European Medicines Agency

Data and analytics company, GlobalData, has revealed 2017 was a record-breaking year for the number of approvals of biosimilars. more

14 Mar 2018 12:32 Analysis

Biogen and AbbVie have announced the voluntary global withdrawal of Zinbryta (daclizumab) — a treatment for relapsing multiple sclerosis (MS) — in the best interests of patient safety. more

7 Mar 2018 12:42 News

The European Medicines Agency (EMA) has recommended that women taking Esmya (Ulipristal acetate) for the treatment of uterine fibroids should undergo regular liver function tests while it performs a review of the therapeutic safety. more

22 Feb 2018 12:43 News

In this article, NSF International goes into detail about what the potential ramifications of Brexit may be on the regulatory landscape in pharma. more

7 Feb 2018 12:00 Opinion

Here, Vikash Patel, senior regulatory specialist for ELC Group, gives us an update on the regulatory developments impacting the pharma industry as a result of Brexit. more

7 Feb 2018 10:00 Opinion

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

2 Feb 2018 15:00 News

Sanofi has requested a review by the European Medicines Agency (EMA) of its treatment for sleeping sickness, fexinidazole, which it is developing in collaboration with the Drugs for Neglected Disease initiative (DNDi). more

31 Jan 2018 12:35 News

The European Medicines Agency (EMA) has accepted the conditional marketing authorisation application for avacopan in the treatment of patients with anti-neutrophil cytoplasmic antibody associated vasculitis. more

4 Jan 2018 12:00 News

One of the potential pitfalls when preparing a product launch is planning for GMP inspections. An upside of recent events, is worksharing, leading towards a more globalised market. In this article Vikash Patel, ELC Group tells us more... more

21 Dec 2017 09:00 Opinion

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

24 Nov 2017 15:17 News

We have now had a few days to digest the outcome of the relocation vote that took place on Monday 20 November, revealing that the European Medicines Agency (EMA) will be relocated to Amsterdam. But, what should we expect from this relocation? more

24 Nov 2017 14:57 News

Developer of placenta-based cell therapy products, Pluristem, has been granted a key US patent by the US Patent and Trademark Office (USPTO) relating to the use of Mesenchymal Stem Cells (MSCs) for muscle regeneration. more

24 Nov 2017 11:58 News

As the final preparations are underway for the launch of the new EudraVigilance system by the EMA, SSS International Clinical Research has revealed the steps it has taken to ensure it can effectively support pharma companies more

21 Nov 2017 12:34 Analysis

The results of the vote for the relocation of the European Medicines Agency (EMA) have been revealed, its new location will be Amsterdam. Here are some key industry responses… more

20 Nov 2017 18:51 News

Today (Monday 20 November) is the day that will see the first vote on the new location of the European Medicines Agency (EMA) be made by European Union (EU) ministers. more

20 Nov 2017 14:45 News

Harriet Lewis, ABPI's Medicines Optimisation Lead, discusses the future of biosimilars in the UK asking the pertinent question: will they revolutionise healthcare? more

23 Oct 2017 10:00 Opinion

A retrospective cohort study has found no conclusive evidence that most oncology treatments approved for use by the EMA offered survival or quality of life benefits to patients, giving rise to calls for an increase in the evidence bar. more

6 Oct 2017 12:34 News

The European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) of a biosimilar version of Neulasta (pegfilgrastim) to treat chemotherapy-induced neutropenia from Cinfa Biotech. more

6 Oct 2017 12:28 News

The importance of the upcoming decision of the relocation of the EMA has been highlighted through the outcome of the recent survey into staff retention, which has demonstrated that certain locations may leave the agency severely lacking in staff. more

2 Oct 2017 12:35 News

Antiepileptic drugs and the potentially harmful effects on unborn children has hit the headlines as a survey reveals many women have not received the new safety warnings about the dangers of taking it during pregnancy. more

22 Sep 2017 12:22 News