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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- Final Report from Govt’s All-Generation Social Security Council to Be Delayed until Year-End
May 26, 2020
- Japan Govt to Give Up on May-End Goal for Avigan Approval
May 26, 2020
- June Approval Likely for Entresto as It Clears Key Panel; HFpEF Use OK’ed Too
May 25, 2020
- Panel OKs Ofev for PF-ILD; Label Expansion for Xtandi/Erleada, Prevenar and More
May 25, 2020
- MSD’s 9-Valent HPV Vaccine Now in Line for June Approval; Eyes on Its Possible Inclusion in National Immunization Program
May 25, 2020
- PMDA Reviewing Safety Risks for Avastin, Memary
May 25, 2020
- AMED to Fund 4 Company-Led COVID-19 Vaccine Development Projects
May 25, 2020
- Avigan Not Yet Filed in Japan, but Govt Still Seeks Approval by Month-End: Kato
May 25, 2020
- Add MSD’s 9-Valent HPV Vaccine to National Immunization Program If Approved: Lawmakers
May 21, 2020
- Label Revisions Ordered for 15 Insulins, Erleada, Faslodex
May 20, 2020
- MHLW Adds Veklury in Updated COVID-19 Treatment Guide
May 20, 2020
- LDP Lawmakers Call for Environment to Facilitate Vaccine Development
May 20, 2020
- MOF Delays FY2021 Budget Request Deadline, Honebuto amid Coronavirus Woes
May 20, 2020
- Check Latest Info and Make Careful Decision on Veklury Use: PMDA Review Report
May 19, 2020
- MHLW Panel to Discuss HIF-PH Inhibitors from GSK, Mitsubishi Tanabe on May 29
May 19, 2020
- MHLW Panel to Discuss Orphan Status for 5 Cell and Gene Products
May 19, 2020
- Health Ministers of Japan, China, South Korea Commit to Support WHO on COVID-19, Timely Share Info
May 19, 2020
- Govt Won't Require Fujifilm-Sponsored Trial Data to Approve Avigan for COVID-19: Abe
May 18, 2020
- Novartis’ Tabrecta, Enerzair Up for MHLW Panel Review on May 28
May 15, 2020
- Japan’s First Humira Biosimilar Could Hit Market as Early as November
May 15, 2020
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