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Reading the Register: What Japan's Provision Plans Actually Say

A register, not an approval list Start with the thing that is most often got wrong, including by people who should know better. The Act on the Safety of ...

August 10, 2026 | Analysis

Ono and Mediar Partner to Develop Novel Antibody Therapies for Fibro-Inflammatory Diseases

Commencing a drug discovery partnership to create novel antibody therapeutics for fibro-inflammatory diseases with high unmet medical need Leveraging ...

August 10, 2026 | News

Adneuris Licenses Cebranopadol Rights to Maruishi for Japan and South Korea

Agreement Grants Maruishi Rights for the Development and Commercialization of Cebranopadol for Pain in Japan and South Korea, Marking Adneuris' Second Ex...

August 07, 2026 | News

EU CHMP Backs Enhertu Plus Pertuzumab as First New First-Line HER2 Positive Metastatic Breast Cancer Treatment in Over a Decade

Recommendation based on DESTINY-Breast09 phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk of disease progression or death by ...

July 28, 2026 | News

OrbusNeich Enrols First Patient in Pivotal Japanese Trial of Coronary Drug-Coated Balloon

OrbusNeich Medical Group Holdings Limited (“OrbusNeich” or the “Group”; stock code: 6929), a multinational medical device comp...

July 28, 2026 | News

7 Countries Competing to Be the Region’s Next Biomanufacturing Hub

A siting decision for a biomanufacturing facility is one of the most expensive commitments a company makes, and it is made against a fifteen to twenty year...

July 27, 2026 | Analysis

GHIT Fund Invests JPY 140M to Accelerate Portable Rapid Diagnostic System for Ebola

The Global Health Innovative Technology (GHIT) Fund announced an investment of JPY 140 million (approximately USD 862,000) in a project to develop a portab...

July 24, 2026 | News

Rege Nephro Raises $10.6M to Advance iPS Cell-Based Kidney Disease Pipeline

inancing will support development of RN-014 and RN-032 and continued expansion of the company's kidney disease pipeline Rege Nephro Co., Ltd. ("Rege Nephr...

July 22, 2026 | News

Japan Looks Beyond Its Borders to Build the Next Generation of Biotech Innovation

Japan’s biotechnology sector is entering a new phase in which scientific strength alone may no longer determine success. As drug development becomes ...

July 20, 2026 | News

Telix Advances Illuccix Towards Japan Approval After Completing Phase III Patient Enrollment

Completed enrollment of 105 patients in Phase 3 registration study of TLX591-Px (Illuccix®) for prostate cancer imaging in Japan. The study data wil...

July 20, 2026 | News

Novonesis, TurtleTree Join Forces to Scale Precision-Fermented Lactoferrin for Global Nutrition Markets

Novonesis, a global leader in biosolutions, announced an agreement with TurtleTree, an innovator in precision fermented ingredients, and the first company ...

July 20, 2026 | News

ACROBiosystems Secures Japan PMDA Confirmation for GMP-Grade IL-15 Used in Cell Therapy Manufacturing

ACROBiosystems has officially received the "Material Suitability Confirmation for Regenerative Medicine Products" (Certificate No.: 薬機審長発第47号...

July 16, 2026 | News

Boostimmune Secures Japanese Patent for TCTP-Targeting Antibody Technology to Advance Cancer Immunotherapy

Japanese patent granted for technology that inhibits TCTP released from dead tumor cells using antibodies to suppress the accumulatio...

July 15, 2026 | News

Pfizer and Astellas Expand FDA Approval of PADCEV Plus Keytruda Across All Muscle-Invasive Bladder Cancer Patients

Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) announced that the U.S. Food and Dru...

July 14, 2026 | News

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