Tagged with japan

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 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 R&D in the country, and why Japan is “the gateway to Asia” in regulatory terms.   International pharmaceutical companies [should]…

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…

APAC The latest pharma and healthcare news from APAC, including Celltrion’s plans to sell its Takeda portfolio to CBC; reforms to the South Korean national insurance system that may lead to shorter reimbursement timelines; Novartis’ early-stage HDAC6 Inhibitor deal with Chong Kun Dang Pharmaceutical; Astellas Pharma’s gastric cancer FDA fail; Daiichi…

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 Japan is known for its cutting-edge technology, innovative products, and world-class healthcare system. The pharmaceutical industry in Japan is no exception, with many leading companies making significant contributions to global health and wellness. Read on for a rundown of the top 10 Japanese pharmaceutical companies (based on market capitalisation in…

Japan An overview of the new medicines approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) between April and November 2022. See the 2021 data here and the full PMDA approval archive here. Hecho conVisme Infographic Maker

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…

Pharma Legal Handbook The key facts about biosimilars and biologics in Japan. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here.   1. Are biosimilar medicines considered the same as generic medicines in your country? A…