Japan Writing in DIA’s Global Forum magazine for April 2024 on behalf of DIA Japan’s Open Innovation Community Fumitaka Noji, Takeshi Kono, and Makoto Nagaoka look at how the gap between Japan’s academia and pharma companies can best be bridged to fully reap the benefits of innovation.   Although open innovation in drug…

Japan Toshi Tominaga of Keio University Hospital, writing in the January 2023 edition of the DIA Global Forum magazine, outlines some recent updates to Japanese drug registration legislation, including how domestically generated academic clinical data can be utilised.   Japan’s current regulatory framework for investigator-initiated trials (IITs) of drug candidates seems…

Japan Real-world data (RWD) offers the possibility of providing important information to help inform regulatory decision-making. But turning this possibility into reality still depends on the quality and reliability of the data, say J&J’s Yumi Wakabayashi and Vicky Han in October 2023’s DIA Global Forum magazine. With appropriate efforts to ensure…

Japan In the five years since the Japanese drugmaker began a strategic shift and created an ambitious plan to maintain growth, CEO Kenji Yasukawa helped Astellas move away from its previous business model and bounce back from failing revenues. With the appointment of former chief strategy officer Naoki Okamura as its…

Japan Writing in the February 2023 edition of DIA’s Global Forum magazine, Yumi Wakabayashi of Janssen, Takahiro Horimatsu from the Institute for Advancement of Clinical and Translational Science at Kyoto University, Hiroshi Asai of Astellas, Yasuhiro Himeno from the Government of Japan’s Cabinet Office, and Hiroyuki Taruno of the Cancer Institute…

Japan MSD KK’s Fumitaka Noji, writing in the January 2023 edition of DIA’s Global Forum magazine, outlines some of the key upgrades that Japan’s innovation ecosystem needs to become globally competitive once again, namely around strategy and information, investment, and finding qualified experts.   Although the importance of open innovation in…

Japan Pfizer’s Kaneko Miyuki, writing in the September 2022 edition of DIA’s Global Forum magazine, shines a light on Japan’s new emergency approval system for pharmaceuticals. Enacted in the wake of the COVID-19 pandemic, Japan hopes that this new regulation will allow for a more rapid and agile response to future…

Japan The latest healthcare and pharma news from Japan, including Shionogi’s COVID-19 pill, the Japanese parliament’s green light for emergency approvals of drugs and vaccines and Hitachi’s partnership with Invivoscribe.   Shionogi’s COVID-19 pill  (Reuters) The future of Shionogi & Co Ltd’s experimental treatment, S-217622, is still uncertain. The company recently…

Japan Japanese firm Kirin, part of the Mitsubishi Group and best known for its brewing operations, has pledged to invest JPY 100 billion (USD 870 million) into its healthcare/pharma operations amid a slowdown in the Japanese beer market.   Beer Today, Gone Tomorrow Japan’s rapidly ageing population and the effects of…

Japan A roundup of the latest news from Japanese pharma, including Kirin’s USD 870 million investment in its healthcare and pharmaceuticals businesses over the next three years, Sanofi’s world-first approval for its Niemann-Pick types A/B and B medicine in Japan, and the prospect of domestically developed COVID-19 vaccines being rolled out…

Japan Writing in the October edition of DIA’s Global Forum magazine, Chief Executive of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) Yasuhiro Fujiwara outlines how his agency has begun to utilise real-world data (RWD) and real-world evidence (RWE) in its regulatory decision-making processes and how this will evolve moving forward.  …

Japan Writing in the August edition of DIA’s Global Forum, Kotone Matsuyama of the Nippon Medical School gives a run-through of Japan’s response to the COVID-19 pandemic, from the organisation and communication of the country’s public health apparatus to the rollout of treatments and vaccines and the growing use of remote auditing…