While Japan has now granted its first emergency approval to Shionogi’s COVID-19 pill Xocova (ensitrelvir), the drug failed to win a unanimous vote by advisory panels, with skepticism lingering over its actual efficacy. To prep for the next emergency, which…
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TOP STORIES
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REGULATORY Notification Calls for Simultaneous Filing of Applications for Companion Diagnostics and Drugs
July 3, 2013
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BUSINESS Japanese Society of Chemotherapy Joins Hands with Pharmas, Govt to Spur New Antibiotic Development
July 2, 2013
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ORGANIZATION JMA Sets Up Pharmaceutical Affairs Section
July 1, 2013
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BUSINESS Bayer Yakuhin to Shift Resources to Innovative New Drugs: President Brunn
June 28, 2013
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ACADEMIA NHO Attains 30% Volume-Based Generic Target in FY2012
June 28, 2013
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REGULATORY MHLW Maps Out New Vision for Pharma Industry; Research-Based Makers Will See “Survival of the Fittest,” It Says
June 27, 2013
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BUSINESS Eisai to Suspend Sales of Future Mainstay Antiepileptic Drug in Germany
June 26, 2013
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BUSINESS Filgrastim Biosimilars: Overseas Track Record vs. “Purely Made-in-Japan” Label
June 25, 2013
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ACADEMIA Makers Should Venture into Drug Development Using iPS, CiRA Adviser Asonuma Says
June 25, 2013
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REGULATORY FPMAJ May Find it Difficult to Compile Unified Statement of Views on TPP Talks Due to Disagreement among Original and Generic Drug Makers
June 24, 2013
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ORGANIZATION JGA Concerned about TPP Talks, Hopes Japan Will Adopt US Rules Favorable to Generic Makers
June 24, 2013
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ORGANIZATION JPMA Weighs Scheme to Allow Use of Clinical Research Evidence for Drug Applications
June 21, 2013
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BUSINESS Anatomy of Mutual Reliance - Diovan Papers and Company Part 2: Explanations to the World Urged
June 21, 2013
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REGULATORY MHLW to Resume Inviting Requests for Development of Unapproved Drugs, Indications; No Deadline Set This Time
June 20, 2013
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BUSINESS Anatomy of Mutual Reliance - Diovan Papers and Company Part 1: A Blurred Line
June 20, 2013
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BUSINESS Novartis Pharma to Voluntarily Refrain from Participation in JPMA’s Board of Directors Meeting
June 19, 2013
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REGULATORY MHLW to Temporarily Withdraw Recommendation of Preventive Cervical Cancer Vaccinations
June 18, 2013
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REGULATORY Cabinet Approves PM Abe’s Growth Strategy, Regulatory Reform Plan
June 17, 2013
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BUSINESS ARBs Still Best Sellers in FY2012 Sales Ranking, Januvia Ranks in Top 10 after only 3 Years of Launch
June 14, 2013
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REGULATORY CSIMC’s Expert Subcommittee on NHI Drug Pricing Affairs to Hold Hearings for Drug Pricing Organization at Next Meeting in July
June 14, 2013
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