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EMA recieves CMA application for remdesivir as a COVID-19 treatment europeanpharmaceuticalreview
June 10, 2020
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.
EMA gives positive opinion to investigational Ebola vaccine regimen europeanpharmaceuticalreview
June 09, 2020
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).
EMA to assess conditional authorisation of first COVID-19 treatment in European Union expresspharma
June 09, 2020
The assessment of the benefits and risks of remdesivir is being performed under a reduced timeline and an opinion could be issued within weeks, depending on the robustness of the data submitted.
Global regulatory authorities COVID-19 policy and regulations meeting europeanpharmaceuticalreview
June 04, 2020
Global pharma regulators met to discuss measures to ensure supply continuity, flexible regulatory policies and their expectations for COVID-19 clinical trials.
EMA commissions research in preparation for monitoring COVID-19 vaccines europeanpharmaceuticalreview
May 28, 2020
The research will identify sources of data to monitor coverage and effectiveness, and support pharmacovigilance of COVID-19 vaccines once they are approved.
EMA recommends updating safety information for HRT and leuprorelin europeanpharmaceuticalreview
May 19, 2020
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.
Coronavirus vaccine possible in about a year, says EU agency expresspharma
May 15, 2020
"For vaccines, since the development has to start from scratch ... we might look from an optimistic side in a year from now, so beginning of 2021," said Marco Cavaleri, head of vaccines, European Medicines Agency.
EMA recommends eight drugs for approval from April meeting europeanpharmaceuticalreview
May 08, 2020
The EMA’s human medicines committee has adopted a positive opinion for eight medicines, recommending their marketing authorisation.
EMA to fast-track development of COVID-19 vaccines and therapeutics europeanpharmaceuticalreview
May 08, 2020
The EMA has announced new regulatory changes that will help potential COVID-19 vaccines and therapeutics accelerate through development.
EMA Initiates ‘Rolling Review’ of Remdesivir, Potential COVID-19 Treatment europeanpharmaceuticalreview
May 07, 2020
The EMA’s human medicines committee has announced it has begun a rolling review of remdesivir for the treatment of COVID-19, to examine its safety and effectiveness.

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