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Phase III trial to study REGN-COV2, potential COVID-19 antibody treatment
REGN-COV2 will be evaluated alongside standard-of-care in a Phase III study as part of the COVID-19 RECOVERY trial.
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Antibodies
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Phase I trial finds potential COVID-19 antibody treatment safe in healthy volunteers
A first-in-human Phase I clinical trial of potential COVID-19 antibody CT-P59 has shown the treatment is well tolerated in healthy subjects.
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Russia’s Sputnik V COVID-19 vaccine safely elicits an antibody response, reports paper
Preliminary data from Phase I/II trails evaluating the vaccine reveal 100 percent of participants had a humoral and cellular response, with no serious adverse events reported.
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MHRA issues positive opinion to avelumab for Early Access to Medicines Scheme
The UK MHRA has given a positive scientific opinion for Merck and Pfizer's avelumab on the Early Access to Medicines Scheme (EAMS).
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Overview of workflows and data approaches in bioproduction – an industry perspective
Downstream processing is an integral part of the production process of biopharmaceuticals and contributes quite significantly to the overall productivity and product quality, as well as to processing costs. Melanie Diefenbacher of Genedata provides a comprehensive overview of downstream processes, highlighting several challenges and the importance of investing into automation…
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AstraZeneca doses first patients in COVID-19 therapy trial
The Phase I trial will assess the safety and pharmacokinetics of the AZD7442 monoclonal antibody combination in 48 healthy participants.
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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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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.
