REGULATORY
Shock, Anaphylaxis Added to Xofluza’s ADR List; Label Changes for Checkpoint Blockers
The Ministry of Health, Labor and Welfare (MHLW) on June 4 ordered label revisions related to adverse reactions for a batch of drugs including Shionogi’s novel flu drug Xofluza (baloxavir marboxil) and immune checkpoint inhibitors. Xofluza will add shock and…
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REGULATORY
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We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…





