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June 25, 2020
Novartis UK has issued a statement specifying its disappointment at the initial decision by NICE to not recommend Mayzent (siponimod) for the treatment of secondary progressive multiple sclerosis with active disease.
Emer Cooke, currently the director of the Regulation and Prequalification Department at the World Health Organization (WHO) in Geneva, has been nominated by EMA’s management board to be the new executive director of EMA.
Biotechnology company, ILC Therapeutics, has revealed that it has entered into a research partnership with the University of St Andrews aimed at progressing a therapeutic drug that can treat COVID-19 to clinical trials.
The European Medicines Agency’s (EMA’s) Committee for Human and Medicinal Products (CHMP) has recommended Veklury (remdesivir) be granted conditional marketing authorization in the European Union for the treatment of COVID-19.
June 23, 2020
Members of the European Commission, EMA, and FDA met in a virtual two-day meeting to discuss ongoing joint initiatives and upcoming priorities.
The agency will be waiving fees for scientific advice for academia developing orphan drugs.
June 18, 2020
EMA has issued a press release on June 18, 2020, in which it endorses two statements from the International Coalition of Medicines Regulatory Authorities (ICMRA) about the importance of the safety and effectiveness of vaccines.
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has opened up access to the texts of the European Pharmacopoeia (Ph. Eur.) to support developers of COVID-19 vaccines.
An instruction has been issued to all those performing clinical trials using hydroxychloroquine to treat or prevent COVID-19 to stop recruitment of any new patients by the MHRA in the UK.
June 17, 2020
Cobra Biologics has signed a supply agreement to provide GMP manufacturing for AstraZeneca’s AZD1222 COVID-19 vaccine candidate.