GSK timeframe for Cervarix launch uncertain
This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryGlaxoSmithKline intends to respond to FDA's "complete response" letter for its human papilloma virus vaccine Cervarix in the second quarter, CEO JP Garnier says during a year-end earnings call Feb. 7. But, he added, "I don't know when the timing of the launch is going to be because frankly the FDA is not going to give us an answer for quite a while, and they would want to go in front of the advisory committee first." GSK continues to prepare to compete with Merck's HPV vaccine Gardasil; GSK is conducting a head-to-head trial of the vaccines and expects to release data later this year...
You may also be interested in...
Hours before the US FDA confirmed the first drug shortage due to active pharmaceutical ingredient constraints because of the coronavirus situation in China, generics industry leader Mylan came under pressure about the potential impact on its business.
Government advisory committee gives initial nod to what will become Japan’s most expensive single drug, but reimbursement pricing could come in for close scrutiny.
Laparoscopic power morcellation to remove uterine fibroids should only be performed with the use of a compatible containment system, and only on women younger than 50, the US FDA said in a newly published safety communication and draft guidance document. See what the president of the gynecologic trade group AAGL, Jubilee Brown, said about it here.