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EMA committee recommends Moderna’s Covid-19 vaccine for adolescents pharmaceutical-technology
July 27, 2021
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the marketing authorisation of the Moderna Covid-19 vaccine, Spikevax, for adolescents aged 12 to 17 years.
EMA grants Orphan Drug Designation to Saroglitazar Mg for treating patients with PBC expresspharma
July 22, 2021
Zydus announced that the European Medicines Agency (EMA) has granted ‘Orphan Drug Designation’ (ODD) to Saroglitazar Mg for the treatment of patients with Primary Biliary Cholangitis (PBC).
Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, July 2021 europeanpharmaceuticalreview
July 14, 2021
The Pharmacovigilance Risk Assessment Committee (PRAC) provided safety warnings on COVID-19 vaccines, and found no evidence linking Zynteglo to blood cancer.
BioMarin resubmits haemophilia A gene therapy to the EMA pharmatimes
June 30, 2021
BioMarin has resubmitted a marketing authorisation application (MAA) for its haemophilia A gene therapy valoctocogene roxaparvovec to the European Medicines Agency (EMA), the company announced 28th.
Covishield approval to be considered on receiving marketing authorisation application: EMA expresspharma
June 30, 2021
The Covishield vaccine “does not currently have a marketing authorisation” in Europe and the matter would be considered when an application is received for it, the European Medicines Agency (EMA) said.
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.
Alterity Therapeutics Limited Received European Union Regulatory Guidance for ATH434 Phase 2 Clinical Trial prnasia
June 24, 2021
Alterity Therapeutics Limited has received guidance from the European Medicines Agency (EMA) regarding key aspects of the Company's Phase 2 clinical trial for investigational drug ATH434 in the treatment of Multiple System Atrophy (MSA).
Janssen COVID-19 Vaccine – one regulator blocks use, another promotes it europeanpharmaceuticalreview
June 16, 2021
EU recommends that batches of Janssen COVID-19 Vaccine not be released for use due to a cross contamination report, while the FDA authorises use of drug substance from the facility where the contamination occurred.
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.

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