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EC approves subcutaneous formulation of Remsima®
The European Commission has granted marketing authorisation to Celltrion's Remsima (infliximab, CT-P13) subcutaneous formulation.
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European Medicines Agency (EMA)
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EMA initiates review of dexamethasone for treating COVID-19
The EMA has begun to review dexamethasone to provide an opinion on the results of the RECOVERY study for the treatment of adults admitted to hospital with COVID-19.
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EMA recommends 11 new medicines for approval following July meeting
Dapivirine Vaginal Ring (dapivirine) and Blenrep (belantamab mafodotin) have been recommended for approval by the EMA's CHMP, along with nine other medicines.
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EMA to monitor real world use of COVID-19 treatments and vaccines
The EMA has built up an infrastructure to allow for the monitoring of COVID-19 treatments and vaccines used in clinical practice.
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EMA issues opinion on nitrosamines in medicines
The agency’s opinion will require companies to take measures to reduce nitrosamine impurities in medicines and carry out and action the results of risk assessments.
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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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CHMP recommends cystic fibrosis treatment Kaftrio is granted marketing authorisation
The European Medicines Agency's human medicines committee (CHMP) said the treatment would offer a therapeutic option for certain cystic fibrosis phenotypes that are currently untreatable.
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Comparison of health technology assessments and time to reimbursement for Orphan Drugs
This article delves into four health technology assessment agencies, analysing the opportunities and challenges for orphan drugs in France, Germany, England and Scotland.
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EMA recommends authorisation for remdesivir to combat COVID-19
The EMA's human medicines committee (CHMP) has recommended a conditional marketing authorisation for Veklury (remdesivir) to treat COVID-19.
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EMA issues guidance on medicine impurities, in light of nitrosamine detection
After nitrosamines were detected in sartan medicines, the EMA has released new recommendations about handling and reporting impurities in drugs.
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EMA receives CMA application for remdesivir as a COVID-19 treatment
The European Medicines Agency (EMA) said its assessment of the conditional marketing authorisation (CMA) application will be performed under a reduced timeframe, with a decision potentially delivered in weeks.
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EMA gives positive opinion to investigational Ebola vaccine regimen
Developed by Janssen, the two-dose regimen has already been given to 60,000 patients and now has the positive opinion of the Committee for Medicinal Products for Human Use (CHMP).
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EMA commissions research in preparation for monitoring COVID-19 vaccines
The research will identify sources of data to monitor coverage and effectiveness, and support pharmacovigilance of COVID-19 vaccines once they are approved.
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EMA recommends updating safety information for HRT and leuprorelin
The EMA has suggested that the safety information be updated for HRT, to reflect a higher risk of breast cancer and recommends new measures for the handling of leuprorelin depot medicines.
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COVID-19: the big repurpose and even bigger pharmaceutical partnership
Heidi West discusses how academia, government and the pharmaceutical industry can work together to potentially repurpose drugs for the treatment of COVID-19.
