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…
BUSINESS
Kaketsuken Denies Unauthorized Manufacturing or Cover-up, Blames Ambiguity in Approval Doc
Vaccine and blood product maker Kaketsuken on October 18 denied the health ministry’s claim that it used an unauthorized method to manufacture its Japanese encephalitis vaccine Encevac, contending that the regulator misinterpreted an ambiguous statement in its approval document. Motoharu…
To read the full story
Related Article
- Kaketsuken Wraps Up Blanket Re-Inspection, Says There’s No Quality or Safety Concern
December 6, 2016
- Health Minister Nudges Kaketsuken on Biz Handover to Astellas
October 19, 2016
- MHLW to Consider Additional Penalties for Kaketsuken after Reviewing Its Report: Minister Shiozaki
October 11, 2016
- Kaketsuken Faces Another Penalty over Encephalitis Vaccine Manufacturing
October 5, 2016
BUSINESS
- Lilly Japan Pitching Unique Benefits of Kisunla with AD Drug Now on Market
December 2, 2024
- J&J Makes Debut in Japan Lung Cancer Market with Rybrevant Launch
December 2, 2024
- Takeda Suspends Shipments of MR Vaccine as Quality Issue Drags On
December 2, 2024
- Sumitomo’s iPSC-Derived Retinal Sheet Set to Enter Clinic in US
December 2, 2024
- Alfresa Files ARS’ Epinephrine Nasal Spray in Japan
December 2, 2024
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…