US Cervarix delay deals blow to GlaxoSmithKline
US regulators have delayed their decision on whether to approve GlaxoSmithKline's cervical cancer vaccine Cervarix.
The ruling from the powerful US Food and Drug Administration had been expected yesterday but instead the body announced it needed more time to consider the application.
The FDA's renewed caution came just a day after the death of 14-year- old Coventry girl Natalie Morton who had been vaccinated with Cervarix.
Bombshell: The FDA delay over GSK's vaccine is not thought to be linked to the death of a 14-year-old British girl
There was no indication that the latest set back to winning US approval for the product had anything to do with the tragedy in the UK.
A spokesman for the drugs firm said: 'They (the FDA) have not asked for any further information following what happened in Coventry and if they did we would obviously be willing to share with them any information they requested as we would with UK authorities and any other countries. Clearly the most important thing right now is to ascertain what happened
Read more: http://www.dailymail.co.uk/money/article-1217022/US-Cervarix-delay-deals-blow-GlaxoSmithKline.html#ixzz0SXN8dBUo
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