Latest from Lisa Takagi
Takeda, Astellas, Daiichi Sankyo, Chugai, Shionogi all revised their annual forecasts upwards due to forex rate impact and saw mostly solid overseas sales growth in the fiscal first half.
Along with several new positive approval recommendations, Japan's proceeding to grant Sakigake designation to two drugs including a DMD gene therapy discovered through public collaboration. Meanwhile, the PMDA has opened a new full-time office in the US.
Decision contrasts with successful journey in the US, where it was approved with Fast Track designation in 2023. Astellas says its considering “every potential action” to bring GA drug to patients in Europe.
Japan is cautiously easing Japanese clinical data requirements for rare disease drugs to allow faster and more flexible approvals, including on a conditional basis supported by postmarketing studies.
Plus deal news involving LianBio/NImmune, REGiMMUNE/Kiji, Chengdu Baiyu/Novartis, Orasis/Optus, Takeda/Wave Life Sciences, Ono/LigaChem, Alchem/Sonnet, Astellas/AviadoBio, Innovent/Ask Pharm and Dr Reddy’s/Gilead.
Multiple Japanese ventures presented updates on their novel pipeline assets and modalities at BioJapan, including cell and gene therapies and combination treatments, despite lingering financing challenges.