Product News

Share this article:

GlaxoSmithKline submitted follow-up data and information to the FDA for Cervarix, the company's cervical cancer drug. Cervarix would become the second HPV vaccine on the market in the US, competing with Merck's Gardasil. GSK submitted data from its phase 3 trials, HPV-008. FDA had already reviewed interim data from the same trial, and requested more information. GSK expects FDA's review of Cervarix's biologics license application to take six months.

 

Novartis announced FDA's approval of Afinitor, a kidney cancer drug. Afinitor is indicated for patients with advanced renal cell carcinoma, after failure of treatment with sunitinib or sorafenib.

Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Business Briefs

Email Newsletters

More in Business Briefs

Apple selfies spur diabetes donations

Jazz apples has launched a Crunch to Contribute campaign to raise money for one of two diabetes associations.

Baxter seeks Cambridge, Mass. HQ

Illinois may be tempted to offer tax incentives for the firm to stay put.

FDA wants Alexion to clean up

FDA inspectors have cited the manufacturer of the rare-disease drug Soliris (eculizumab) for poor manufacturing practices.