Latest From FibroGen Inc.
The latest batch of product approvals in Japan positions Astellas’s roxadustat as the pioneer in the country’s potentially large HIF-PH inhibitor market in anemia, while Takeda and Meiji Seika see other important approvals and the first biosimilar teriparatide receives a nod.
AstraZeneca paid $95m to Swedish Orphan Biovitrum for the voucher, which it could use to expedite the FDA review of roxadustat or trastuzumab deruxtecan.
Competition intensifies in novel anemia therapy space in Japan with first filing globally for Akebia/Mitsubishi Tanabe’s contender vadadustat, which could see its first launch worldwide in the country.
Japanese firms unveil pivotal top-line results that pave way for first filing of novel anemia therapy within new class of agents, but competition is high and timings remain unclear.
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James A Schoeneck, Interim CEO
Pat Cotroneo, VP, Fin. & CFO
David M Dimmick, MD, VP, Quality
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AI Lin, MD, PhD, VP, Drug Dev.
Peony K Yu, CMO
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