Latest from Lisa Takagi
Kyorin signs in-licensing agreement with UBE to grow its new drug pipeline as it chases mid-term deal target.
Japan's regulatory authorities recommend approval of products including a cell therapy, while setting reimbursement prices of newly approved drugs and cutting some others following cost-effectiveness assessment.
Plus deals involving Rapport/Tenacia, Servier/Kyron.bio, Pfizer/Aska, TransCode/Unleashed Immune Oncolytics, Gedeon Richter/Celmatix and recent AI/ML-focused alliances.
Daiichi Sankyo’s MMR Vaccine, Ultragenux’s triheptanoin also won approval recommendations.
Idvynso, Merck & Co.'s oral once-daily combination of doravirine and Japan-originated molecule islatravir, has been granted its global-first approval in Japan, ahead of the US.
Japan's regulatory authorities are implementing a number of updates and revisions to the national drug law in measures designed to address shortages of high-demand products and clarify guidance in areas including conditional approvals.
