OR WAIT null SECS
July 01, 2020
EMA’s Committee for Human Medicinal Products (CHMP) has recommended that Kaftrio, a triple combination therapy for the treatment of cystic fibrosis, be authorized for marketing in the European Union.
The European Medicines Agency (EMA) and the Ministry of Food and Drug Safety of the Republic of Korea (MFDS) have announced an agreement that will enable the parties to share confidential information on COVID-19 medicines.
The European Medicines Agency (EMA) has recommended a conditional marketing authorization be granted for Idefirix (imlinfidase) for the treatment of highly sensitized adult patients waiting for a kidney transplant.
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.
Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.
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 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.