TOP STORIES

• ORGANIZATION 19 Companies Join JPMA Task Force on Quality Evaluation of Nucleic Acid Therapeutics
  September 18, 2018

• REGULATORY MHLW to Launch Mock Review Project to Up Standards of “Certified IRBs” under Clinical Research Law: Official
  September 14, 2018

• BUSINESS I/O in Lung Cancer - 5: Roche Looks Beyond Tecentriq, Laying Foundation for Next-Gen Immunotherapies
  September 13, 2018

• BUSINESS Nippon Shinyaku Eyes Conditional Early OK for Sakigake DMD Drug, Daiichi Sankyo Redoing PI/II for Its Antisense
  September 12, 2018

• REGULATORY Tailwind for Prevenar 13? Vaccine Panel Members Up for Its Use in High-Risk Elderly
  September 11, 2018

• BUSINESS Sanofi to Focus on Increasing Prescriptions of Lantus XR Based on Results of Head-to-Head Comparison Study
  September 10, 2018

• BUSINESS Giant Quake Disrupts Drug Production, Shipments in Hokkaido; Distributors Scramble to Ensure Supplies
  September 7, 2018

• BUSINESS Huahai Already Developed New Manufacturing Process for Valsartan API, Says Japan Chief after JMA Criticism on Impurity Issue
  September 6, 2018

• BUSINESS I/O in Lung Cancer - 4: Bristol-Myers Looks to Regain Ground for Opdivo with Immunotherapy Combos
  September 5, 2018

• TRENDS “Follow-On” Authorized Generics Gaining Ground in Matured Gx Markets; TS-1 Grabs 80% Share
  September 4, 2018

• REGULATORY FY2019 Revision Should Cover Only “Half a Year’s Worth” of Price Tweaks, MHLW Insurance Chief Says for Clarification
  September 3, 2018

• REGULATORY April 2019 Price Cut Wouldn’t Fit the Purpose of Tax Tweak: MHLW Insurance Chief
  August 31, 2018

• BUSINESS With Bullish Maviret, AbbVie Aims for Double-Digit Growth to Join Top 20 in 2018
  August 30, 2018

• BUSINESS Imfinzi, Gazyva Now Available in Japan
  August 30, 2018

• REGULATORY MHLW Discussing Use of Data from “Specified Clinical Research” in Application Dossiers, Will Issue Preliminary Conclusions by March
  August 29, 2018

• BUSINESS Gilead Japan Looks to End HIV Pacts with JT as It Seeks Long-Term Growth: Chief
  August 28, 2018

• BUSINESS Gilead, JT Start Talks on Terminating Japan HIV Pacts
  August 27, 2018

• REGULATORY Japan Eyes State Funds to Boost Sakigake Review Staffers: FY2019 Budget Request
  August 27, 2018

• REGULATORY MHLW to Expand MID-NET and Coordinate with Other Databases and Registries to Improve Safety Measures: Official
  August 27, 2018

• ORGANIZATION Regulatory Science Society Says “No” to Off-Label Info Supply by Drug Reps Conditionally OK’ed in Draft MHLW GLs
  August 24, 2018

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