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
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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.’
Highlights from day one of the BIO convention include advice for firms hoping to go public, a call for companies to push the US Congress on rare disease priority review vouchers, and updates on next-generation gene therapies.
Lupin became the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster.
The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.
