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REGULATORY

MHLW Guidelines to Call for Thorough Internal Communications at Pharmas after Novartis’ Delayed ADR Reporting

The Ministry of Health, Labor and Welfare (MHLW) will urge drug makers to establish a strong internal communication system via its guidelines to be issued ahead of the enforcement of ... > Read full story
BUSINESS
Bristol-Myers Submits NDA for Malignant Melanoma Drug Ipilimumab (Sep.22)
ORGANIZATION
JPMA to Unify Method of Disclosing Sensitive Payment Information from Next Year (Sep.22)
BUSINESS
Additional Indication Approved for MTPC’s Telavic (Sep.22)
BUSINESS
RaQualia Wins Use-Patent Allowance for EP4 Antagonist in US (Sep.22)
BUSINESS
Bayer’s Japan Open Innovation Center Now Up and Running (Sep.22)
> More Latest News

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MHLW Official Concerned about Generic Codevelopment, but Denies Plans to Press for Industry Consolidation (Sep.19)MTPC Generic Arm Seeks to Quickly Broaden Product Lineup, New Alliance a Possibility: Pres. (Sep.18)Nippon Shinyaku to Gear Up R&D, Commercialization of Nucleic Acid Products (Sep.17)
  
Regulatory Reform Council to Monitor Progress on Proposed Pricing Overhaul of Innovative Drugs (Sep.17)Sanofi Taps Call Center to Prevent Patient Dropouts from Insulin Therapy (Sep.16)Takara Bio Pushes for Melanoma Drug Development with Eye on Fast Approval (Sep.12)

News Categories

REGULATORY
   MHLW Guidelines to Call for Thorough Internal Communications at Pharmas after Novartis’ Delayed ADR Reporting(Sep.19)
   MHLW Official Concerned about Generic Codevelopment, but Denies Plans to Press for Industry Consolidation(Sep.19)
   Selexipag, 4 Other APIs Designated as Orphan Drugs(Sep.19)
BUSINESS
   Bristol-Myers Submits NDA for Malignant Melanoma Drug Ipilimumab(Sep.22)
   Additional Indication Approved for MTPC’s Telavic(Sep.22)
   RaQualia Wins Use-Patent Allowance for EP4 Antagonist in US(Sep.22)
ORGANIZATION
   JPMA to Unify Method of Disclosing Sensitive Payment Information from Next Year(Sep.22)
   JPMA to Suspend Hasegawa’s Veep Activities for Another 6 Months over CASE-J(Sep.19)
   CDISC CEO Advises Drug Makers to Collect Data Based on CDASH(Aug.27)
ACADEMIA
   Dr Yui Poses Questions on Dabigatran Analysis Model on BMJ(Sep.09)
   Prof. Komuro to Issue Objection to Chiba University in Wake of Second Retraction Request Related to VART Study(Sep.09)
   Kyoto University, Astellas Aim to Develop Immunological Disease Cures, 11 Target Molecules Now under Screening(Aug.21)

Commentary

Picture of Future Regulations on Investigator-Led Clinical Research Emerging

Lexicon

Drug requiring guidance:
要指導医薬品

The Column

Is Your Body Language Louder than Your Speech?

Archives

Sadao Furuichi to Double as Heads of Kracie Pharma, Kracie Pharmaceutical(Sep.22)
JPMA to Suspend Hasegawa’s Veep Activities for Another 6 Months over CASE-J(Sep.19)
MHLW Official Concerned about Generic Codevelopment, but Denies Plans to Press for Industry Consolidation(Sep.19)
Huya Bioscience International Opens Tokyo Office(Sep.19)
Selexipag, 4 Other APIs Designated as Orphan Drugs(Sep.19)

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