Pfizer Pulls Lyrica sNDA As Adjunct For Anxiety Disorder
This article was originally published in The Pink Sheet Daily
Executive Summary
The FDA gave the pregabalin sNDA for generalized anxiety disorder monotherapy a "complete response" in December for insufficient data.
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In Brief
Further delay for Prevnar 13: FDA has not yet completed its review of Pfizer's Prevnar 13 vaccine for pneumococcal disease and therefore the review will continue beyond the Dec. 30 user fee deadline. It's not clear how much longer the review will take and there was no explanation for the delay, but there was no indication that additional information was sought, according to the drug maker's Dec. 30 statement. The vaccine is under priority review and FDA already used its one-time extension of the user fee period to move the original action date of Sept. 30 to the December date, after additional manufacturing data was submitted. An FDA advisory committee voted 10 to 1 on Nov. 18 to recommend the product, although the panel did not endorse a broad claim for otitis media (1"The Pink Sheet," Nov. 23, 2009). European marketing authorization was granted on Dec. 11
Pfizer Restructures For A More Flexible Future
In a move that could position Pfizer for more drastic measures down the road, the pharma giant has reorganized its development and commercial operations into several business units designed to foster autonomy and financial responsibility in the areas of specialty medicine, primary care and emerging markets
Pfizer Plots Major Phase III Push
Lipitor soon to fade; company faces “challenge of a lifetime,” says R&D president.