Grassley Wants An Rx Safety Reorganization; Can FDA Keep Him At Bay Again? Congressional Avandia Investigation Reopens Door On Splitting CDER
Renewed congressional interest in a separate drug safety center at FDA is a likely off-shoot of a Senate Finance Committee report that questions GlaxoSmithKline's handling of cardiovascular safety issues surrounding Avandia
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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.’
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A blanket pricing agreement CSL has formed with German health insurers for the gene therapy, Hemgenix, makes the cost of treatment budget-neutral compared to traditional treatment.
Japan's trade ministry is providing new support to build domestic capacity for new modalities including cell and gene therapies, as part of wider efforts to support the national bioventure ecosystem.
Coverage data from the two programs suggest Medicare beneficiaries may be more disappointed than Medicaid enrollees by the Trump Administration’s decision not to mandate the programs cover obesity drugs.