Japan

Otsuka’s Centanafadine Edges Closer To US Nod Following Priority Review

 
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US priority review for Japanese firm's first-in-class ADHD drug could result in approval of a new option this year.

perspectives 2026

2026 Japan Cell Therapy Landscape: Ventures To Gain Presence With NDAs, IPOs

 
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While several companies await regulatory approval decisions on their cell therapies in Japan, BioCardia proceeds with discussions on an NDA filing and Innovacel readies an IPO.

Japan Industry Group To Help AMED Bridge Academic Studies And Early R&D

 
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Japan's main pharma industry association to assist government agency's early research and drug discovery projects by providing expertise.

Pfizer Cashes In ViiV Stake With Shionogi Sale For $1.88bn

 

The US giant is narrowing its focus on obesity and cancer.


Hisamitsu To Go Private For Long-Term Growth Through $2.6bn MBO

 
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Hisamitsu's CEO is taking the Japanese firm private through a management buyout aimed at securing future growth.

Shionogi Expands Rare Disease Portfolio With $2.5bn Radicava Buy From Tanabe

 
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Bain Capital will get back a large chunk of the $3.3bn spent on acquiring Mitsubishi Tanabe through the divestment of the firm’s best-selling product to Shionogi, which will accelerate its diversification away from infectious diseases in the process.

RegCell Looks To Bridge Japan-US Expertise As It Builds Treg Cell Capabilities

 
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The firm founded by Treg cell discoverer Shimon Sakaguchi is building up its US team and refining R&D strategy and manufacturing processes to create an example and global path for other Japanese ventures.

Oncolys’s 20-Year Journey To First Approval Filing

 
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Oncolys reaches hard-won milestone with an approval filing in Japan for its oncolytic virus therapy telomelysin through the sakigake pathway, with the Japanese venture eyeing its first commercial launch in 2026.


Sibeprenlimab’s US Accelerated Approval Drives IgAN Competition Forward

 
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Following US approval of its first-in-class drug for IgAN sibeprelimab, Otsuka is planning an sNDA for an autoinjector in 2026 and is in talks with regulatory authorities in Japan and Europe.

J&J Sets Sights On Robust Japan Growth While Tightening Focus

 
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Setting its focus on oncology, immunology and rare diseases, the firm anticipates double-digit growth for 2030.

Japan H1 Roundup: Pipeline Shifts Bring Mixed Results

 
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While Astellas and Daiichi Sankyo rang in double-digit growth, Eisai offset LOE impact with Leqembi’s performance. Takeda struggled with negative results but announced several growth initiatives.

Japanese Bioclusters Aim To Build Communities For Global Success

 
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Japan's leading bioclusters tell a session at BioJapan that building a tight-knit community will help better connect different players in the startup ecosystem and help ventures grow and expand internationally.


Industry Excellence Celebrated At Citeline Japan Awards

 
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Excellence, innovation and deal-making across the Japanese biopharma sector were celebrated at the Citeline Japan Awards 2025, held in Tokyo on 21 October.

Viatris Looks To Expand Japan Presence With Aculys Acquisition

 
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Global generics-focused giant acquires Japanese venture with late-stage, two-asset CNS pipeline as it looks to build presence in Japan.

Zolbetuximab Loses GLEAM In Pancreatic Cancer

 
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Astellas's first-in-class CLDN18.2-targeting antibody has missed its primary endpoint in a Phase II trial for pancreatic cancer and is facing increasingly fierce same-class competition in this and other indications.

Sakaguchi’s Nobel Brings Cheer To Japan Biopharma

 
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Japan's latest Nobel Prize win sparks hopes for renewed investment in biopharma R&D by the national government, including in a venture co-founded by the winner.


Japan’s Cell Therapy Quest Goes On Despite Takeda, Novo Withdrawals

 
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Japan continues to see promise in iPSC and other cell therapies, despite two major firms recently announcing their withdrawal from the area and other setbacks.

US Confirms 15% Tariff On Japanese Drugs, But Confusion Lingers

 
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After tough negotiations which won the country a lower US levy on pharmaceuticals, there still appears to be some confusion within the Japanese government following President Trump's latest announcement on global pharma tariffs.

Publisher’s Spotlight: Shortlist Unveiled For Citeline Japan Awards

 
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Shortlists of potential winners in all categories of the Citeline Japan Awards 2025 have now been released. Join us at the event in Tokyo on October 21, it’s not too late to book your table!

Mitsubishi Tanabe Names New CEO In C-Suite Reshuffle

 
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Under new owner Bain Capital, the Japanese firm is aiming to regain its global presence, helped by new top executives formerly with Pfizer Japan and Takeda.