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RSS FeedPosted by Michael Wonder on 19 Jun 2021
European regulator EMA says it won't set 50% efficacy threshold for COVID shots
18 June 2021 - The EMA said on Thursday it would not impose a 50% efficacy threshold for COVID-19 vaccines, ...
Posted by Michael Wonder on 18 Jun 2021
European Commission approves Aubagio (teriflunomide) as the first oral MS therapy for first-line treatment of children and adolescents living with relapsing-remitting multiple sclerosis
18 June 2021 - The European Commission has approved Aubagio (teriflunomide) for the treatment of paediatric patients 10 to 17 years ...
Posted by Michael Wonder on 14 Jun 2021
Vaxzevria: EMA advises against use in people with history of capillary leak syndrome
11 June 2021 - EMA’s safety committee (PRAC) has concluded that people who have previously had capillary leak syndrome must not ...
Posted by Michael Wonder on 11 Jun 2021
International regulators and WHO address need to boost COVID-19 vaccine confidence
11 June 2021 - The International Coalition of Medicines Regulatory Authorities and the World Health Organization have jointly developed a statement ...
Posted by Michael Wonder on 10 Jun 2021
Copiktra (duvelisib) receives European Union marketing authorisation for the treatment of relapsed or refractory CLL and refractory FL
9 June 2021 - Secura Bio today announced that on 19 May 2021, the European Medicines Agency granted marketing authorisation for ...
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 07 Jun 2021
EMA raises awareness of clinical care recommendations to manage suspected thrombosis with thrombocytopenia syndrome
7 June 2021 - EMA’s COVID-19 taskforce (COVID-ETF) is advising health care professionals in the EU to consider recommendations by learned ...
Posted by Michael Wonder on 04 Jun 2021
Advancing international collaboration on COVID-19 real world evidence and observational studies
4 June 2021 - Medicines regulators from around the world discussed the importance of global collaboration and information sharing in relation ...
Posted by Michael Wonder on 03 Jun 2021
EU regulators develop recommendations to forecast demand of medicines
3 June 2021 - The EU Executive Steering Group on Shortages of Medicines Caused by Major Events has adopted a ...
Posted by Michael Wonder on 02 Jun 2021
The economics of alternative payment models for pharmaceuticals
1 June 2021 - Pharmaceuticals are priced uniformly by convention, but vary in their degree of effectiveness for different disease indications. ...
Posted by Michael Wonder on 01 Jun 2021
Additional manufacturing capacity for BioNTech/Pfizer’s COVID-19 vaccine
1 June 2021 - EMA has recommended the approval of additional manufacturing and filling lines at Pfizer’s vaccine manufacturing site in ...
Posted by Michael Wonder on 01 Jun 2021
EMA and EUnetHTA take stock of their co-operation
1 June 2021 - The EMA and the European Network for Health Technology Assessment (EUnetHTA) have published a report on ...
Posted by Michael Wonder on 31 May 2021
New EU health innovation rules edge closer
29 May 2021 - Three years after the original proposal, the European Union’s game changing Health Technology Assessment dossier has ...
Posted by Michael Wonder on 30 May 2021
Diurnal receives European Commission approval for Efmody
28 May 2021 - Commercial launch anticipated in Q3 2021. ...
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 ...