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REGULATORY
- MHLW Alerts on αβ T-Cell Therapy after Opdivo
July 29, 2016
- MHLW Official Positive about Seeking Budgets to Boost PMDA Reviewers
July 29, 2016
- Pricy Meds Issue Takes a Step Forward with 2-Faceted Proposal
July 29, 2016
- Chuikyo OKs Plan to Compile “Optimal Use Guidelines,” Beginning with Opdivo, Repatha
July 28, 2016
- Chuikyo to Discuss Out-of-Cycle Re-Pricing for Opdivo, but JMA Turns Wary
July 28, 2016
- MHLW to Work with PMDA from an Early Stage to Build Clinical Innovation Network: Division Head
July 28, 2016
- MHLW to Canvass Drug Makers’ Opinions on Real-World Roles of “3 Key Officers”: Pharma Safety Head
July 27, 2016
- Expert Taskforce Roughly OKs Report on Genomic Medicine
July 26, 2016
- ICH Clinical Trial Guidelines Allow Flexibility on Number of Japanese Subjects Needed: PMDA Official
July 26, 2016
- Revised GCP Ordinances Open Ways for Compassionate Use of Medical Devices, Regenerative Medicines
July 25, 2016
- MHLW Panel to Review ASKA’s Hepatic Encephalopathy Drug, Opdivo’s RCC Indication on Aug. 5
July 25, 2016
- Intractable Neurological, Psychiatric Diseases Initially Eyed for PMDA-NCNP Drug Development Guidelines
July 25, 2016
- MHLW Alerts on Use of EGFR TKIs in Opdivo-Treated Patients after 3 Deaths
July 25, 2016
- MRSA Infections Add 190 Billion Yen Annually to Medical Expenditure at DPC Hospitals: MHLW Study Group
July 25, 2016
- MHLW Advisory Panel to Discuss Novartis’s Acromegaly Drug on August 4
July 22, 2016
- MHLW Panel OKs Basic Policies for Next JP Edition, Due Out 2021
July 21, 2016
- ICH Guidelines on Multi-Regional Clinical Trials Up for Public Comments: MHLW
July 21, 2016
- Ono Issues Red Flag over Use of Immunotherapies Together with Opdivo
July 21, 2016
- PMDA to Announce Evaluation Policy on Diagnosis Using Next-Generation Sequencers
July 21, 2016
- PMDA Working Group to “Feed Back Experiences in Reviews” toward Creation of Clinical Innovation Network
July 20, 2016
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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…
