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REGULATORY
- Shiozaki Hints at Delay in MHLW Report on Vaccines and Blood Product Policies
March 24, 2016
- Ethical Hurdles for Placebo-Controlled Studies Could Be Cleared with Certain Designs: PMDA Panel
March 23, 2016
- MHLW Alerts on Risk of Respiratory Depression for Flunitrazepam Injectables, Orders Label Revision
March 23, 2016
- PMDA Chief Kondo Reappointed for 5th Term
March 23, 2016
- Drug Makers Should Ponder Their Role in Community-Based Integrated Care System: MHLW Official
March 22, 2016
- MHLW OKs Cymbalta’s New Pain Indication, Raises Caution on Its Use
March 22, 2016
- New Basic Guidelines for Hepatitis Measures to Push IFN-Free Therapies, Hep B Vaccines
March 18, 2016
- MHLW Official Asks Industry to Discuss Candidates for Essential Medicines
March 18, 2016
- Kamoya Prods Regulatory Science Society to Compile Essential Drug List
March 17, 2016
- Whether to Draw Line between 15 Billion and 100 Billion Yen Sales Thresholds for Re-Pricing Will Hold Key: Kamoya, Nakai
March 17, 2016
- Coefficient for New Generic Pricing “Will Decline Further” if Business Practices Are Not Changed: JGA Official
March 17, 2016
- Opdivo Gets Orphan Status for Hodgkin’s Lymphoma
March 17, 2016
- Nobelpharma CEO Says Sakigake System “Very Helpful”
March 17, 2016
- PMDA Had 43 Advanced Regulatory Advisory Sessions with Startups, Academia in FY2015
March 16, 2016
- Vaccine Panel Wary about Including Synflorix in Public Immunization Program
March 16, 2016
- Oculomucocutaneous Syndrome, Erythema Multiforme Added to ADR List for Halaven
March 16, 2016
- MHLW to Require CTD-Based Submissions for Generics, Effective March 2017
March 15, 2016
- Sales Thresholds for Re-Pricing Rule to Be Key Point of Future Discussions: MHLW Pharma Management Director
March 15, 2016
- MHLW Panel Launches Discussions on New Basic Plan against Cancer
March 14, 2016
- MHLW Panel Roughly OKs Use of MID-NET Database by Drug Makers
March 14, 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…
