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Global Pharma Guidance Tracker – September 2024

Global Pharma Guidance Tracker – September 2024

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Publisher's Spotlight: Shortlist Unveiled For Citeline Japan Awards

Publisher's Spotlight: Shortlist Unveiled For Citeline Japan Awards

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! 

Generics Push Continues With New Measures In Japan

Generics Push Continues With New Measures In Japan

Japan has started to charge patients a portion of the difference between the reimbursement price of the generic and non-generic product if they insist on the latter without a supporting recommendation from the prescribing physician, in a policy designed to further drive generic use.

Japan Patients To Pay Part Of Price Difference When Insisting On Branded Drugs

Japan Patients To Pay Part Of Price Difference When Insisting On Branded Drugs

Japan has started to charge patients a portion of the difference between the reimbursement price of the generic and non-generic product if they insist on the latter without a supporting recommendation from the prescribing physician, in a policy designed to further drive generic use.

Nxera: Building To Become Japan’s Global Biotech Champion

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

Santen Fortifies Glaucoma Strategy With Sepetaprost Japan Filing

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.

Japan Plans To Smooth Trial Pathway For Foreign Ventures

Japan Plans To Smooth Trial Pathway For Foreign Ventures

Japan plans to offer wider support to foreign firms and ventures with innovative candidates to start clinical trials in the country, as part of key measures from current prime minister Fumio Kishida.

Taisho Makes Japan Vornorexant Filing, Hopes To Dent Insomnia Market

Taisho Makes Japan Vornorexant Filing, Hopes To Dent Insomnia Market

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.

Regeneron Sets Out Timing Expectations For Dupixent Biosimilars

Regeneron Sets Out Timing Expectations For Dupixent Biosimilars

At the recent Morgan Stanley Healthcare Conference in New York, Regeneron management set out expectations for when the firm would begin to face competition to its $12bn-and-growing Dupixent eczema and asthma treatment from dupilumab biosimilars in the US, Europe and Japan.

Easing Market Entry: Japan’s PMDA Allows Approval Filings In English

Easing Market Entry: Japan’s PMDA Allows Approval Filings In English

Non-Japanese firms without offices in the country may submit documents for approval filings in English, subject to certain conditions.