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EMA human medicines committee meeting highlights, June 2021 europeanpharmaceuticalreview
June 28, 2021
Drugs recommended for approval by the European Medicines Agency’s human medicines committee included a gene therapy and two generics, among five others.
Moderna’s new Covid-19 vaccine production facility gets EMA approval pharmaceutical-technology
June 15, 2021
Moderna has received the European Medicines Agency’s (EMA) committee for human medicines (CHMP) approval for a new production facility in Monts, France, to manufacture its Covid-19 vaccine.
EMA to assess whether COVID-19 Vaccine Moderna can be used in adolescents europeanpharmaceuticalreview
June 10, 2021
The European Medicines Agency (EMA) has begun evaluating whether to extend the use of the COVID-19 Vaccine Moderna to include adolescents aged 12 to 17.
EMA recommends first COVID-19 vaccine for children aged 12 to 15 europeanpharmaceuticalreview
June 03, 2021
The EMA is recommending that the Comirnaty® COVID-19 vaccine’s indication be extended to include children aged 12 to 15 years.
CHMP puts eight new medicines forward for EU approval pharmatimes
May 25, 2021
An investigational pneumococcal conjugate vaccine (PCV) candidate, developed by MSD, has achieved positive topline results in a Phase III paediatric study.
Merck Receives Positive EU CHMP Opinion for KEYTRUDA® in Combination With Chemotherapy as First-Line Treatment for Patients With Esophageal Cancer or GEJ Adenocarcinoma americanpharmaceuticalreview
May 25, 2021
Merck announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum- and ...
Positive CHMP opinion for self-administered Crysvita pharmatimes
May 11, 2021
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Kyowa Kirin’s Crysvita for a new self-administration option to treat the rare metabolic bone disease X-linked hypophosphataemia (XLH).
Paediatric and adolescent COVID-19 vaccines update europeanpharmaceuticalreview
May 07, 2021
The EMA is evaluating whether to lower the age at which Comirnaty can be administered and Novavax has begun testing its COVID-19 vaccine in paediatric patients.
Tagrisso moves closer towards EU approval for early-stage lung cancer pharmatimes
April 29, 2021
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended AstraZeneca’s (AZ) Tagrisso for approval in the EU for the treatment of early-stage lung cancer patients.
CHMP suggests AstraZeneca and Merck’s selumetinib for paediatric patients pharmaceutical-technology
April 28, 2021
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended AstraZeneca and Merck’s (MSD) selumetinib for conditional marketing authorisation in the EU for treating children aged three years and ...

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