Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) concluded FY 2024‑25 (April 2024–March 2025) with a total of 148 approval decisions, including no less than 66 new active ingredients and 82 lifecycle updates, including new indications, pediatric expansions, and formulation changes. Innovation Snapshot A…
A roundup of the most important stories coming out of Japan’s pharma industry, including the sharp increase in deaths linked to Kobayashi supplements; the partnership between Moderna and Mitsubishi Tanabe…
Writing in the September 2025 edition of DIA’s Global Forum magazine, Seiko Usami, Shinichi Noda, Daisuke Koga, and Naoyuki Yasuda of the Pharmaceuticals and Medical Devices Agency (PMDA), Japan’s regulatory…
In an era of rapid scientific breakthroughs, global regulators are navigating new challenges—accelerating approvals, harmonising standards, and integrating digital tools—while balancing safety, efficacy, and access. Throughout 2024, PharmaBoardroom spoke with…
Asia is emerging as a critical frontier in oncology research, yet much of global drug development continues to overlook the region’s specific clinical needs. At the National Cancer Center Japan,…
In conversation at DIA Europe 2024 in Brussels, Shinobu Uzu of Japan’s regulatory agency, PMDA, laid out the organisation’s new five-year plan, how PMDA is hoping to incentivise more biopharmaceutical…
Experienced global leader Takafumi Horii explains the rationale behind returning to his home nation of Japan to head up Takeda’s Japan Oncology operations. Horii also touches on the significant burden…
After 12 years at the helm, Takeda CEO Christophe Weber is stepping down, leaving behind a transformed company. Under his leadership, Japan’s biggest drugmaker expanded globally with the $62 billion…
A summary of some of the biggest stories coming out of Japan’s pharma industry, including Teva’s divestment of joint venture Teva-Takeda; GE HealthCare’s takeover of Nihon Medi-Physics; Takeda’s blood cancer…
At this year’s FT Live Global Pharma and Biotech Summit, Takeda’s President and CEO Christophe Weber spoke about the increased challenges for healthcare systems. Weber acknowledged that as cost pressures…
Japan was once a global leader in life sciences innovation, introducing about a third of the world’s new drugs in the 1980s, but this positioning slipped following decades of economic…
Japan’s amended Cannabis Control Law now permits the development and medical use of cannabis-derived drugs, particularly CBD-based treatments, while simultaneously criminalizing self-use of smokable cannabis products. Writing in the February…
Santen is on a mission to reshape the future of eye health. With three major product launches ahead, bold biotech deals, and a revamped global strategy, the Japanese pharma is…
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