As 2019 rolls in, we expect to see a flurry of approvals in the Japanese regenerative medicine arena, with regulatory decisions anticipated by the end of the year for Novartis Pharma’s CAR-T therapy and many more products, which could bring…
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- MHLW Panel Recommends Conditional Approval for Nipro’s Stem Cell Product for Spinal Cord Injury
November 26, 2018
- MHLW Eyes Drastic Change to Cost Effective Analysis Flow, Enhanced Discussions Upfront
November 22, 2018
- MHLW Proposes Quarterly Product Selections, Price Tweaks for CEA Scheme: Chuikyo
November 22, 2018
- MOF Panel Urges Govt to Use Economic Evaluations for Reimbursement Decisions: FY2019 Budget Recommendation
November 21, 2018
- Amgen Astellas’s Osteoporosis Med Romosozumab Up for MHLW Panel Review on Dec. 3
November 20, 2018
- Keytruda’s MSI-H Cancer Use Up for MHLW Panel Review Nov. 29; Wider Hemlibra Indication, 1st Line Tecentriq Also on Agenda
November 16, 2018
- Chuikyo Agrees on October 2019 Drug Price Revision for Tax Hike, but Final Call Is Up to Govt
November 15, 2018
- MHLW Revises Imfinzi’s Optimal Use Guidelines for NSCLC, Calling for PD-L1 Expression Test
November 15, 2018
- 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
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