Latest from Lisa Takagi
Plus deals involving Zai Lab/Pfizer, Laekna/Lilly, Takeda/Alloy, Lunit/AstraZeneca, VelaVigo/Avenzo, Biosion/Aclaris, HCW/WY Biotech, Celltrion/iQone and Kaken/Numab.
While Japan awarded relatively high premiums to several products newly listed for reimbursement, others were the subject of prolonged debate or are facing imminent cost-effectiveness assessment.
Japan has granted an initial reimbursement price for Kisunla slightly above that for Alzheimer's rival Leqembi, but is holding out the prospect of future price revisions.
Astellas's C5 inhibitor faces another approval challenge, this time for a supplemental filing in the US, following the withdrawal of a European submission, although it continues to do well in what is its only market so far.
Plus deals involving Nippon Shinyaku/Atsena, Daiichi Sankyo/Alteogen, Santen/Arctic Vision, Henlius/SVAX, Nxera/Antiverse, Y-mAbs/Nobelpharma, Formosa/DAVI, Mochida/United Therapeutics, GSK/Chimagen and GC/Novelty Nobility.
Japan has implemented a streamlined regulatory system designed to enable speedier approvals of selected drugs for designated categories of infectious diseases, which does not require Japanese clinical data.