Bextra Will Not Return To Canadian Market
This article was originally published in The Pink Sheet Daily
Executive Summary
Health Canada cites increased risk of cardiovascular events associated with Pfizer’s COX-2 inhibitor.
You may also be interested in...
Health Canada Requests Labeling Change For All NSAIDs
The agency will issue guidance to manufacturers on what risk/benefit information should be included in product labeling. Canadian advisory committee recommends uninterrupted marketing of Celebrex, reintroduction of Vioxx and continued marketing prohibition of Bextra.
Bextra Pulled From Market, But Pfizer Hopes To Explore Other Options
Pfizer is characterizing FDA's request for a withdrawal of Bextra as a "marketing suspension"; the company hopes to continue discussions on how valdecoxib could re-enter the market. Increased cardiovascular risk plus a "special risk" of serious skin reactions led FDA to recommend pulling the COX-2 inhibitor.
Metsera Launches As New Obesity Contender Flush With $290m
Clive Meanwell, former CEO of The Medicines Company, will helm the new company, backed by ARCH and other investors. He talked to Scrip about the new venture.