Japan Approvals Include World-First For Skyrizi, Kymriah As Asia's First CAR-T
Japan approves a large batch of new products including significant first nods globally for AbbVie's antibody for psoriasis and Japan's first gene-based therapy, as well as a pioneering first approval in Asia for a CAR-T drug.
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Looking back on the top stories about Japan in Scrip and the Pink Sheet over 2019, it is hard to avoid the continued dominance of corporate transactions - in particular those involving Takeda.
The healthcare giant is looking for a second approval for its IL-23 blocker and tells Scrip the results from the DISCOVER program show that the drug can make its mark in psoriatic arthritis as well as psoriasis.
The main priorities for the new chief executive of Japan’s drugs regulator over the next five years include putting patients first by promoting early access while ensuring safety, further strengthening pharmacovigilance as new forms of therapy come through, and increasing collaboration with Asia, as the agency looks to meet the challenges of changing technologies.