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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COMMENTARY
- Will New Drug Makers Dominate Domestic Biosimilars Market?
December 26, 2011
- Pressure Mounting for Additional NHI Price Cut for Long-listed Drugs
December 12, 2011
- “Drug Discovery Support Organization” Faces Doubts: Can It Pick Winners?
November 28, 2011
- Perpetuation of Premium for New Drug Development Faces Hurdles
November 14, 2011
- Further Research Needed to Advance the Use of Regulatory Science in Regulatory Affairs
November 14, 2011
- Impact on Japanese Pharmaceutical Companies Unavoidable: TPP Negotiations
October 19, 2011
- Pinning Hope on Academia in Seeking a Radical Cure for AD
October 10, 2011
- New Ideas Needed to Address “Insurance Lag” for GE Drug Makers That Submit Applications Based on Info. in Public Domain
October 3, 2011
- Discussions on Amendment of PAL Now in Final Stages
October 3, 2011
- Korosho Revises GL for Drafting, Distributing Drug Safety Information
September 5, 2011
- Final Decision on Avastin's Indication for Breast Cancer Must Satisfy the Public
August 29, 2011
- Why Eisai's Novel Anticancer Agent Halaven Received the Highest Ever Operating Profit Rate
August 8, 2011
- Current Promising Drug Candidates with a New Mode of Action
August 8, 2011
- Consumption Tax Hike to Go With Measures to Increase Efficiency of Soc. Security System
July 18, 2011
- Actos Bladder Cancer Risk Highlights Problems with Safety Measures in Japan
July 4, 2011
- Era of Competition Dawns in Market for AD Treatments
June 27, 2011
- Will Dialogue between PSJ, JAMS Accelerate Development of Switch OTC Drugs?
June 20, 2011
- Return to Full-bore Growth Strategy Risky for Taiyo Pharm
June 13, 2011
- Why the Same Mistake Repeated? -MSD's Promotion Code Violations
June 6, 2011
- GE Makers to Make Difficult Decision on Actos Generics due to Combination Patent
June 6, 2011
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