The CHMP has started a “rolling review” of data on a new vaccine for COVID-19, mRNA-1273, which is being developed by Moderna Biotech Spain, S.L.
EMA begins review of Moderna’s mRNA-1273 vaccine
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EMA starts review of BNT162b2 vaccine by BioNTech and Pfizer
EMA’s human medicines committee (CHMP) has started a “rolling review” of data on BNT162b2 vaccine for COVID-19 which is being developed by BioNTech in collaboration with Pfizer.
EMA approves dexamethasone for COVID-19 treatment
Among the candidate treatments, EMA endorses the use of Dexamethasone in COVID-19 patients on oxygen or mechanical ventilation.
The role of big data in healthcare and pharmaceutical regulation
Fondazione Benzi follows with interest the work done at the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) that have recently shared with the community the workplan developed by the Big Data Steering Group.
EMA starts rolling review of AstraZeneca COVID-19 vaccine
The human medicines committee (CHMP) at the European Medicines Agency (EMA) has started the first ‘rolling review’ of a vaccine against COVID-19 that is being developed by AstraZeneca in collaboration with the University of Oxford.
Africa declared wild polio-free: a global health victory
The World Health Organisation certified the WHO African Region now free of the wild poliovirus after four years without a case, moving the world closer to achieving global polio eradication.
Italy’s AIFA approves GRAd-COV2 vaccine trial for covid19
News from Italy! The Italian Medicine Agency (AIFA) approved a phase 1 clinical study on the vaccine GRAd-COV2 produced by ReiThera, an Italian biotech company.
EMA recommends Crizanlizumab for Sickle Cell Disease in adults
The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) gave a positive opinion, recommending the granting of a conditional marketing authorisation for Crizanlizumab (Adakveo®) in patients with Sickle Cell Disease from 16 years of age.
ENCePP guide update on pharmacoepidemiology standards
The eighth revision of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological Standards in Pharmacoepidemiology was published on the ENCePP website.
Fondazione Benzi contributes to the EMA discussion paper on secondary use of data
Fondazione Benzi provided with its contribution to the EMA Discussion Paper “The General Data Protection Regulation: Secondary Use of Data for Medicines and Public Health Purposes”. It is widely acknowledged the huge potential of health data to provide with evidence supporting public health, medicines development and decision-making process across Europe.
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