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REGULATORY
- ICH Eyes Major GCP Revamp with Use of Real World Data: Osaka Confab
November 16, 2016
- 3 Immunosuppressants to Be Discussed for Lifting of Contraindicated Pregnancy Use
November 16, 2016
- Opdivo’s NHI Price-Based Sales Put at Over 151 Billion Yen; 50% Cut Likely to Take Effect Feb. 1
November 15, 2016
- MHLW Advisory Committee to Review Biogen’s MS Drug on Nov. 25
November 14, 2016
- Opdivo Gets MHLW Panel Nod for Hodgkin’s Lymphoma
November 14, 2016
- MHLW Panel to Discuss NSCLC Indication for Keytruda on Nov. 24
November 14, 2016
- LDP Study Group on Biologics to Hold 1st Meeting on Nov. 24; Aims to Halt the Rush to Promote Biosimilars
November 11, 2016
- Chuikyo Members Chide Unexplained Withdrawal of Taltz’s Listing Request
November 10, 2016
- MHLW Won’t Require Use of Other Psoriasis Drugs before Taltz
November 10, 2016
- MHLW Plans 50% Price Cut for Opdivo
November 10, 2016
- Chuikyo OKs Taltz, Micatrio for Listing on Nov. 18; Keytruda Takes Pass This Time
November 9, 2016
- LDP Lawmakers Discuss Re-Pricing of Opdivo; Some Say Application of Huge Seller Rule Reasonable
November 9, 2016
- Shiozaki Lauds BIKEN-Mitsubishi Vaccine JV
November 8, 2016
- PMDA Fastest in Granting New Drug Approvals
November 4, 2016
- PMDA Mulls Fee Raise for Drug, Device Reviews
November 4, 2016
- Medical Corporation in Tokyo Ordered to Temporarily Suspend Regenerative Medicine Service: MHLW
November 4, 2016
- MHLW Struggling to Set Date for Chuikyo Subcommittee Discussions on Opdivo
November 2, 2016
- MHLW Panel Backs Ono’s Hyperparathyroidism Drug Etelcalcetide
November 1, 2016
- PMDA Had 71 Individual Interviews in Regulatory Strategy Consultation Services in April-September 2016
November 1, 2016
- Inisync, 4 Other DPP-4 Inhibitors Under PMDA Risk Review
October 31, 2016
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A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
