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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- LDP Lawmakers Irked as Govt Stands Fast on Off-Year Re-Pricing/Survey Plan; Honebuto Text Tweak Unclear
July 10, 2020
- MHLW’s OTC Panel Begins Discussions toward Interim Report; to Seek Solutions for Problems in Switch-OTC Approval
July 10, 2020
- Original Plan Remains Unchanged for Off-Year Drug Re-Pricing, Survey: Minister
July 9, 2020
- AnGes’ COVID-19 Vaccine Given Some Safety Confirmation Before Clinical Trial: MHLW Official
July 9, 2020
- LDP Lawmakers’ League to Launch Group to Protect People against HPV
July 8, 2020
- MHLW Set to Approve Label Expansions for Kadcyla, Keytruda, Imfinzi and More
July 7, 2020
- Japan Govt Likely to Stick to 2020 Off-Year Drug Re-Pricing Plan in Honebuto Paper
July 6, 2020
- Create Cross-Bureau Scheme at MHLW to Fuel Rx-to-OTC Switches: Regulatory Reform Panel
July 6, 2020
- MHLW Donates Nearly 200 Million Yen to GARDP to Combat Antimicrobial Resistance
July 6, 2020
- Key MOF Panel Passes on Typical Budget Recommendation amid COVID-19
July 3, 2020
- Ruling Parties Call for Careful Discussions on Off-Year Drug Re-Pricing
July 3, 2020
- MHLW to Report Approval Plan for Otsuka Pharmaceutical Factory’s Infusion Solution on July 15
July 3, 2020
- LDP Generic Study Group Urges Govt to Restructure Drug Supply Chain
July 1, 2020
- LDP Study Group Calls for Budgets to Accelerate Genome Analysis Project
July 1, 2020
- Specific Vaccine Negotiations with AstraZeneca about to Start: Minister
July 1, 2020
- Japan Approval for MSD’s 9-Valent HPV Vaccine Delayed into July
June 30, 2020
- Japan Approves Entresto, 4 Other Novartis Meds, Rybelsus, 1st Humira Biosimilar and More
June 30, 2020
- 418 Key Drug Candidates Listed by 36 Societies, Panel to Outline Stable Supply Measures at Next Meeting
June 29, 2020
- PMDA Reviewing Safety Risk for 10 Contrast Agents
June 29, 2020
- LDP’s Coronavirus Task Force Calls for Caution in Off-Year Re-Pricing Debate
June 26, 2020
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