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Janssen submits MAA to EMA for esketamine nasal spray pharmaceutical-technology
October 12, 2018
Johnson & Johnson’s Janssen Pharmaceutical Companies has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for its esketamine nasal spray.
Novartis Announces FDA, EMA Filing Acceptance of Siponimod americanpharmaceuticalreview
October 12, 2018
Novartis announced that both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted the company's New Drug Application (NDA) and Marketing Authorization Application (MAA) respectively, for investigational oral, once-da
EMA Brexit preparedness business continuity plan enters third phase expressbpd
October 11, 2018
The European Medicines Agency’s (EMA) Brexit preparedness BCP entered into its third phase recently as announced at the beginning of August 2018.
EMA feeling better about drug supply interruptions from Brexit fiercepharma
September 27, 2018
The European Medicines Agency says concerns over drug supply shortages stemming from Brexit have eased, but not all drugmakers feel the same.
Novartis moving 400 employees to Amsterdam fiercepharma
September 20, 2018
After more than 50 years in Arnhem, the Netherlands, Novartis has decided to move its Dutch operations to Amsterdam, the new home of the European Medicines Agency (EMA).
Protecting the links between the UK and the EMA cphi-online
August 15, 2018
Now less than a year away from when the UK officially leaves the EU, the main goal remains the same - maintaining access to new drugs for patient health.
EMA issues positive opinion to Janssen’s INVOKANA and VOKANAMET biospectrumasia
August 07, 2018
The positive opinion will now be reviewed by the European Commission, which has the authority to grant approval of the updated label.
EMA grants PRIME status for Roche Huntington's drug pharmatimes
August 06, 2018
The EMA has granted PRIME designation to Roche's RG6042 for treatment of Huntington’s disease.
EMA to cut activities as it forecasts loss of 30% of staff pharmafile
August 03, 2018
The European Medicines Agency is set to enact temporary cuts in activities as it prepares for significant disruption in the wake of Brexit.
Brexit forces EMA to suspend tasks as job loss forecast jumps August 03, 2018
The EMA is suffering heavier than expected job losses as a result of its relocation to the Netherlands, forcing it to scale back and suspend more of its activities. International collaborations......

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