Latest from Lisa Takagi
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.
Dispute around the first-in-world license for a self-amplifying mRNA COVID-19 vaccine castes light on Japan’s ongoing dilemma between a government trying to build its own capabilities to attract, develop and manufacture new modalities and the anti-vax movement in the country.
Japanese distributor Meiji Seika Pharma is considering possible legal action against what it views as online slander around COVID-19 vaccine Kostaive, which received its global-first approval in Japan last year and has now been launched for regular vaccination in the country.