The Risks Of Surrogacy: Egrifta Faces Twofold Challenge At Advisory Committee
• By The Pink Sheet Daily
Theratechnologies will need to address FDA's concerns about whether a reduction of patients' visceral abdominal fat produced by the HIV lipodystrophy product has clinical meaning and is worth the risks.
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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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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.
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.