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European Medicines Agency

In preparations for Brexit, the EMA has redistributed the UK’s product portfolio to other EU members and is not allocating any centralised marketing authorisation applications to the MHRA. We take a closer look… more

Opinion

An ongoing review of valsartan medicines by the European Medicines Agency (EMA), has led to the detection of low level of nitrosodiumethylamine (NDMA) in medicines produced by another company, Zhejiang Tianyu. more

News

As Brexit edges nearer, the European Medicines Agency has revealed further temporary scale backs and suspension of activities as a result of higher than expected staff losses resulting from its move from London to Amsterdam. more

News

A gene therapy for the treatment of adolescent and adult patients with transfusion-dependent β-Thalassemia (TDT) is granted an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). more

News

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended broadening the existing marketing authorisation for Janssen’s Darzalex (daratumumab) as a frontline treatment. more

News

Last week, the UK government saw heated debates and closely contested votes on the post-Brexit strategy, including a favourable outcome for the future relationship of the UK and the European Medicines Agency (EMA) more

News

Akcea Therapeutics and Ionis Pharmaceuticals have announced that Tegsedi (inotersen) has received European marketing authorisation approval for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hATTR more

News

Data and analytics company, GlobalData, has revealed that recent survey findings from the European Medicines Agency (EMA) into Brexit preparedness of the pharma industry support its own conclusions on the matter. more

Analysis

Some medicines containing valsartan used for the treatment of high blood pressure and heart conditions are being recalled across Europe to be reviewed by the European Medicines Agency (EMA) to determine the extent of ingredient impurity. more

News

Now we have just passed the six-month marker (1 July) until the European Medicines Agency (EMA) moves from its current location in London to Amsterdam, as a result of Brexit, we gauge industry response to this change… more

Opinion

Cablivi (caplacizumab) has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the treatment of a rare blood-clotting disorder, acquired thrombotic thrombocytopenic purpura (aTTP) more

News

‘Doing nothing is not an option’ is the overriding message from pharmaceutical experts who attended the recent Pharmaceutical Industry Network Group (PING) seminar, held in conjunction with Ethical Medicines Industry Group (EMIG). more

News

Pooja Phogat, regulation and compliance expert at Kinapse, advises on the best approaches to balancing the risk of patient re-identification with the need for greater data utility. more

Opinion

The ability of animal studies to predict human safety has been evaluated by global information analytics business, Elsevier, through big data analysis of adverse events reported to the US FDA and EMA more

Analysis

Here we count down the top five tweets from @EPM_magazine that have gained the most impressions this week, taken from Twitter analytics. more

News

The European Medicines Agency (EMA) has approved AstraZeneca and Merck’s Lynparza (olaparib) tablets as maintenance therapy for the treatment of platinum-sensitive relapsed ovarian cancer, regardless of BRCA status. more

News

Independent consulting group, NDA, has announced its findings from its fifth annual comparison of drug approvals in Europe and the US in preparation for this year’s DIA Europe in Basel, Switzerland. more

Analysis

TrakCel, software developer for gene therapy supply chain tracking and orchestration, has announced it will be organisation that is responsible for tracking and documentation of cell and gene therapy products for the Northern Alliance more

News

With recent plans announced by the UK’s prime minister to remain part of the EMA, which would be favourable for many in the pharma industry, I will look at these developments as well as how they will impact industry and the reactions from leaders more

Opinion

The marketing authorisation application (MAA) for cemiplimab as a potential treatment for advanced cutaneous squamous cell carcinoma (CSCC) has been accepted for review by the European Medicines Agency (EMA). more

News