PDUFA

PDUFA date set for idelalisib in lymphoma

The FDA will review the drug for refractory indolent non-Hodgkin's lymphoma.

FDA pushes review date for Biogen blood drug

The agency extended the review time for Biogen's Alprolix by three months.

Amarin's hopes for Vacepa dim

The FDA told the drugmaker in a letter before the December PDUFA date that evidence does not support an expanded indication.

Business briefs: GlaxoSmithKline and Spectrum

GSK sees a regulatory setback on its once-weekly GLP-1 med, and Spectrum Pharma gets hit with an untitled letter from OPDP on a sales aid for Zevalin.

Sequester cuts could snarl approvals for years

Sequester cuts could snarl approvals for years

By

With sequester cuts taking effect and no sign of a deal to end them in sight, FDA stands to lose 5% of its 2013 budget—though coming five months into the Federal fiscal year, it will feel more like 9%—and while the agency has said it has no plans at present for layoffs, it's certain the approvals process will slow as the agency absorbs the loss.

The Women's Health landscape is ripe with opportunity for pharma marketers. This seven-page eBook offers product managers a guide to capitalizing on the trends, growth areas and unmet needs. Includes alternative channels to engage OB/GYNs and oncologists, and plenty of tips. Click here to access it.

Email Newsletters