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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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European Medicines Agency (EMA)
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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.
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Statement from UK government on EU trade, including pharma industry
A written statement from the UK government has highlighted the importance of trade co-operation with the EU, including for pharmaceuticals.
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CHMP recommends fifteen therapeutics at latest meeting
The EMA’s human medicines committee (CHMP) recommended fifteen medicines for various approvals at its January 2020 meeting; with ten drugs receiving marketing authorisation recommendations and five receiving positive opinions for specific treatments.
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EMA announces next steps for UK pharma industry after Brexit
The EMA has released a statement, outlining the future for the UK's pharmaceutical industry in the transition period following Brexit and thereafter.
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EC approves KTE-X19 for treatment of mantle cell lymphoma
KTE-X19, an investigational CAR T-cell therapy, has been granted marketing authorisation by the European Commission.
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Key principles for electronic product information implementation in EU released
The EC, EMA and HMA have published key principles on the various benefits of sharing medicinal product information electronically and how to implement this system.
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EC approves ustekinumab to treat plaque psoriasis in patients age six to 11
The European Commission has granted marketing authorisation to Stelara (ustekinumab) to treat patients aged six to 11 with moderate to severe plaque psoriasis.
