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Lilly Prasugrel Beats Plavix In TRITON, But Bleeding Data Raise Questions
Eli Lilly released powerful efficacy results from an eagerly anticipated Phase III head-to-head trial of its experimental antiplatelet agent prasugrel, which has the potential to take market share from Bristol-Myers Squibb's blockbuster Plavix (clopidogrel)
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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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PharmaMar has voluntarily withdrawn its marketing authorization application for Aplidin to treat multiple myeloma in the EU – almost a decade after it first filed the drug for EU approval and following years of court proceedings.
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Antibiotics that tackle antimicrobial resistance are to be automatically included in Italy’s Innovative Medicines Fund, which is designed to provide quick access to innovative medicines.
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The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.