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EMA begins safety review of ifosfamide cancer medicines
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.
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European Medicines Agency (EMA)
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EMA offers free advice to COVID-19 vaccine and therapeutic developers
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.
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EC grants Orphan Drug Designation to FLT190, a Fabry Disease treatment
FLT190 gene therapy has been granted Orphan Drug Designation based on preliminary trial data and the positive opinion of an EMA committee.
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EMA announces measures to manage drug shortages as result of COVID-19
An EU Executive Steering Group will discuss how to address the impact of medicine shortages caused due to COVID-19, says the EMA.
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EC grants marketing authorisation to Givlaari® (givosiran) for acute hepatic porphyria
The developers of givosiran announced the European Commission (EC) has granted the drug marketing authorisation based on results of the Phase III ENVISION trial.
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EMA announces update on nitrosamine impurities in medicines
The EMA has released an update on nitrosamines in drugs, saying that work is continuing to prevent and manage these impurities.
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Orphan Drug Designations are declining, says market analysis
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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EMA releases results from February meeting, recommending two medicines
The EMA has recommended granting marketing authorisation to two medicines and extending the indications for three more following its latest meeting.
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FDA and EMA accept licence applications for multiple sclerosis treatment
The FDA and EMA have accepted licence applications for ofatumumab, a novel B-cell therapy for patients with relapsing forms of multiple sclerosis (RMS).
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EMA announces restrictions to cyproterone use due to meningioma risk
After a review of cyproterone, the EMA has recommended that the drug only be prescribed once other treatment options have failed, due to an increased meningioma risk.
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The importance of labelling compliance for pharma
Bart Vansteenkiste explains why it is important to validate pharmaceutical labelling compliance to ensure good manufacturing practice.
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MHRA suspends license for Picato over concerns of skin malignancy risk
The marketing license for ingenol mebutate gel (Picato) has been suspended by the MHRA due to studies showing an increased risk of skin malignancies from the drug.
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Resolving and mitigating medicine shortages in the EU
Drug shortages can greatly impact patients and the pharmaceutical industry. Adrian van den Hoven, Director General of Medicines for Europe, explains how to prevent and reduce the effects of medicinal scarcities in the EU.
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Coronavirus: EMA announces support for treatment research
The EMA has released a statement on its efforts to support the development of a treatment for the novel coronavirus (2019-nCoV).
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Medical Devices Regulation: delays and confusion
The EU Medical Devices Regulation will apply in May 2020. Maurits Lugard and Josefine Sommer of Sidley Austin LLP examine what the changes mean for the medtech industry.
