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GlaxoSmithKline submits first pandemic flu vaccine to EMEA
GlaxoSmithKline submits first pandemic flu vaccine to
EMEA
Date published: 09/01/2006
The
European Medicines Agency (EMEA) has said that it has received a
pre-development application for a pandemic flu vaccine. GlaxoSmithKline
Biologicals sent the EMEA a "core dossier" proposal for the vaccine, which
allows pharmaceutical firms to suggest a "mock-up" version of a drug before a
pandemic occurs ? resubmitting to incorporate the flu strain once it has been
identified.
The agency said that it had encouraged firms last year to
use the approach through incentives such as fee waivers for scientific advice
and dossier evaluation. Its scientific committee also promised to speed up
evaluation and marketing authorisations for pandemic flu vaccines.
Meanwhile, Turkey has reported cases of bird flu in five more people,
including one adult and two children found to have contracted the H5N1 bird flu
virus near to the Turkish capital of Ankara. But the
World Health Organisation
told Reuters that the new cases had not been confirmed by laboratory tests, and
that only four people have been found to have died from the disease so far in
the country. It is not thought that the virus has developed into the pandemic
form. Twenty-one patients have been taken into hospital in Istanbul. If tests
on the individuals return positive, then it would be the most western point the
disease has travelled.
© Adfero Ltd
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