EMA

European Medicines Agency recommends authorisation of additional vaccine for influenza pandemic (H1N1) 2009

The European Medicines Agency has recommended to the European Commission that an additional vaccine against influenza A(H1N1) ('swine flu'), Celvapan from Baxter, be granted a marketing authorisation. Adoption of an authorisation decision by the European Commission is expected shortly. This recommendation follows the authorisation of Focetria, from Novartis, and Pandemrix, from GlaxoSmithKline, by the European Commission on 29 September 2009.

European Medicines Agency recommends authorisation of two vaccines for influenza pandemic (H1N1) 2009

The European Medicines Agency has recommended to the European Commission that two vaccines against influenza A(H1N1) ('swine flu') be granted a marketing authorisation. Vaccines are one of the most important tools in the management of an influenza pandemic, helping to reduce illness and deaths by building up immune protection against the pandemic flu virus.

The bacterial challenge - time to react

There is a need for more development of antibiotics that are effective against multidrug-resistant bacteria. That is the conclusion of a new report prepared jointly by the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMEA) with contributions from the international network Action on Antibiotic Resistance (ReAct).

EMEA and FDA launch Good Clinical Practice Initiative

The European Medicines Agency and the FDA have agreed to launch a joint initiative to collaborate on international Good Clinical Practice (GCP) inspection activities. This initiative comes under the scope of the confidentiality arrangements between the European Commission, the European Medicines Agency and the US FDA. The objectives of the initiative include the sharing of information on inspection planning, policy and outcomes and the conduct of collaborative inspections.

European Medicines Agency review of pandemic vaccines underway

The European Medicines Agency has started to receive data on H1N1 pandemic vaccines and the review began in July, with the commitment from the Committee for Medicinal Products for Human Use, to fast-track the review of data as vaccine manufacturers make them available. Given the public health threat posed by the current pandemic, the Agency's goal is to ensure data submitted to support marketing authorisations for vaccines are reviewed as early as possible, before the beginning of the Northern hemisphere flu season, expected in September.

European Medicines Agency update on safety of insulin glargine

Following review of all available information on a possible relationship between insulin analogues, in particular insulin glargine, and the risk of cancer, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the available data does not provide a cause for concern and that changes to the prescribing advice are therefore not necessary.

European Medicines Agency update on safety of insulin glargine

The European Medicines Agency (EMEA) is looking into four recently published registry studies investigating a possible relationship between insulin analogues, in particular insulin glargine, and the risk of cancer. The studies were published on the Diabetologia website on 26 June 2009.

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