The most serious adverse events (perforations, obstructions or bleeds) in rofecoxib clinical trials (n=3,357) were described at an April advisory committee meeting by Merck Gastrointestinal Clinical Research Executive Director Thomas Simon, MD, as "18 events...17 of them were bleeds, nine were confirmed. Of these confirmed bleeds, five were complicated. Eight of them were unconfirmed. Of these unconfirmed events, three were complicated" by prespecified criteria. "There was one case of gastric outlet obstruction; there were no perforations." "The Pink Sheet" incorrectly reported a patient death from obstruction (April 26, p. 9). Efficacy in osteoarthritis was described as equivalent to ibuprofen 800 mg t.i.d. for the 25 mg q.d. rofecoxib dose; the 12.5 mg dose was also equivalent
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
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.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.
