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REGULATORY
- Japan’s 1st Herceptin Biosimilar Clears MHLW Panel, Now in Line for March Approval for Gastric Cancer
February 5, 2018
- MHLW Panel Backs “Sakigake” Influenza Drug; Possibility of Accelerated Approval and Listing Unclear
February 5, 2018
- MHLW Cautions on Hepatitis E Virus Infection due to Blood Products for Transfusion
February 2, 2018
- MHLW Panel Calls for Single-Product, Single-Price Transactions for Blood Products
February 2, 2018
- Proper Use of Ethical Moisturizing Agents Added to Supplementary Opinion for FY2018 Reimbursement Reform: Chuikyo
February 1, 2018
- Drug Pricing Reform Draws Mixed Opinions: Public Comments
February 1, 2018
- Drug Makers Looking to Adopt Continuous Manufacturing, Anticipating 30-40% Lower Production Costs: PMDA Official
January 31, 2018
- MHLW to Create Framework for Announcing Results of Clinical Research in Tandem with Enforcement of Clinical Research Law
January 29, 2018
- Chuikyo to Continue Discussions on Drug Pricing Reform “After Verifying Impact on Stakeholders”; Further Discussions on Essential Drugs
January 29, 2018
- Chuikyo Discusses Hirudoid, Gx at 2nd Review Round for FY2018 Fee Schedule Revision
January 29, 2018
- MHLW Panel Backs Novo’s Semaglutide after Recommendation Hold
January 29, 2018
- MHLW’s Drug Distribution Guidelines Issued for Enforcement in April
January 26, 2018
- MHLW Reiterates Caution over Tagrisso Use after Opdivo Treatment
January 26, 2018
- IPRP to Hold First Meeting in June in Japan, May Take up Harmonization of Regulations on Regenerative Medicine Products
January 26, 2018
- Chuikyo Enters Final Review of FY2018 Fee Schedule Revision; Recommendation Due Out Feb. 7
January 25, 2018
- MHLW to Launch New Project to Strengthen Generic Drug Use in Around 10 “Priority Prefectures” Aiming at 80% Volume Share Target
January 25, 2018
- Japan Govt to Halt R&D Tax Break for Small Spender Companies: PM Abe
January 24, 2018
- Eligibility for Conditional Early Approval “Will Not Be Restricted to Orphan Drugs”: MHLW
January 24, 2018
- Japan’s 1st Herceptin Biosimilar Likely to Be OK’ed by March for Gastric Cancer
January 23, 2018
- Shionogi’s Sakigake-Designated Flu Med Up for MHLW Panel Review on Feb. 2, Early Listing Possible?
January 23, 2018
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