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European Medicines Agency

Manufacturers of heartburn medications in both the US and Europe are being told by regulatory agencies to test for potential cancer-causing impurities. Read more

News

The European Medicines Agency (EMA), together with the Heads of Medicines Agencies (HMA) guide marketing authorisation holders (MAH) on how to address medicinal product shortages. Read more

News

A major campaign has been launched in Brussels to help attract UK-based pharma and life science business to the Belgian capital following Brexit. Read more

News

The government is being asked to provide clarity on whether it can guarantee access to medicines and medical products in the event of a ‘no deal’ Brexit. Read more

News

With the end result of Brexit fast approaching, labelling supplier Kallik looks at the implications Brexit could place on labelling and compliance in the pharmaceutical sector. Read more

Opinion

Innovative cancer drugs are taking longer to get to patients due to delays in clinical trials and regulatory red tape, new data shows. Read more

News

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… Read 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. Read 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. Read 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). Read 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. Read 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) Read 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 Read 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. Read 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. Read 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… Read 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) Read 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). Read 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. Read 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 Read more

Analysis