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Highlights of the EMA’s human medicine committee meeting, April 2021
europeanpharmaceuticalreview
April 27, 2021
The Committee for Medicinal Products for Human Use (CHMP) recommended eight drugs for approval and nine indication extensions.
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Roche’s Enspryng leads latest CHMP recommendations
pharmatimes
April 27, 2021
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended eight new medicines for approval in its April meeting.
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Bristol Myers Squibb Receives Positive CHMP Opinion for Onureg® for Adults with Acute Myeloid Leukemia in First Remission
americanpharmaceuticalreview
April 26, 2021
Bristol Myers Squibb has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Onureg® (azacitidine tablets; CC-486) as a maintenance therapy in adult patients with ...
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Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna
worldpharmanews
March 31, 2021
EMA's human medicines committee (CHMP) has adopted several important recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU.
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Five new meds recommended in March CHMP decisions
pharmatimes
March 30, 2021
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended five new medicines for approval at its March meeting, as well as six recommendations of current indications.
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Saxenda® recommended for approval by European Medicines Agency committee for the treatment of obesity in adolescents aged 12-17 years
prnasia
March 29, 2021
Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has recommended that the use of Saxenda® is expanded for the treatment of obesity in adolescents aged 12–17 years.
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J&J gets positive CHMP opinion for single-shot COVID-19 vaccine candidate
expresspharma
March 12, 2021
If granted conditional marketing authorisation by the EC, the J&J single-shot COVID-19 vaccine will be available in the EU.
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EMA Issues Advice on bamlanivimab Alone, Administered Together with etesevimab for COVID-19 in EU
americanpharmaceuticalreview
March 10, 2021
Eli Lilly and Company announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for bamlanivimab alone and bamlanivimab administered together with etesevimab.
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EMA concludes review of Lilly’s COVID-19 antibody therapies
europeanpharmaceuticalreview
March 09, 2021
The human medicines committee decided that there was significant evidence to endorse the use of a combination of bamlanivimab and etesevimab in outpatients at high risk of severe COVID-19.
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CHMP issues positive opinion for Lilly’s COVID-19 antibodies
pharmatimes
March 08, 2021
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the use of Eli Lilly’s COVID-19 antibodies bamlanivimab and etesevimab.