Japan

Japan H1 Roundup: Forex Impact, Strong Global Mainstays Positive Factors

 

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.

Japan Ventures Progress Cell And Gene Candidates For ALS, Severe Conditions

 
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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.

Biopharma Excellence Celebrated At Citeline Japan Awards

 
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Excellence, innovation, deal-making and personal achievement across the Japanese biopharma sector were celebrated at the Citeline Japan Awards 2024, held in Tokyo on 22 October.

Meiji Considers Legal Action Amid Japan Misinformation On Kostaive Vaccine

 
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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.


Publisher's Spotlight: Shortlist Unveiled For Citeline Japan Awards

 
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Following consideration by our independent expert judging panel, the final shortlist of entries has now been revealed for the Citeline Japan Awards 2024. Join us at the event in Tokyo on 22 October! 

Nxera: Building To Become Japan’s Global Biotech Champion

 

CEO Chris Cargill talks to Scrip about Sosei Heptares’ new identity as Nxera, the ups and downs of being big pharma’s go-to small-molecule drug hunter and its move into commercialization in Japan.

Santen Fortifies Glaucoma Strategy With Sepetaprost Japan Filing

 
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The dual agonist of the FP and EP3 receptors has shown efficacy in a Japanese Phase III trial and completed its US Phase II study, which aligns with the Japanese firm’s global expansion strategy for glaucoma products.

Taisho Makes Japan Vornorexant Filing, Hopes To Dent Insomnia Market

 
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Taisho’s in-house insomnia therapeutic candidate vornorexant offers a potential advantage of a shorter half-life compared to its competitors, which can contribute to patients’ QOL.


Progress Or Hype? A Decade Of Cell Therapy In Japan

 
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After 10 years of promised investment following its Nobel Prize for iPS cell research, Japan is cautiously narrowing regulations around the conditional approval of cell therapies and cutting some reimbursement prices. Commercial success remains mixed and some products have been withdrawn from the market.

Japan Pharma Layoffs: Takeda And Others Implementing Broad Cuts

 
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Several major Japanese firms, including Takeda, are planning layoffs at home and elsewhere as they make efforts to streamline their business and costs and cope with R&D and commercial challenges. 

Japan Results Roundup: Strong Mainstays, Currency Windfall Help Top Line

 
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Results from the top Japanese pharma firms in the fiscal first quarter were marked mainly by strong global performances for mainstay products and significant currency effects due to the continued weakness of the yen, although forex concerns are rising. Eisai's Alzheimer's drug Leqembi also gained momentum, particularly in the US. 

Win Some, Lose Some: Amid Otsuka-Jnana Deal, Delaware Court Favors Lupin For gJynarque

 
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Otsuka Pharma’s acquisition of Jnana seems like a win for its pipeline, but the Japanese major faced a setback in a Delaware District Court where the judge’s opinion put challenger Lupin closer to a generic to its Jynarque (tolvaptan)


Japan Cell Therapy Hopes Hit By HeartSheet Full Approval Hurdles

 
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Despite initial promise, a novel autologous cell transplant therapy for severe heart failure has faced multiple challenges in gaining full approval in Japan, potentially providing learnings for other developers of regenerative medicines.

Chiesi Takes Long View To Build Japan Rare Disease Presence

 
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After expanding its local portfolio through acquisitions and partnerships, Chiesi is now aiming to build its presence in Japan's rare disease sector over the long term, helped by development of global products and possible new alliances. 

PRISM BioLab Completes Successful Tokyo IPO On Back Of Multiple Partnerships

 
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The Japanese drug discovery bioventure builds on multiple alliances and an in-house platform to get away a successful IPO in Tokyo, which it will use to fund further pipeline and technology development.

AnGes To Withdraw, Refile HGF Gene Therapy In Japan

 
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If finally fully approved in its first indication, the HGF gene therapy could become a first-in-class therapy for PAD - but only after years of challenges in clinical trials.


Conditional Global-First Nod For SanBio's Cell Therapy for TBI

 
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SanBio’s lead cell therapy asset has been on a bumpy journey to its global-first approval and while a nod has now come in Japan in a high-need indication, a commercial launch is conditional on additional data to establish product equivalence and manufacturing consistency. 

Multiple Stargardt Contenders Progress In Japan Despite Small Market

 
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With no approved therapies globally for Stargardt's, competition in the indication is increasing in Japan, where Kubota Vision is seeking for conditional approval for emixustat, while Belite Bio’s contender tinlarebant has received Sakigake designation as a local Phase III program continues.

Japan Academia Progresses Novel Melanoma Drug Despite Pharma 'Reluctance'

 
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Academia-developed novel oral PAI-1 inhibitor in combination with Opdivo showed a strong response rate in PD-1 treated melanoma patients with certain disease characteristics and could represent a new breakthrough for a class with no clinical stage competitors. 

Citeline Japan Awards 2024 - Enter Now!

 

The 15 July entry deadline for the Citeline Japan Awards 2024 in Tokyo is fast approaching, so here's a reminder to take a look at the categories and criteria and be sure you get those submissions in by this date. Sponsorship opportunities and tables are also available.