Bristol Myers Squibb’s ROS1 inhibitor repotrectinib and Janssen Pharmaceutical’s bispecific antibody amivantamab will come up for discussion by a key health ministry panel on August 30 over whether they should be granted regulatory approval in Japan. The Pharmaceutical Affairs Council’s…
To read the full story
Related Article
- Novavax COVID Vaccine to Be Adapted to JN.1 Strain: Takeda
June 10, 2024
- Keytruda/Padcev Filed in Japan for 1st Line Bladder Cancer Treatment: MSD, Astellas
February 1, 2024
- Janssen Files Bispecific Antibody Amivantamab for NSCLC in Japan
November 20, 2023
- AbbVie Japan Files Rinvoq 30 mg Regimen for Age 12-Plus Atopic Dermatitis Patients
November 16, 2023
- UCB Seeks Hidradenitis Suppurativa Nod for Bimzelx in Japan
November 13, 2023
- BMS Files Repotrectinib in Japan for ROS1-Positive NSCLC
October 26, 2023
REGULATORY
- MHLW Lifts Part of Approval Conditions for Takeda’s Vyvanse
June 9, 2026
- Drug Makers Seek Govt Support for Immunoglobulin Plant Investments: LDP Hearing
June 9, 2026
- Japan Govt Likely to Slim Down Honebuto, but Details Remain Elusive
June 8, 2026
- Leqembi, Kisunla Labels Revised to Strengthen ARIA Monitoring
June 8, 2026
- Japan Tightens Oversight of Mounjaro Resales: Health Minister
June 8, 2026
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…





