REGULATORY
Orphan Status for Otsuka’s Sakigake-Designated Product, and 4 Other Cell and Gene Therapies Endorsed
A Japanese expert panel backed the awarding of orphan drug status for Otsuka Pharmaceutical’s gene therapy TBI-1301 for the treatment of synovial sarcoma, and four other regenerative medicine products by holding discussions in a round-robin method, the health ministry said…
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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…





