography coupled to mass spectrometry (LC-MS) can be used to characterise proteins, what to do to improve regulatory compliance when using chromatography and the risks posed by underestimating bacterial contaminants in cleanrooms.
