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Under the agreement, DKSH will commercialise four pain medicines on behalf of Grünenthal across eight Asia-Pacific markets and will be responsible for seeking local marketing authorisations.
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The FDA approval is based on Phase 3 data, with 42% of adolescent patients with severe alopecia areata receiving Olumiant 4 mg achieving at least 80% scalp hair coverage at Week 36, compared with 5% on placebo.
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Fresenius Kabi is notifying distributors and customers directly about the recall and is arranging for the return of affected products.
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