COX-2 Rx ARTHRITIS AGENT TESTING SHOULD INCLUDE LOW-DOSE ASPIRIN USERS as a special subpopulation, FDA's Arthritis Advisory Committee agreed at a meeting on COX-2 inhibitor safety issues held in Gaithersburg, Md. March 24. Committee member David Yocum, MD, University of Arizona, said he is "concerned about combination therapies" after hearing data that regular low-dose aspirin use leads to a higher risk of gastrointestinal complications. COX-2 inhibitors also are suspected of causing GI problems. Believed to be the next generation of arthritis drugs, COX-2 agents act as anti-inflammatories through their selective inhibition of the cyclooxygenase-2 protein. Searle, Merck and Boehringer Ingelheim are developing COX-2 products for Rx sale.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
There is a place for using external reference pricing to set prices of advanced therapies, but any such mechanism must take into account the specificities of the Brazilian market and health system.
Lerodalcibep and palbociclib are among the latest new drugs that the European Medicines Agency has started to review for potential EU marketing authorization.
Country recommends eights new drugs for approval, including six for rare diseases, and also announces macroeconomic policy the pharma industry says would enable some reimbursement prices to be raised.
