European Medicines Agency

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

A data-focused clinical research organisation (CRO), Quanticate, has completed an investment initiative to upgrade its pharmacovigilance safety database and its in-house technology platform in preparation for an upcoming EU directive more

7 Jul 2017 11:17 News

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion, recommending that biosimilar Imraldi be granted marketing authorisation. more

27 Jun 2017 11:52 News

Merck has announced that the CHMP of the EMA has issued a positive opinion for approval of Cladribine tablets for the treatment of relapsing forms of multiple sclerosis (RMS) in patients with high disease activity. more

26 Jun 2017 11:09 News

Data from a randomised controlled trial, presented at the International Conference on Malignant Lymphoma (ICML) has shown Truxima (CT-P10) to be non-inferior to the reference product in terms of overall and complete response rates more

15 Jun 2017 12:10 News

Narasimharaju SN, senior manager — regulatory affairs and Mac Kella, senior regulatory affairs executive at ELC Group assess whether biosimilars are really interchangeable in the EU. more

15 Jun 2017 09:20 , Opinion 1 Comments

The UK’s separation from the EU could have implications for regulatory harmonisation, and increase administrative workloads at a time when responsible teams are already overstretched and experienced talent is hard to find. more

13 Jun 2017 16:51 Opinion

The European Medicines Agency (EMA) has accepted for regulatory review the marketing authorisation applications for biosimilars to AbbVie’s Humira (adalimumab) and Janssen’s Remicade (infliximab) from Sandoz more

6 Jun 2017 14:07 News

The European Medicines Agency (EMA) has approved Zebinix (eslicarbazepine acetate) for use as once-daily monotherapy to treat adults with newly-diagnosed partial-onset epilepsy. more

25 May 2017 11:52 News