Boehringer Ingelheim newspaper ad for its COX-2 inhibitor Mobic (meloxicam) implies superiority to Merck's Vioxx and Pfizer/Pharmacia's Celebrex, FDA ad division letter says. The ad's "rhetorical question 'Are You Dissatisfied?' implies clinical superiority of Mobic compared with Vioxx or Celebrex in osteoarthritis," the letter says. The ad also makes unsubstantiated claims about international use of the drug and presents risk information in a manner only comprehensible to healthcare professionals, the Oct. 24 letter says...
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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.’
Eli Lilly's CEO argued that pricing reforms aimed at existing drugs would be “hard to sustain or justify,” while other companies suggested a growing interest in direct-to-consumer sales programs.
New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.
Companies in Europe cannot delay business decision making much longer to wait for more certainty on major US policy shifts on tariffs and pricing.
