Centocor’s ustekinumab delayed
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA pushes Centocor's ustekinumab PDUFA date to December, granting the agency more time to review BLA amendments, the firm announces Aug. 8. Ustekinumab was unanimously recommended by an FDA advisory committee in June for approval for moderate to severe psoriasis, but the panel asked the J&J unit for long-term studies to evaluate cancer risk. The drug, which is aiming for a dosing advantage with a four injections per year regimen, was originally slated for an agency decision in September (1Pharmaceutical Approvals Monthly July 2008, p. 3). According to Centocor, FDA is not seeking additional clinical trials for ustekinumab
You may also be interested in...
For NME Approvals, 2008 Looks A Lot Like 2007 At Mid-Year; Will Changes At FDA Turn The Tide?
So far, the approval trends for new molecular entities and novel biologics in the first half of 2008 suggest that this year’s final tally may look very similar to last year’s record-low approval total.
E.l.f. Facing Off Against Beauty Giants: Third Among Mass Market Brands As Sales Jump 78%
E.l.f. cosmetics climbed to No. 3 brand in US mass market cosmetics, up two slots from a year ago as it surpassed Revlon and CoverGirl. In its recent sales and earnings presentation, it announced sales in its fiscal 2023 fourth quarter jumped 78%.
Quick Listen: Scrip's Five Must-Know Things
In this week's podcast edition of Five Must-Know Things: novel BMS drug shows promise in IPF; Novo’s oral semaglutide compares well with injectable in weight loss; Teva looks to innovative brands to return to growth; US setback for Intercept’s NASH drug; and India’s improving environment for clinical trials.