For 25 years, Morunda has been interviewing leaders in Japan’s pharmaceutical and medical device industry. Most country managers typically come from a commercial background, rooted in sales and marketing. It’s rare to find country managers who come from finance or…
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REGULATORY
- LDP Study Group on Biologics to Hold 1st Meeting on Nov. 24; Aims to Halt the Rush to Promote Biosimilars
November 11, 2016
- Chuikyo Members Chide Unexplained Withdrawal of Taltz’s Listing Request
November 10, 2016
- MHLW Won’t Require Use of Other Psoriasis Drugs before Taltz
November 10, 2016
- MHLW Plans 50% Price Cut for Opdivo
November 10, 2016
- Chuikyo OKs Taltz, Micatrio for Listing on Nov. 18; Keytruda Takes Pass This Time
November 9, 2016
- LDP Lawmakers Discuss Re-Pricing of Opdivo; Some Say Application of Huge Seller Rule Reasonable
November 9, 2016
- Shiozaki Lauds BIKEN-Mitsubishi Vaccine JV
November 8, 2016
- PMDA Fastest in Granting New Drug Approvals
November 4, 2016
- PMDA Mulls Fee Raise for Drug, Device Reviews
November 4, 2016
- Medical Corporation in Tokyo Ordered to Temporarily Suspend Regenerative Medicine Service: MHLW
November 4, 2016
- MHLW Struggling to Set Date for Chuikyo Subcommittee Discussions on Opdivo
November 2, 2016
- MHLW Panel Backs Ono’s Hyperparathyroidism Drug Etelcalcetide
November 1, 2016
- PMDA Had 71 Individual Interviews in Regulatory Strategy Consultation Services in April-September 2016
November 1, 2016
- Inisync, 4 Other DPP-4 Inhibitors Under PMDA Risk Review
October 31, 2016
- Postponed PAFSC 2nd Committee Meeting Set for November 11
October 31, 2016
- MID-NET Working Group Discusses Access Fee Calculations
October 28, 2016
- Long-Listed Drug Use by Welfare Recipients Should Require Copay: MOF
October 28, 2016
- Panel Negative about Singling Out OTC-Switched Rx for Health Coverage Talks, Calls for Broader Discussions
October 27, 2016
- Shiozaki Does Not Rule Out Price Cut of Over 25% for Opdivo
October 27, 2016
- MHLW Alerts on Risk of Fulminant Type 1 Diabetes for Keytruda
October 25, 2016
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Earlier this month, the Ministry of Finance (MOF) unveiled a long list of social security proposals towards the FY2025 budgeting,…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…
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…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…
A key Japanese reimbursement policy panel on December 16 approved the government-backed plan for the FY2023 “off-year” drug price revision.…
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…