REGULATORY
Japan to Set Up Dedicated Team to Expedite Review of Sakigake-Designated Cell/Gene Therapies
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) will establish a team dedicated to reviewing cell and gene therapies designated for its sakigake fast-track pathway in FY2020 as it gears up for a flurry of approvals for these up-and-coming products. Funds…
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The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…





