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July 01, 2020
The European Investment Bank (EIB) in partnership with the European Commission (EC) have pledged an additional EUR 4.9 billion (US $5.5 billion) to be used in the global coronavirus response funds.
Investigating the root causes of OOS conditions, product defects, and batch failures requires a systematic, thorough approach.
Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.
June 30, 2020
The guidance document provides recommendations regarding data needed for the manufacturing, development, and approval of a COVID-19 vaccine.
June 26, 2020
FDA is placing emphasis on developing guidance documents more quickly and efficiently, and agency officials expect that such approaches may continue in the future.
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.
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.