Latest Japan Approvals Include World-First For Pabinafusp
Other Nods For Vitrakvi, Polivy
A new batch of marketing authorizations in Japan includes new therapies for high-need cancer indications and rare diseases, and the first nod worldwide for a novel lysosomal disorder treatment that can address serious CNS symptoms.
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Denali Therapeutics has reported promising early clinical data in Hunter syndrome for its fusion protein, DNL310, an investigational agent that crosses the blood-brain barrier and is expected to address disease-associated CNS effects; however, some biomarker data disappointed, and there are potential competitors also under development.
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