Discussions by the Ministry of Health, Labor and Welfare’s (MHLW) study group on the generic industry structure are reaching the last lap. Its final report - a draft of which will be presented later this month - is expected to…
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REGULATORY
- MHLW in Final Stages of Study Aimed at Drafting Guidelines on Nucleic Acid Therapeutics; Final Report Due Out FY2016-End
January 28, 2016
- “Huge-Seller” Re-Pricing Created due to Drugs with Huge Financial Impact: Govt
January 27, 2016
- New Basic Guidelines for Hepatitis Measures to Promote Drug Discovery for Hep B
January 27, 2016
- Sakigake Products Added to Scope of Priority Review: MHLW Notification
January 26, 2016
- MHLW Revises GCP Ordinance to Incorporate New Compassionate Use Scheme
January 26, 2016
- Govt Panel Says New Growth Strategy Should Embrace Further Efforts to Fuel Drug Development
January 26, 2016
- PAFSC First Committee to Discuss Add’l Indications for Rituxan, Cymbalta on Feb. 5
January 26, 2016
- Japan Compassionate Use Gets Underway Covering Sakigake-Requested Products, Orphans
January 26, 2016
- MHLW OKs Japan’s First PCSK9 Inhibitor, Other Drugs
January 25, 2016
- Gilead’s 2 Hep C Drugs Likely to Face Some 30% Price Cut under “Huge Seller” Re-Pricing: Jiho Estimate
January 25, 2016
- Sakigake Review System to Shorten Review Time through Greater Efficiency, Not Simplification: Mr Kono of PMDA
January 25, 2016
- PMDA Reviewing Nexium for Risk of Rhabdomyolysis
January 25, 2016
- MHLW Panel on Blood Programs Approves 950,000-Liter Acquisition Target for Raw Plasma in FY2016
January 22, 2016
- Bill Payer Proposes “Penalties through NHI Prices” for Violations of Pharma Law in Wake of Kaketsuken Scandal: Chuikyo
January 22, 2016
- 4 Listed Drugs plus Similar Products Subject to Cost-Effectiveness Review: Chuikyo
January 21, 2016
- Chuikyo OKs New Drug Pricing Rules for FY2016 Reform; Sakigake-Designated Add’l Indications Also Subject to Premiums
January 21, 2016
- MHLW to Designate 617 Products/134 APIs as “Essential Drugs”: Will Receive Uniform, Stable NHI Prices, Exempt from Z2 Rule
January 21, 2016
- “Huge Seller” Re-Pricing to Hit Sovaldi, 3 Other Brands; Hefty 20 APIs Face Regular Market Expansion Re-Pricing
January 21, 2016
- Need of Placebo-Controlled Studies Will Be Decided on Case-by-Case Basis: PMDA Official
January 20, 2016
- Seriousness of Target Diseases, Efficacy Became Key in Sakigake Designation: MHLW Official
January 20, 2016
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The Japanese health ministry on December 22 approved a batch of medicines for additional indications, including Otsuka Pharmaceutical’s atypical antipsychotic Rexulti (brexpiprazole) and Zenyaku Kogyo’s anti-CD20 antibody Rituxan (rituximab).Rexulti is now newly indicated for the treatment of depression and depressive…
Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…
Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…