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EMA CHMP advises use of Pfizer’s Covid-19 oral antiviral Paxlovid
Pharmaceutical-Technology
December 20, 2021
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the usage of Pfizer’s oral antiviral, Paxlovid (nirmatrelvir plus ritonavir), to treat adult Covid-19 patients.
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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.