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EMA Endorses Use Of Dexamethasone In COVID-19

The Move Should Speed Up EU National Approvals

 
• By Ian Schofield

Companies marketing dexamethasone in Europe have been told they can use a CHMP endorsement to request the addition of COVID-19 to their product license.

COVID-19 SARS,Coronaviridae , SARS-CoV, SARSCoV, virus 2020 , MERS-CoV ,chinese virus 2019-nCoV
Dexamethasone can be effective in hospitalized COVID-19 patients • Source: Shutterstock

The European Medicines Agency’s drug evaluation committee, the CHMP, has given an opinion endorsing the use of dexamethasone as a treatment option for hospitalized COVID-19 patients who require oxygen therapy.

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The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.

More from Geography

Non-Submissions To UK HTA Body Could Increase Unless Commercial Environment Improves, Warns Industry

 
• By Leela Barham

Finding ways to lower the rebates paid by the pharmaceutical industry to the UK government and fostering partnerships to make the UK a more attractive launch market could help reduce the number of terminated technology appraisals conducted by NICE, the health technology appraisal institute, says the UK pharmaceutical industry.

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PBMs No Longer Profit From Rebates But Plans Benefit; Should Sponsors Push More For Reform?

 
• By Cathy Kelly

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