GSK faces new delays (NYSE:GSK)
GSK, one of the top pharmaceutical companies, is facing new delays over the approval of their vaccine Cervarix that is aimed for the treatment of cervical cancers. GSK said that the reason for delay is because the FDA failed to complete their review on Cervarix by the anticipated deadline. However, soon GSK was dragged into deeper problems when a 14-year old school girl in UK died hours after receiving the Cervarix vaccine.
However, the FDA has clearly denied that the cause for the delay was not because of the death. Hours later, NHS declared that the post-mortem was done and they are assured that the death was not due to the vaccine. GSK says that they are confident about Cervarix and will submit their reports to FDA and are expecting that the Food and Drug Administration panel will soon review their cervical cancer vaccine.
The news about the death of a the UK schoolgirl spread like a wild fire and it had effected the shares of GSK. However, GSK had a sigh of relief when NHS claimed that the death was due to some underlying health problem and not because of the Cervarix vaccine injected hours ago before she died.
Due to so many cases of suspected reactions to Cervarix in the United Kingdom, GSK is having trouble in the US from the outset. In 2007, many regulators were not ready to approve the vaccine until GSK stepped forward and provided more information about the vaccine. Currently, the Food and Drug Administration panel has stated that they might give a positive response to GSK’s cervical cancer vaccine, but they are busy implementing new post-marketing requirements for certain products.
Tags: cervarix, GSK
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