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REGULATORY
- Novo’s Ozempic Skips Listing for 3rd Time 8 Months after Approval
November 14, 2018
- Chuikyo OKs Listing of Astellas’ AML Med, Lilly’s Verzenio and More on Nov. 20
November 14, 2018
- Maviret Faces 25% Price Slash in Quarterly Review
November 14, 2018
- Despite Being 4th in ALK Class, Lorbrena Qualifies for PMP as It Gets 5% Pricing Premium
November 14, 2018
- New Health Minister Stresses Need for Drug Discovery Support at His 1st Confab with Industry
November 13, 2018
- Novartis’ SMA Gene Therapy Filed in Japan on Nov. 1 after US, EU; What Will Happen to Sakigake Status?
November 13, 2018
- MHLW Panel OKs Otsuka’s Alcohol Dependency Drug
November 12, 2018
- Panel Approves Health Ministry’s Proposal to Provide Package Insert Information in Electronic Form
November 12, 2018
- ViiV’s HIV Med Juluca Clears MHLW Panel for Quick Approval
November 12, 2018
- E19, M10 Guidelines Expected to Reach Step 2 at Upcoming ICH Meeting in US
November 9, 2018
- Nipro’s Sakigake-Designated Spinal Cord Injury Stem Cell Treatment Up for Approval Review on Nov. 21: MHLW
November 9, 2018
- LDP Conducts Hearing with Pharma Trade Groups for FY2019 Budgets, Tax Reform
November 9, 2018
- LDP Health Bigwigs Agree to Push for October 2019 Revision
November 9, 2018
- Experts Say ICER Deduction Unscientific, MHLW Proposes Different Thresholds for Cancer and Orphan Drugs
November 8, 2018
- Chuikyo Supports Price Raise Rules for Cost-Effective Products
November 8, 2018
- MHLW Pitches “Tiered Model” for CEA Price Tweak, but Faces Chuikyo Opposition
November 8, 2018
- FY2019 Tax Reform Debate Going into Full Swing; Will Pharma Industry Win Expansion in R&D Credit?
November 7, 2018
- Freeze-Dried BCG Vaccine Shipment Suspended due to Arsenic in Diluent; MHLW Panel Calls for Switch to New Product
November 7, 2018
- MHLW Sets Carcinogen Limits in ARBs after Valsartan Impurity Issue
November 6, 2018
- AMED Study Group to Draft Guidelines to Promote Expanded Indications for Neuropathic Pain Drugs
November 6, 2018
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