European Medicines Agency

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

The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the marketing authorisation in the EU for Janssen-Cilag International’s guselkumab — a treatment for moderate to severe plaque psoriasis. more

18 Sep 2017 13:41 News

Swiss specialty pharmaceutical company, Santhera Pharmaceuticals, has received a negative opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for its revised marketing authorisation application for Raxone in DMD more

15 Sep 2017 12:07 News

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) will begin sharing non-public and commercially confidential information, as reported by the Regulatory Affairs Professionals Society (RAPS). more

25 Aug 2017 11:24 News

Global research and development-based pharmaceutical company, Eisai, has submitted a marketing authorization application to the European Medicines Agency (EMA) for its first-line hepatocellular carcinoma treatment, lenvatinib. more

27 Jul 2017 11:55 News

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for a once-daily darunavir-based single tablet regimen (STR) for the treatment of HIV. more

26 Jul 2017 14:43 News

Sanofi and Regeneron Pharmaceuticals have announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for marketing authorization of Dupixent (dupilumab). more

24 Jul 2017 10:00 News

With the implementation of the new European Union In Vitro Diagnostic Regulation (EU IVDR) commencing, questions have been raised on companion diagnostic (CDx) development, which were assessed at a recent meeting held by ARC Regulatory. more

14 Jul 2017 11:26 News