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REGULATORY
- G-CSF Preparations Ordered to Add Anaphylaxis in ADR List
September 14, 2016
- Blue Book “Will Be Used as Reference When Selecting Generics”: Panel Chair
September 14, 2016
- PMDA, FDA, EMA Agree on 6 Regulatory Approaches on AMR
September 13, 2016
- G7 Health Ministers Adopt Kobe Communique
September 13, 2016
- Generics from 5 Companies Enough When Major Products Lose Patent Protection: Top Bureaucrat
September 13, 2016
- Kaketsuken “Should Seriously Reflect” on Its Conduct before Asking for Permission to Continue Business: Health Minister
September 12, 2016
- MHLW Panel Backs Approval of Pembrolizumab, Some Voice Concerns for Its High NHI Price
September 12, 2016
- MHLW Panel OKs Humira for Uveitis
September 12, 2016
- Kaketsuken’s Business Transfer Necessary: MHLW Official
September 9, 2016
- MHLW Reports Partial Modifications of Approval for 3 Drugs Including Polidocasklerol to Advisory Panel
September 9, 2016
- MHLW Panel Backs BI’s Triple Combo After 3rd Try
September 9, 2016
- NIBIOHN Strengthens Collaboration with Drug Makers to Promote Development of Japan-Originated Drugs
September 8, 2016
- MHLW Re-Stresses Caution over Use of EGFR TKIs in Opdivo-Treated Patients
September 7, 2016
- Barcode Labeling Increasing in Anticipation of Mandatory Use in 2021: MHLW Survey
September 6, 2016
- 6 National Centers Log Generic Use Rate of Average 73.8% in FY2015
September 6, 2016
- MHLW Issues Notification on Partial Revision of Rules for New Barcode Labeling to Be Required from April 2021
September 6, 2016
- PMDA to Host Int’l Seminars in 2017 under Asian Training Center Initiative
September 5, 2016
- G7 Health Ministers to Discuss AMR Measures at Upcoming Kobe Confab
September 5, 2016
- METI Seeks 7.2 Bil. Yen for Drug Discovery, 3.5 Bil. for Regenerative Medicine
September 2, 2016
- Panel OKs Iridosteresis, 7 Other Illnesses as Designated Intractable Diseases
September 1, 2016
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We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
