The delayed approval and price setting of Novartis Pharma’s Zolgensma (onasemnogene abeparvovec), a gene therapy for spinal muscular atrophy (SMA) listed in May, has raised questions about how the sakigake designation system should be operated. Despite being designated for the…
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- AMED to Fund 29 New Research Projects to Develop COVID-19 Treatments, including 5 Company-Led Projects
June 24, 2020
- MHLW Grants Orphan Status to Venetoclax, 5 Other APIs
June 24, 2020
- MHLW to Hasten Electronic Scrip Rollout to Summer 2022: Health Minister
June 23, 2020
- Japan Likely to OK CureApp’s Smoking Cessation App in July
June 23, 2020
- Sakigake Status Awarded to GSK’s Next-Gen I/O Therapy, 2 More Drugs; System Possibly Subject to Review Next Time
June 22, 2020
- MHLW Council Determines High Medical Needs for 2 Antiemetics
June 22, 2020
- MHLW Delays Chuikyo Discussion Timeline for Off-Year Price Survey, Drops June-End Goal
June 22, 2020
- LDP Pharma Study Group Submits Proposal, Says Off-Year Re-Pricing Should Be Delayed
June 19, 2020
- First Generics for 18 APIs Join NHI Price List; Patent Row-Hit Edirol Gx, 7 AGs Included
June 19, 2020
- AnGes Coronavirus Vaccine Trial to Start on June 30: Osaka Mayor
June 18, 2020
- Chuikyo Doctor Reps Nix Drug Price Survey Discussion, Say It Should Only Come after Govt’s Go/No-Go Decision
June 18, 2020
- MHLW Plans to Introduce Scheme to Scrutinize Generic Makers’ Stable Supply Ability, Beginning with December Listing
June 18, 2020
- Orphan Status for Otsuka’s Sakigake-Designated Product, and 4 Other Cell and Gene Therapies Endorsed
June 18, 2020
- 0.1% of Tokyo Residents Test Positive for Coronavirus Antibodies: MHLW
June 17, 2020
- Label Revisions Ordered for Avastin, Memary
June 17, 2020
- Japan Stiffens Foreign Investment Rules for Certain Drug, Medical Device Manufacturers
June 16, 2020
- MHLW to Propose Two-Third Sampling Rate for Wholesaler Survey for Off-Year Drug Re-Pricing; Go/No-Go Debate to Continue
June 16, 2020
- MHLW Starts Inviting Coronavirus Vaccine Developers after 2nd Extra Budget Passed
June 15, 2020
- Japan Panel OKs World’s 1st iPSC-Based Transplant for Retinitis Pigmentosa
June 12, 2020
- MHLW to Allow Blood Collection for Use of Blood in Drug R&D under Amended Blood Law
June 12, 2020
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