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EMA initiates rolling review of Valneva’s COVID-19 vaccine (VLA2001)
EuropeanPharmaceuticalReview
December 06, 2021
The European Medicines Agency (EMA)’s human medicines committee (CHMP) has begun a rolling review of VLA2001, a COVID-19 vaccine being developed by Valneva...
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EMA receive marketing authorisation application for molnupiravir
PharmaTimes
November 26, 2021
The use of molnupiravir in COVID-19 cases aims to reduce the pressure on hospitals, in turn reducing the risk of patients developing more severe symptoms of the virus.
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EMA issues advice on use of Lagevrio for the treatment of COVID-19
EuropeanPharmaceuticalReview
November 25, 2021
The European Medicines Agency (EMA)’s human medicine committee, the Committee for Medicinal Products for Human Use (CHMP), has issued advice on the use of Lagevrio...
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EMA supports molnupiravir prior to formal authorisation
PharmaTimes
November 23, 2021
The European Medicines Agency (EMA) has issued emergency use advice (EUA) supporting a decision by national authorities for the possible early use of Merck's molnupiravir, the oral antiviral drug for the treatment of patients with COVID-19.
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EMA CHMP issues advice on usage of Merck-Ridgeback’s Covid-19 medicine
Pharmaceutical-Technology
November 23, 2021
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued advice on the usage of Merck Sharp & Dohme and Ridgeback Biotherapeutics’ Lagevrio (molnupiravir/ MK 4482) to treat Covid-19.
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EMA Begins Evaluation of Novavax' COVID-19 Vaccine
ContractPharma
November 18, 2021
Novavax, Inc. announced that European Medicines Agency (EMA) has begun its evaluation of an application for conditional marketing authorization (CMA) for its COVID-19 vaccine...
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EMA stops rolling review of Lilly’s antibodies for Covid-19
Pharmaceutical-Technology
November 04, 2021
The European Medicines Agency (EMA) has ended the rolling review of the marketing authorisation application for Eli Lilly Netherlands’ antibodies, bamlanivimab and etesevimab, to treat Covid-19.
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WuXi Biologics Biosafety Testing Facility Received Second EMA GMP Certificate
prnasia
August 03, 2021
WuXi Biologics, a global company with leading open-access biologics technology platforms, announced that only 13 months after receiving its first GMP certificate, it has once again received a European Medicines Agency (EMA) GMP certificate for the ...
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EMA’s human medicine committee (CHMP) meeting highlights, July 2021
europeanpharmaceuticalreview
July 27, 2021
The Committee for Medicinal Products for Human Use (CHMP) recommended two medicines for approval and provided a negative opinion on Nouryant.
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CHMP recommends expanded use for Alexion’s PNH therapy Ultomiris
pharmatimes
July 27, 2021
AstraZeneca’s (AZ) Ultomiris has received a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to expand its use to include children and adults with ...