Japan
What Eight APAC Regulators Have Actually Published on AI in Drug Development
Ask a regulatory affairs lead in Tokyo, Seoul or Singapore what the rules are for using a machine learning model in a drug submission, and the honest answe...
October 21, 2026 | Analysis
PharmaEssentia Accelerates Global Expansion with US and Japan Drug Approvals and US$46 Million Manufacturing Investment
PharmaEssentia Corporation (TWSE: 6446), a Taiwan-based biopharmaceutical company, is expanding its global presence through new drug approvals, clini...
October 21, 2026 | News
How Long It Takes to Start a Clinical Trial in 8 APAC Markets, Timed
If you are building a 2027 trial budget this month, you are probably working from a spreadsheet with one row per country and a column headed "start-up". Mo...
October 19, 2026 | News
Takeda’s First-in-Class Narcolepsy Drug ORZEYFUL Enters Japan and China Markets Following Regulatory Approvals
ORZEYFUL is now available in Japan and China following approvals within a month of each other by China’s National Medical Products Administration (...
October 16, 2026 | News
CellFiber Launches Zeito™ Cell Fibre Fabrication Systems in Japan and US to Advance Cell Therapy Manufacturing
CellFiber, a biotechnology company specialising in cell and gene therapy technologies, has announced the official launch of its Zeito™ series of cell...
October 09, 2026 | News
Ajinomoto Bio-Pharma Services Unveils Refreshed Global Brand Identity
Reflects the depth of expertise and innovation Aji Bio-Pharma brings to customers navigating increasingly demanding development and manufacturing challen...
October 07, 2026 | News
Ractigen Reports First Human Proof-of-Mechanism for RNA Activation in Duchenne Muscular Dystrophy
First clinical evidence demonstrating that a systemically delivered small activating RNA (saRNA) can safely upregulate an endogenous target protein in hu...
October 05, 2026 | News
Turbine, Daiichi Sankyo Expand Virtual Biology Collaboration to Accelerate ADC Discovery
Turbine, a leading virtual biology company, announced the expansion of its collaboration with Daiichi Sankyo following the successful completio...
September 25, 2026 | News
Astellas Doses First Patient in Phase 3 Trial of Setidegrasib for KRAS G12D-Mutated Lung Cancer
Study evaluates novel, investigational KRAS G12D-targeted protein degrader setidegrasib versus docetaxel in previously treated patients with advanc...
September 25, 2026 | News
Sovargen Doses First Patient in Phase Ib/IIa Trial of Kazia’s Paxalisib for Rare Epilepsies
- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused biotechnology company developing therapies that selectively reprogram cancer biology,...
September 24, 2026 | News
Daiichi Sankyo, AstraZeneca’s Enhertu Wins EU Panel Backing for Early Breast Cancer
Recommendation based on DESTINY-Breast05 phase 3 trial results that showed Enhertu reduced the risk of invasive disease recurrence or death by 53% vers...
September 21, 2026 | News
Japan Approves Lundbeck’s Eptinezumab for Migraine Prevention in Adults
Approval granted by Japan's Ministry of Health, Labour and Welfare (MHLW) Eptinezumab is the only intravenous (IV) CGRP-targeted preventive treatment ap...
September 18, 2026 | News
Ferronova’s Nanoparticle Platform Shows Promise for More Precise Gastric and Oesophageal Cancer Surgery
Australian medical technology company Ferronova has announced preliminary findings from the MAGMAP multi-centre trial involving 62 gastric and oesopha...
September 17, 2026 | News
Takeda’s Zasocitinib Receives US FDA Priority Review for Plaque Psoriasis
-Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) under Priority Review for za...
September 16, 2026 | News
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