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European Medicines Agency

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

Veltassa (patiromer), developed by Relypsa, has received a recommendation for marketing approval from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the treatment of hyperkalaemia. more

19 May 2017 12:07 News

Lini Subin, director — regulatory affairs, ELC Group, highlights EMA’s regulatory tools and support pathways that are available during development. more

17 May 2017 10:00 Opinion

As the industry realigns itself to some major changes, EPM magazine also has a shake up. more

5 May 2017 14:46 Opinion

Kiadis Pharma, a clinical stage biopharmaceutical company, has submitted a marketing authorisation application (MAA) to the EMA for its lead product ATIR101 more

28 Apr 2017 16:20 News