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REGULATORY
- PMDA Chief Mulls Requiring Few-Year Clinical Background for Reviewers
June 12, 2019
- PMDA to Form Panel on Relief System to Ensure Access, Quick Remedy
June 11, 2019
- MHLW Study Group Drafting Guidelines for New Dyslipidemia Drug Development, First in 30 Years
June 11, 2019
- Deregulation Panel Proposes Giving Private Companies Access to National Health Database to Promote New Drug Development
June 10, 2019
- MHLW Vaccine Panel Discusses Inclusion of Rotavirus Vaccine in Public Vaccination Programs; Has “Enough Data”
June 7, 2019
- Shock, Anaphylaxis Added to Xofluza’s ADR List; Label Changes for Checkpoint Blockers
June 5, 2019
- MHLW Panel Approves to Contraindicate Metformin in Impaired Kidney Function Patients with eGFR less than 30
June 4, 2019
- Reborn PMDA Boots Up under New Skipper, Bolstering “Patient First” Initiatives
June 4, 2019
- Kampo Industry Expresses Concerns over Copay Hikes, Narrow Definition of Essential Drugs: LDP League
June 3, 2019
- Bayer’s Larotrectinib, Novartis’ Capmatinib Get Orphan Status in Japan
June 3, 2019
- June Approval Likely for Chugai’s NTRK-Gene Targeting Entrectinib, 2nd Tumor-Agnostic Drug
May 31, 2019
- LDP Junior Politicians Set Up Vaccine Study Group
May 31, 2019
- “Drugs for Specific Use” Might Include NTD Medicines: MHLW Official
May 30, 2019
- Chuikyo Subcommittee Agrees on Discussion Timeline, Topics for 2020 Drug Pricing Reform
May 30, 2019
- MHLW Panel OKs Public Knowledge-Based Applications for Add’l Indication for Rituxan
May 30, 2019
- Japan Approves Health Coverage for Cancer Gene Panel Tests
May 30, 2019
- Alnylam’s RNAi Drug Now in Line for Japan Approval in June
May 29, 2019
- Japan’s 2nd Enbrel Biosimilar, Pfizer’s Herceptin Follow-On Get Listing
May 28, 2019
- Quizartinib Added to List of MHLW Panel Review on May 30
May 24, 2019
- LDP’s Life Science Study Group Eyes Enhancement of Databases, AMED Functions
May 23, 2019
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In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
