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GSK says flu vaccine approval is coming

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GlaxoSmithKline issued assurances today that its swine flu shot will be approved by federal regulators "as soon as possible."

On Tuesday the Food and Drug Administration approved vaccines made by four of the five companies expected to manufacture swine flu vaccines. London-based GSK, which has its U.S. headquarters in Research Triangle Park, is the fifth company whose vaccine wasn't approved.

"It's a timing thing," Claire Brough, a GSK spokeswoman, told Bloomberg News today.

Health and Human Services Secretary Kathleen Sibelius said Tuesday that the fifth manufactuer's vaccine was expected to be approved soon. She didn't identify GSK by name.

Glaxo reported last month that it has a total of $250 million in orders for the vaccine from the federal government.

The manufacturers whose vaccine was approved are: CSL Ltd. of Australia, Switzerland's Novartis Vaccines, Sanofi Pasteur of France and Maryland-based MedImmune.

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right...

... of course you could always develop your own vaccine.

The FDA best not rush

The FDA best not rush vaccines into production like they let other companies rush their drugs into the marketplace.

On another note-- I can image what astronomical price GSK will demand for this vaccine!?

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About the blogger

David Ranii has been a business reporter at The News & Observer since 1993. Over the years he has covered information technology, banking, insurance, the pharmaceutical and biotechnology industries, media businesses and real estate. Contact him at 919-829-4877 or e-mail him.
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