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EMA offers free advice to COVID-19 vaccine and therapeutic developers europeanpharmaceuticalreview
March 17, 2020
The European Medicines Agency (EMA) announced it will provide free advice to those working on COVID-19 therapeutics and vaccines in the hopes of accelerating approval of a treatment.
EMA begins safety review of ifosfamide cancer medicines europeanpharmaceuticalreview
March 17, 2020
The EMA has announced the results of its pharmacovigilance meeting for March, saying that it has started a review of medicines containing ifosfamide due to a higher risk of encephalopathy.
EMA announces measures to manage drug shortages as result of COVID-19 europeanpharmaceuticalreview
March 16, 2020
An EU Executive Steering Group will discuss how to address the impact of medicine shortages caused due to COVID-19, says the EMA.
EU addresses potential impact of COVID-19 on medicines supply expresspharma
March 12, 2020
The mandate is to provide strategic leadership for urgent and coordinated action within the EU in case a crisis caused by major events.
Trelegy Ellipta filing accepted by EMA for asthma pharmatimes
March 06, 2020
The European Medicines Agency (EMA) has accepted GlaxoSmithKline’s regulatory submission seeking an additional indication for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for the treatment of asthma.
CHMP recommends just two new meds in Feb meeting pharmatimes
March 06, 2020
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended just two new medicines for approval at its February 2020 meeting, as well as three extensions of pre-existing therapies.
EMA PRIME status granted to Janssen’s inherited retinal disease gene therapy pharmatimes
March 06, 2020
Janssen has announced that the European Medicines Agency (EMA) has granted both PRIME (PRIority MEdicines) and Advanced Therapy Medicinal Product (ATMP) designations to its adeno-associated virus (AAV)-RPGR gene therapy product ...
EMA announces update on nitrosamine impurities in medicines europeanpharmaceuticalreview
March 05, 2020
The EMA has released an update on nitrosamines in drugs, saying that work is continuing to prevent and manage these impurities.
FDA and EMA accept licence applications for multiple sclerosis treatment europeanpharmaceuticalreview
March 04, 2020
The FDA and EMA have accepted licence applications for ofatumumab, a novel B-cell therapy for patients with relapsing forms of multiple sclerosis (RMS).
Orphan Drug Designations are declining, says market analysis europeanpharmaceuticalreview
March 04, 2020
A report has suggested that number of Orphan Drug Designations in both the US and Europe is declining, possibly due to prices and political changes.

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