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RSS FeedPosted by Michael Wonder on 20 Jul 2021
EMA starts rolling review of COVID-19 vaccine Vidprevtyn
20 July 2021 - EMA’s CHMP has started a rolling review of Vidprevtyn, a COVID-19 vaccine developed by Sanofi Pasteur. ...
Posted by Michael Wonder on 19 Jul 2021
EMA starts evaluating the use of Kineret in adult COVID-19 patients at increased risk of severe respiratory failure
19 July 2021 - EMA has started evaluating an application to extend the use of Kineret (anakinra) to include treatment ...
Posted by Michael Wonder on 16 Jul 2021
EMA validates BioMarin's marketing authorisation application for valoctocogene roxaparvovec to treat severe haemophilia A
15 July 2021 - Potential first gene therapy in Europe for treatment of haemophilia A. ...
Posted by Michael Wonder on 16 Jul 2021
HutchMed’s marketing authorisation application for surufatinib submitted and validated by the European Medicines Agency
15 July 2021 - EMA commences review of surufatinib for the treatment of advanced neuroendocrine tumours. ...
Posted by Michael Wonder on 02 Jul 2021
Formycon and Bioeq announce submission of the marketing authorisation application for FYB201, a biosimilar candidate to Lucentis (ranibizumab) to the EMA
29 June 2021 - Formycon and its license partner Bioeq AG announce that the marketing authorisation application for FYB201, Formycon’s ...
Posted by Michael Wonder on 29 Jun 2021
Agios submits marketing authorisation application to European Medicines Agency for mitapivat for treatment of adults with pyruvate kinase deficiency
28 June 2021 - Agios Pharmaceuticals today announced that it has submitted a marketing authorisation application for mitapivat to the EMA ...
Posted by Michael Wonder on 29 Jun 2021
BioMarin resubmits marketing authorisation application to European Medicines Agency for valoctocogene roxaparvovec to treat severe haemophilia A
28 June 2021 - Valoctocogene roxaparvovec MAA granted request for accelerated assessment. ...
Posted by Michael Wonder on 29 Jun 2021
Chiasma announces submission of marketing authorisation application for Mycapssa to the European Medicines Agency
28 June 2021 - Submission supported by previously announced data from Phase 3 MPOWERED trial. ...
Posted by Michael Wonder on 28 Jun 2021
Astellas receives positive CHMP opinion for Evrenzo (roxadustat) for adult patients with symptomatic anaemia of chronic kidney disease
25 June 2021 - Astellas Pharma today announced the CHMP of the EMA has adopted a positive opinion relating to the ...
Posted by Michael Wonder on 21 Jun 2021
Bayer submits regulatory applications for oncology treatment combination of copanlisib and rituximab in the U.S. and EU
21 June 2021 - Bayer today announced the submission of a supplemental new drug application to the U.S. FDA and a ...
Posted by Michael Wonder on 08 Jun 2021
Moderna files for conditional marketing approval for its COVID-19 vaccine in adolescents in the European Union
7 June 2021 - Submission based on Phase 2/3 study of mRNA-1273 in adolescents ages 12 to less than 18 ...
Posted by Michael Wonder on 30 May 2021
Calliditas announces submission of marketing authorisation application for Nefecon to the European Medicines Agency
28 May 2021 - Calliditas Therapeutics today announced that the company submitted a marketing authorisation application to the EMA for ...
Posted by Michael Wonder on 20 May 2021
EMA, MHRA to review Vertex' Kaftrio for children with cystic fibrosis
20 May 2021 - The EMA and the MHRA have validated Vertex' applications to expand the scope of its cystic ...
Posted by Michael Wonder on 07 May 2021
EMA starts rolling review of sotrovimab (VIR-7831) for COVID-19
7 May 2021 - EMA’s CHMP has started a ‘rolling review’ of data on sotrovimab (also known as VIR-7831 and ...
Posted by Michael Wonder on 04 May 2021
EMA starts rolling review of COVID-19 vaccine (Vero Cell) inactivated
4 May 2021 - EMA’s CHMP has started a rolling review of COVID-19 Vaccine (Vero Cell) inactivated, developed by Sinovac ...