Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
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- Revised PAL to Embrace “Deeper” Safety Measures, Yet Also Escape Clauses to Ease Company Burdens
September 29, 2014
- Series of CRPC Drugs Make Japan Debut, Expanded Indications Key to Success
September 24, 2014
- Picture of Future Regulations on Investigator-Led Clinical Research Emerging
September 9, 2014
- With No Pilot at Helm, Pharma Industry Embroiled in Confusion with Voluntary Funding Disclosures
September 1, 2014
- Wholesalers’ Q1 Earnings Remain Positive, Medical Fee Cut Rule Seen to Boost Accuracy of Financial Results in Sept.
August 25, 2014
- Japanese Drug Makers Working to Increase Pace of Drug Discovery by Optimizing Operations at Research Centers
August 18, 2014
- 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
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As Japan approaches the Fiscal System Council’s “autumn recommendation,” a notable shift is taking shape. The Ministry of Finance (MOF),…
Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…