The European Medicines Agency has installed a new specialist committee which will review for the first time, applications from companies developing gene therapies, cell-based products and therapies that are engineered from human and/or animal tissue.
Ark Therapeutics Plc said that the European Medicines Agency has accepted its application for a marketing authorisation to launch a novel gene therapy to treat brain cancer. The application is one of the first in a new group of advanced therapies that are being regulated under European legislation that took effect on 30 December 2008. Ark announced the start of the regulatory review of its product, Cerepro, on 6 January 2009.
The European Medicines Agency (EMEA) has published a draft policy document in which it proposes to significantly increase the number of regulatory documents made available to the public once a decision on a medicine has been made.
The European Medicines Agency (EMEA) is recommending that six new medicines be approved for sale in Europe and that two others be given broader indications. This follows an analysis of the product data by the agency’s Committee for Medicinal Products for Human Use at a meeting from 15 to 18 December 2008. The European Commission will formally issue the marketing authorisations.
The European Commission did not cite any wrongdoing by specific companies in its preliminary report on 28 November 2008 into whether certain practices have stifled pharmaceutical innovation in Europe and/or prevented generic medicines from reaching the market in a timely fashion. However, enforcement action cannot be ruled out later, according to lawyers familiar with the investigation. This will only be known when the Commission issues its final report which is expected in late March or early April 2009.
The European Medicines Agency (EMEA) will acquire new responsibilities for making sure that drugs launched on the European market are safe under legislation initiated by the European Commission.
Austria’s Intercell AG said it plans to launch its new vaccine against Japanese encephalitis in Europe in early 2009 following receipt of a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.
The European Commission is proposing that pharmaceutical companies be allowed to provide prescription-drug information directly to consumers, provided this is not advertising.
A group of biotechnology company chief executives and investors has called on the UK government to contribute at least £500 million for investment in Britain’s biotech sector, which can no longer count on getting sufficient funding from private sources because of the worldwide banking crisis.
The European Medicines Agency (EMEA) will soon propose a revision of its policy for the handling of commercially confidential information so as to make more regulatory documents available to the public.