Tylenol use in alcoholics: The recommendation by some practitioners that alcoholics avoid use of acetaminophen or decrease their daily dose "is not supported by prospective data," Edwin Kuffner, MD, Rocky Mountain Poison & Drug Center, Denver Colo., et al., find. The prospective placebo-controlled trial was presented at the American Society for Clinical Pharmacology & Therapeutics annual meeting in Orlando, Fla. March 2-5. The authors followed 385 alcoholics for three days, giving 262 of the patients 4 g/day of acetaminophen while the other 123 patients received placebo. "Alcoholics treated with the maximal daily recommended dose of [acetaminophen] for three days did not develop liver injury," the authors maintain...
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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 European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.
The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.
The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.