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
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Bearing “Edo” in Its Name, Japan-Originated Edoxaban Set to Challenge Rival Anticoagulants in World Market
December 6, 2013
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MHLW Shocks Generic Drug Industry by Proposing “50% Rule,” Expansion of Uniform Pricing
November 19, 2013
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Range of Drugs Eligible for Premium for New Drug Development May Be Reviewed; Industry Needs to Dispel Suspicions
November 13, 2013
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Interim Report of Diovan Committee Raises Further Questions
October 15, 2013
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Remicade Biosimilar Debut Awaited in FY2014; Good Opportunity to Revisit Healthcare Finance?
October 4, 2013
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Comprehensive Review of Package Inserts to Begin with Effort to Identify Inconsistencies Between Inserts for Similar Drugs
August 27, 2013
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Transparency Guidelines Go Live, Will It Help Pharmas Win Public Trust?
August 2, 2013
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Overseas Outlook Will Be Essential to Survival and Progress of Domestic CROs
June 24, 2013
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PMDA’s Seriousness About Becoming a Leading Global Regulatory Authority to Be Tested
May 30, 2013
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Beyond Risk Management: RMPs Provide Opportunity for Post-Marketing Drug Development and Product Differentiation
May 8, 2013
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Iressa Cases Signal Risks Hiding in Daily Clinical Practices
April 22, 2013
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Will Drugs that Fight Cancer Stem Cells Succeed? Domestic Clinical Trial by DSP on the Horizon
March 15, 2013
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Gov’t, Industry to Support Developing Countries through Development of Drugs for Infectious Diseases; Hoping to Secure Future Business Opportunities as Well
February 27, 2013
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What Next for a “Mature” ICH? What More Can Be Done Beyond Regulatory Harmonization?
January 22, 2013
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Hot Products in 2013: New Drugs Likely to Jolt RA Treatment, Anticoagulant Markets
January 8, 2013
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Counterfeit Drugs: Risks Lurking in Globalization
December 28, 2012
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Can Japan Craft Its Own “Compassionate Use” System without Spoiling Drug Makers’ Development Drives?
December 7, 2012
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Recent Announcements of Suspended Product Supplies Highlight Supply Risks Faced by Generic Drug Industry
November 27, 2012
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Will Integration of Domestic Makers Be Enough for Sustainable Plasma Fractionation Operations?
November 16, 2012
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Approval of Switch-OTC Epadel Puts Spotlight on Quality, Track Record of Pharmacists
November 9, 2012
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