REGULATORY
Japan Backs Calquence-Venclexta Regimen for Untreated CLL via Label Updates
Japan has updated the labels of AstraZeneca’s Calquence (acalabrutinib) and AbbVie’s Venclexta (venetoclax) to support their combination use in previously untreated chronic lymphocytic leukemia (CLL), reflecting the positive results from the global PIII AMPLIFY trial. The Pharmaceuticals and Medical Devices…
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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…





