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EDQM releases new guidelines for COVID-19 vaccine quality testing
The European Directorate for the Quality of Medicines & Healthcare has announced three new guidelines outlining how to test the quality of COVID-19 vaccines.
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Oxford COVID-19 vaccine triggers robust immune response in older adults, study shows
The University of Oxford and AstraZeneca COVID-19 vaccine candidate is effective in healthy adults aged 56-69 and those over 70 years of age, a Phase II study has demonstrated.
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Digital agility and customer-centricity – imperatives for Medical Affairs in a post-COVID world
Mary Alice Dwyer and Sameer Lal explain how pharmaceutical companies can embrace a more customer-centric approach through digital transformation.
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BNT162b2 vaccine is 95 percent effective against COVID-19, finds final efficacy analysis
The concluded Phase III study of BNT162b2 met all primary efficacy endpoints, with a consistent 95 percent efficacy across all patient populations.
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Drug Safety Research Unit says repurposed drugs for COVID-19 still require a lot of testing
The DSRU said that global collaboration would be required to successfully expedite the necessary safety and efficacy evaluations for repurposed drugs to be used in COVID-19 patients.
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COVID-19 is benefiting contract manufacturing services, suggest reports
Reports have found that the COVID-19 pandemic is providing new opportunities for contract and development manufacturing organisations (CDMOs).
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J&J initiates second Phase III trial of COVID-19 vaccine candidate
J&J has initiated a global Phase III clinical trial to study JNJ-78436735, a vaccine candidate for the prevention of COVID-19.
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EMA releases safety monitoring plan for COVID-19 vaccines
The EMA's safety monitoring plan outlines how new information after authorisation of COVID-19 vaccines will be collected and reviewed.
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EMA initiates rolling review of Moderna’s COVID-19 vaccine
The rolling review will shorten the approval timeframe by evaluating data on the safety, efficacy and quality of the mRNA-1273 vaccine as it becomes available.
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WHO lists first vaccine for emergency use
The nOPV2 vaccine has received emergency use listing and will be used to combat outbreaks of circulating vaccine-derived polio viruses (cVDPVs).
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Fluvoxamine may prevent severe COVID-19 onset, suggests trial
Researchers say the promising results warrant larger trials evaluating fluvoxamine as a potential intervention to prevent COVID-19 patients developing severe symptoms.
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Moderna’s COVID-19 vaccine is 94.5 percent effective, according to interim analysis
The analysis reveals that mRNA-1273 was generally well tolerated and prevented COVID-19 with an efficacy of 94.5 percent in a Phase III study.
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First COVID-19 patient dosed in Phase II trial of Quellor
The first patient has been dosed with Quellor in a Phase II clinical trial, evaluating the drug for the treatment of pulmonary complications from COVID-19.
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Clinical trial disruptions: is it all down to COVID-19?
This article explores how COVID-19 has impacted clinical investigation sites and what companies could do to mitigate the effect on trials moving forwards.
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Russia’s Sputnik V COVID-19 vaccine candidate shows promising results, report says
Russia’s Sputnik V, a potential COVID-19 vaccine, was 92 percent effective at protecting people from the coronavirus, interim results have shown.
