Can A REMS Save Raptiva?

FDA issues an advisory after more confirmed cases of PML, but EMEA takes a harder line, recommending suspended marketing of Genentech’s psoriasis treatment.

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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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Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 

Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

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New CDC Vaccine Panel Chair Vows To ‘Rebuild Public Trust’ With Evidence-Based Medicine

 
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The newly reconstituted Advisory Committee on Immunization Practices will create new work groups to examine the cumulative impact of vaccine schedules and reexamine some older vaccines.