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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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European Medicines Agency (EMA)
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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.
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Spotlight: a dispersible tablet formulation to treat HIV in children
A novel formulation for dolutegravir has been developed to improve HIV treatment options for children. Dr Kimberly Smith from ViiV Healthcare discusses the benefits of this new dispersible tablet.
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Recommendations made by EMA to unlock big data potential
Ten priority actions have been recommended for the European medicines regulatory network to evolve its approach to data use.
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Regulatory expansion submitted for SPRAVATO® (esketamine) nasal spray
Janssen have applied to the EMA to extend the use of esketamine to a short-term treatment for the rapid reduction of depressive symptoms in adults with MDD who are suicidal with the intent.
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Summarising 2019: a year of firsts for the EMA
The EMA was a proactive force in 2019, granting marketing authorisation for a range of drugs. This article highlights some of the most important advancements made by the agency last year.
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HIV treatment Dovato (dolutegravir/lamivudine) approved in Japan
The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted marketing approval for Dovato, a treatment for HIV-1 infection.
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EMA announces launch of collaborative pilot scheme to inspect manufacturers
The EMA will collaborate with other medicine regulatory bodies globally in a pilot programme to inspect sterile medicine manufacturers.
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Lumasiran drug achieves primary and secondary endpoints in Phase III study
Lumasiran, an investigational drug to treat primary hyperoxaluria type 1, has met its endpoints in clinical trials.
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EPR’s news round-up 2019: the stories that defined the year
This article highlights the 10 most popular news stories published by European Pharmaceutical Review in 2019.
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EMA releases findings from pharmacovigilance report
A new pharmacovigilance document from the European Medicines Agency shows that the medicine safety system in the EU is effective.
