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Two Phase III trials in US to evaluate efficacy of mAbs against COVID-19
Two randomised Phase III clinical trials to test mAbs against COVID-19 are now enrolling healthy adults in the US, the NIH has announced.
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Antibodies
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Interleukin-6 inhibitors improve outcomes for COVID-19 patients in study
Researchers have shown that symptoms in patients experiencing severe COVID-19 improved when given either sarilumab or tocilizumab, interleukin-6 inhibitors.
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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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UK government secures early access to 90 million doses of COVID-19 vaccines
The government has entered partnerships with Pfizer and Valneva to secure doses of several promising COVID-19 vaccines and secured COVID-19 neutralising antibody treatments from AstraZeneca.
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Experimental COVID-19 vaccine mRNA-1273 is safe and elicits response
Interim analysis of the Phase I trial data from 45 patients indicates mRNA-1273 can drive the production of antibodies targeting the SARS-CoV-2 spike protein.
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Phase III COVID-19 antibody trials initiated in Americas
Simultaneous Phase III trials evaluating Regeneron’s REGN-COV2 antibody as both a prophylactic and a treatment have begun in US and some South American locations.
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EMA recommends Idefirix (imlinfidase) is granted marketing authorisation
The European Medicines Agency (EMA) recommended Idefirix is granted conditional marketing authorisation for highly sensitised patients awaiting kidney transplant.
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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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Lilly launches Phase I trial of investigational COVID-19 antibody treatment
The enterprise announced the initiation of the LY-CoV555 COVID-19 antibody treatment trial at medical centres across the US.
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‘At home’ COVID-19 antibody tests: expert opinions and manufacturer warnings
Abbott has revealed its SARS-CoV-2 antibody test was not designed for at home use despite companies selling them for this purpose. Also, what do experts think about these tests?
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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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FDA grants priority review to Biologics License Application for sutimlimab
The FDA has granted priority review of the Biologics License Application for sutimlimab to treat haemolysis in patients with cold agglutinin disease (CAD).
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Under the microscope: Highly potent APIs and toxic payloads
Dr William Sanders discusses trends in the development and manufacture of highly potent active pharmaceutical ingredients (HPAPIs) and toxic payloads for antibody drug conjugates (ADCs).
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SGS’s Centre of Excellence for Biosafety contributes to the fight against coronavirus
Developing new vaccines to fight emerging diseases is an ongoing fight and ensuring they are pure is vital to patients’ health and safety.
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Eli Lilly’s COVID-19 therapies to enter clinical trials
The enterprise announced its drug OLUMIANT® (baricitinib) and an investigational antibody will enter clinical trials in US COVID-19 patients later this month.
