"Regular, but not intermittent, ibuprofen may abrogate the benefits of aspirin when used for secondary prevention of acute myocardial infarction," a study in the August Journal of Rheumatology finds. The retrospective cohort study followed patients at least 66 years old who were hospitalized for MI between January 1992 and March 1999. Patients were followed for one year after their MI while on an aspirin regimen. A total of 18,503 patients were included; ibuprofen was dispensed to 372 patients while others received scripts for NSAIDs such as naproxen and diclofenac, or took no NSAID. There was an "increase in the rate of recurrent MI in patients taking ibuprofen and aspirin compared to those taking aspirin alone as the duration of exposure increased," state Marie Hudson, McGill University, et al. In contrast, those taking naproxen and aspirin had a "lower rate of recurrent MI compared to those taking aspirin alone"...
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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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The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.
The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.