As Japan gears up for its next drug pricing reform in April 2020, Shoji Kono, director of the National Federation…
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REGULATORY
- Chugai’s Entrectinib Up for Review for NTRK Tumors on May 30; Label Expansions for Lynparza, Cyramza Also on Agenda
May 17, 2019
- MHLW Compiles Optimal Promotion Guidelines for Kymriah
May 16, 2019
- Coefficients for Cost-Based Pricing Formula Updated: Chuikyo
May 16, 2019
- As Kymriah Fetches Highest List Price, Policymakers Talk over Difficulty in Cell Therapy Pricing
May 16, 2019
- Alnylam’s siRNA Drug Patisiran Up for MHLW Panel Review on May 28
May 16, 2019
- Japan OKs Listing of Trelegy, Erleada, and More; GSK’s COPD Hopeful to Face Cost-Effectiveness Analysis
May 15, 2019
- Opdivo to Face CEA-Based Price Tweaks on Aug. 1
May 15, 2019
- Kymriah Gets 33.5 Million Yen Price Tag, Peak Sales Put at 7.2 Billion Yen
May 15, 2019
- 87% of Drug Makers Say 2018 Pricing Reform Hit Their R&D, Businesses: MHLW Survey
May 15, 2019
- Newly Sworn In Chief Gives “4 First” Pep Talk to PMDA Staffers
May 14, 2019
- Kymriah Likely to Fetch 33 Million Yen Price Tag, Collategene to Skip Listing
May 14, 2019
- Xofluza, Opdivo, Keytruda, Bavencio under PMDA Risk Review
May 13, 2019
- Pituitary Dysfunction Added to Significant Adverse Reaction for Opdivo: MHLW
May 10, 2019
- MHLW Launches Survey on Authorized Generics to Get Data for Chuikyo Debate
May 8, 2019
- Next Public-Private Confab Set for May 20 before Full-Swing Pricing Debate
May 8, 2019
- Entyvio’s Crohn’s Disease Indication in Line for Approval in May
May 7, 2019
- Chuikyo Agrees to Require Genetic Info Submission for Insurance Coverage of Cancer Genomic Panel Tests
April 25, 2019
- PMDA to Set Up New Consultation Services for RWD Use in Regulatory Submissions
April 24, 2019
- MOF Pitches Higher Copay for Pricey Drugs Deemed Not Cost Effective
April 23, 2019
- Lilly’s EGFR Antagonist, Japan’s 1st Avastin Biosimilar Now in Line for June Approval
April 22, 2019
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Pharmaceutical sales per rep in Japan, a yardstick for “productivity” at drug makers, reached a record 172 million yen in FY2018, up 20 million yen from five years ago, as companies continue ramping up their job-shedding drive in a bid…
An adult man who completed the administration of an investigational drug in a Japan PI study conducted by Eisai has died. Whether there was a causal relationship between the drug and the subject’s death remains unclear at the present time,…
Riding on the back of an improved regulatory environment in China, major Japanese drug makers are moving to expand their businesses in the world’s second largest pharma market. Companies are pumping up their new drug pipelines, while forging solid sales…
Japan’s generic market is hitting a plateau soon. Incentive measures rolled out by the government since 2002 have driven its…
Some seven years in the making, Japan’s Ministry of Health, Labor and Welfare (MHLW) finally rolled out a cost-effectiveness assessment…
Japan will go ahead with the introduction of a cost-effectiveness assessment (CEA) scheme for drugs and medical devices in April…
Jascha Heifetz, widely regarded as one of the greatest violinists of all time, was once stopped, on 57th Street in Manhattan, by a pedestrian asking, “Could you tell me how to get to Carnegie Hall?” Heifetz pondered the question for…