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REGULATORY ICH Reaches Agreement to Treat Subjects with Similar Ethnic Factors as Single Populations Regardless of Nationality
December 18, 2015
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REGULATORY Survey Finds Unexpectedly Low Market Prices for Injectable Generics; Industry to Accept 50% Rule
December 17, 2015
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REGULATORY Chuikyo Subcommittee OKs Outline of FY2016 Drug Pricing Reform, Rollout of “Huge Seller” Re-Pricing
December 17, 2015
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BUSINESS LEO Pharma “Eager to Do More” after Astellas Deal to Expand Globally: CEO
December 16, 2015
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BUSINESS Mundipharma Poised to Expand Japan Operations by Tapping Isodine Brand: Asia Head
December 15, 2015
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ORGANIZATION PhRMA Sounds Alarm on “Huge Seller” Re-Pricing, Possible Decline in Japan Investment
December 14, 2015
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REGULATORY 6 Drug Makers to Participate in AMED’s Drug Discovery Consortium
December 11, 2015
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REGULATORY 3 Trade Groups Vehemently Oppose “Huge Seller” Drug Re-Pricing, Say It Will Hobble Innovation
December 10, 2015
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TRENDS “Huge Seller” Re-Pricing Targeting Hep C Drugs Will Dampen Innovative Market
December 9, 2015
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REGULATORY LDP Budget Debate in Homestretch; Govt Eyes “Huge Sellers”, Generics, Z2 to Squeak Out Funds for Upping Physician Fees
December 9, 2015
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REGULATORY PMDA to Begin Unannounced Regular Inspections in Wake of GMP Violations by Kaketsuken
December 8, 2015
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TRENDS Peak Sales Forecast for New Drugs Listed in 2015 Exceeded 840 Billion Yen with Big Contribution from Hep C Treatments
December 7, 2015
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BUSINESS Unusualness of Hep C Market Not Being Understood, Gilead COO Says on Possible Sovaldi Re-Pricing
December 4, 2015
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REGULATORY Probe Finds Kaketsuken’s GMP Violations “Extremely Malicious”, MHLW to Impose Penalty
December 3, 2015
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REGULATORY NHI-Market Price Gap at 8.8%, 6.8% Price Cut Expected in FY2016 Revision
December 3, 2015
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REGULATORY MHLW Discussing Use of Disease Registry as Substitute for Control Groups; Could Be “One Means of Evaluation” in Trials for Rare Diseases
December 2, 2015
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BUSINESS Mitsubishi Tanabe Set to Derive 40% of Sales Abroad in FY2020, Shed 1,200 Jobs over 5 Years
December 1, 2015
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BUSINESS Takeda, Teva Hook Up to Form Generic Joint Venture in Japan
November 30, 2015
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TRENDS AG Shares Reach 50-60% in 1 Year; Confidence in Quality Encourages Dominance Even without Market Lead
November 30, 2015
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REGULATORY Evaluation of Efficacy Was Challenging in Sakigake Pick, Designating All Qualified Drugs Desirable: MHLW Official
November 27, 2015
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I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
