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, ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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.  ...

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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 ...

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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 ...

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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 ...

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Diurnal receives European Commission approval for Efmody

28 May 2021 - Commercial launch anticipated in Q3 2021. ...

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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 ...

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