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Blueprint Announces EMA Validation of Type II Variation Marketing Authorization Application for AYVAKYT americanpharmaceuticalreview
March 09, 2021
Blueprint Medicines announced the European Medicines Agency (EMA) has validated the company's Type II variation marketing authorization application for AYVAKYT® (avapritinib) for the treatment of advanced systemic mastocytosis (SM).
EMA and Health Canada to make COVID-19 vaccine data open access europeanpharmaceuticalreview
March 08, 2021
Starting with the publication of clinical data used to support the authorisations of the Moderna COVID-19 vaccine, EMA and Health Canada said they will continue the open access approach for all COVID-19 vaccines.
EMA initiates rolling review of Russia’s Sputnik V vaccine for Covid-19 pharmaceutical-technology
March 05, 2021
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has initiated a rolling review of the Russian Covid-19 vaccine, Sputnik V.
EMA validates Pfizer and OPKO’s somatrogon marketing application for review pharmaceutical-business-review
March 04, 2021
The European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for Pfizer and OPKO’s somatrogon, for review.
Idorsia submits investigational insomnia treatment daridorexant to the EMA pharmatimes
March 03, 2021
Swiss biotech company Idorsia has submitted a marketing authorisation application to the European Medicines Agency (EMA) for its investigational insomnia treatment daridorexant.
EMA issues its requirements for adapting COVID-19 vaccines for viral variants europeanpharmaceuticalreview
March 01, 2021
The European Medicines Agency has set out its guidelines for vaccine manufacturers adapting their approved COVID-19 vaccines to combat viral variants.
EMA begins review of Celltrion’s antibody data for Covid-19 treatment pharmaceutical-technology
February 26, 2021
The human medicines committee (CHMP) of the European Medicines Agency (EMA) has initiated a rolling review of data on Celltrion’s monoclonal antibody regdanvimab (CT-P59) for Covid-19 treatment.
CureVac’s COVID-19 vaccine begins rolling review with EMA pharmatimes
February 19, 2021
German biopharmaceutical company CureVac has announced the initiation of a rolling review with the European Medicines Agency (EMA) for its mRNA-based COVID-19 vaccine, CVnCoV.
Janssen-Cilag seeks EMA authorisation for Covid-19 vaccine candidate pharmaceutical-technology
February 19, 2021
Johnson & Johnson’s (J&J) Janssen-Cilag International has announced it applied to the European Medicines Agency (EMA) to obtain authorisation for its Covid-19 vaccine candidate.
EMA initiates rolling review of Regeneron’s COVID-19 mAb europeanpharmaceuticalreview
February 03, 2021
The EMA’s CHMP has begun a rolling review of REGN-COV2, Regeneron’s COVID-19 antibody candidate, after successful pre-clinical trials.

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