GSK hit with Cervarix application delay

After hearing that the FDA is demanding more information on Cervarix before it can be approved, analysts are estimating that GlaxoSmithKline could face delays of up to two years in launching the therapy in the U.S. That's a significant blow for the UK drug maker, which had been hoping to go head-to-head against Merck's Gardasil [1] and replenish sales in the U.S.--which have been hit hard [2] by dwindling sales of Avandia [3]. Adding to the confusion and uncertainty, Glaxo declined to spell out exactly what the FDA is looking for. That could mean anything from a short delay of a few months to answer technical questions to a serious time lag as researchers harvest more data from ongoing clinical trials of the vaccine.

- see GSK's release [4] on the setback
- here's the report [5] on the delay from The Guardian

ALSO: Is Tykerb GSK's cancer breakthrough? Report [6]

Related Articles:
GSK shakes up R&D. Report [7]
It's Merck v. Glaxo in vaccine battle. Report [1]
GSK prepares to go head-to-head with Merck. Report [8]
Merck's Gardasil OK'd for pricey rollout. Report [9]