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Pirfenidone Advisory Committee Likely To Hinge On Clinical Meaningfulness Of FVC Test
InterMune's case is complicated by fact that statistical significance was met in only one of two pivotal trials.
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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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Generative artificial intelligence tools, such as ChatGPT, have “democratized” AI, and contract research organizations are wholeheartedly embracing these tools, given their focus on efficiency, says Stephen Pyke, who chairs the AI committee at the Association of Clinical Research Organizations.
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Japan gives world-first approval recommendations to two domestically originated drugs, for insomnia and glaucoma/ocular hypertension.
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The FDA could act on 17 applications, including 10 novel agents, during August. Only one would be a second-cycle review.