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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- PMDA Sets Target Review Times for Partial Changes to Generic Approval - A New Way to Underpin Stable Supply
August 4, 2014
- Competition Fuels Personalized Medicine Market, First-Line Positions Eyed for Xalkori, Alecensa
July 28, 2014
- Can New Fast-Track Review System Perk Up Drug Makers’ Development Drive in Japan?
July 7, 2014
- June Reimbursement Listing Could Mark Watershed in Japan Generic Market
July 1, 2014
- Two Reasons MHLW Opposes Yearly NHI Price Revisions, “Annual” Dropped from Gov’t Policy Guidelines
June 17, 2014
- Delicate Balancing Act Required for SGLT-2 Inhibitor Promotions - Safety vs Efficacy
June 16, 2014
- Why Not Make RMPs for Existing Products as Differentiation Strategy?
June 9, 2014
- 2013 Earnings Signal Foreign Drug Makers Losing Steam in Japan
June 2, 2014
- Clinical Research Regulations at Crossroads: Guidelines or Legislation?
May 26, 2014
- Was the Main Paper from VART Study “Practice” for a Grad Student?
May 19, 2014
- Can CROs Become Independent Players? Compliance, Ethics Will Be Major Issues for Growing Industry
April 28, 2014
- Industry Faces Tough Road to Institutionalization of Key Premium, Eligibility Up for Discussion
April 21, 2014
- Approval of Novel Antiepileptic Drugs as Monotherapies Coming Closer to Reality
April 7, 2014
- Will Japan NIH Initiative Create a “Japanese Model” that Overcomes Its Size Disadvantage?
March 28, 2014
- CASE-J Flutter: Doesn’t Blopress Ad Overemphasize Its Benefits on Diabetes?
March 19, 2014
- “Lack of Urgency” Leads to New Rule; Penalty for Low Price Settlement Rates May Have Been Inevitable
March 12, 2014
- Hardships and Successes of Diversified Entrants Lead to Question: Will Pharmaceuticals Continue to Be a Growth Sector?
March 5, 2014
- Revised JCS Guidelines Clarify Role of Novel Oral Anticoagulants in Patients with Atrial Fibrillation
February 12, 2014
- Will JPWA’s Move to Integrate Tax Display Method Dispel Medical Institutions’ Misconception?
January 31, 2014
- FY2014 May Be Year 1 of New Reform Era; Drug Makers Need to “Turn Calamity into Good Fortune”
January 7, 2014
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