The European Medicines Agency has given GlaxoSmithKline a thumb's up for Daronrix, its pandemic flu vaccine. The European Commission will now take up the issue. Glaxo's victory at the EMEA followed an extraordinarily swift development process, with clinical trials beginning in April. The drug developer filed what's called a mock-up dossier on the vaccine, asking for approval against one strain of the H5N1 virus. In the event of a potential pandemic, Glaxo would adapt the vaccine to work against the pandemic strain without having to go back to regulators to ask for approval again.
- see this GSK press release
- read the report on the vaccine from MarketWatch