RISFAX September 21, 2018
日本語- PMDA survey: Overwhelming portion of detailed safety information is “obtained from MR”
- Japan Pharmaceutical Manufacturers Association (JPMA) accepts amendments to the Transparency GL, to respond to Clinical Research Law
- Ministry of Health, Labor and Welfare (MHLW) panel: Consolidation of registry for conditional early approvals “can be done only by National Centers (NC)”
- JPMA president Nakayama: Personnel for intellectual property management at NC – “quality over quantity” in measures to address shortfalls in human resources
- Nippon Pharmacy Association (NPhA) survey: Deeply-rooted prescriptions “that cannot be changed” – Half of them become changeable through queries from pharmacists
- FKB and Mylan receive approval for “HUMIRA” biosimilar (BS) in Europe, to be launched after October
- Towa and TIS to establish joint venture to provide IT service to realize a society where regions co-exist
- Medipal to abolish Dispensing Strategy Department; Director Watanabe to concurrently serve as head of Systems
- Chugai Pharmaceutical wins HEMLIBRA suit in the U.S., with Baxalta having withdrawn the suit
- Astellas: Global Phase III study of “Roxadustat” achieves primary endpoints
- CSL Behring files for new formulation of “IDELVION”
- Fujisawa City Federation of Pharmacists strongly protests against sexual harassment issue of its ruling body, refuses to pay membership fee
- Suzuken: Maker distribution site “Iwaki Medical Terminal” to start operation in October
- Janssen launches anti-HIV drug “ODEFSEY Combination Tablets”