Japan introduced a new health coverage scheme for long-listed products (LLPs) on October 1. A survey of generic drug makers…
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COMMENTARY
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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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Final Preparations Underway for Trial Run of Medical Database
September 25, 2012
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Competition Getting Fiercer in COPD Drug Market
September 13, 2012
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FY2013 Budget Expected to Have Positive Impact on Pharmaceutical and Medical Device Industries
August 30, 2012
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Pharmaceutical Bar Coding Initiatives Spreading Among Western Countries
August 21, 2012
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A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…
The Japanese health ministry on December 22 approved a batch of medicines for additional indications, including Otsuka Pharmaceutical’s atypical antipsychotic Rexulti (brexpiprazole) and Zenyaku Kogyo’s anti-CD20 antibody Rituxan (rituximab).Rexulti is now newly indicated for the treatment of depression and depressive…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…
A key Japanese reimbursement policy panel on December 16 approved the government-backed plan for the FY2023 “off-year” drug price revision.…
Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…
Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…