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Janssen-Cilag International

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Latest From Janssen-Cilag International

Diurnal Renames Orphan Drug As Efmody, Expecting EU-Wide Approval

New treatments for congenital adrenal hyperplasia and relapsing forms of multiple sclerosis are among five drugs recommended for pan-EU approval this month. In addition, harmonized EU advice has been issued for Celltrion’s monoclonal antibody COVID-19 treatment.

Europe Drug Review

EU Decision Time On Expanded Use Of BMS/Ipsen Pharma Cancer Drug Combo

The European Medicines Agency may decide this week on a dozen requests by companies seeking new uses of their approved drugs.

Drug Review Approvals

Sputnik V Vaccine Team ‘Working With EMA To Start Rolling Review’

After a few false starts, it seems that the EU regulator has begun preparing the ground for a review of Russia’s adenovirus-based COVID-19 vaccine.

Europe Middle East and Africa

EMA Starts Rolling Review Of CureVac’s COVID-19 Vaccine

CureVac has submitted the pre-clinical data package for its COVID-19 vaccine to the European Medicines Agency, which will be reviewing the data on a rolling basis. 

Coronavirus COVID-19 Europe
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