Statins are primary Part D generic casualty: The Medicare Part D prescription drug benefit had negligible impact on generic utilization rates, according to a preliminary analysis of Walgreens claim data by James Zhang, Virginia Commonwealth University, and colleagues. In a June 23 presentation at the American Society of Health Economists meeting in Durham, N.C., Zhang reports that the odds ratio of generic utilization for Medicare eligible patients, defined as subjects ages 67-73 in 2006, relative to non-Medicare seniors, subjects ages 61-63, was .98. Authors estimate that potential costs to Medicare due to foregone generic substitutions were $2.1 billion in 2006. Antihyperlipidemics is the only drug class with statistically higher generic utilization for the Medicare-eligible population, the authors report. Merck's blockbuster cholesterol agent Zocor (simvastatin) was a primary focus of insurer generic substitution efforts when the statin lost market exclusivity in June 2006, the first year of the drug benefit (1"The Pink Sheet," July 30, 2007, p. 16). In a separate presentation at ASHE, IMS Health Senior VP-Corporate Strategy Murray Aitken reports that generics account for the same percentage of scripts inside and outside of Part D
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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.’
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.
