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
Zolgensma’s Japan Launch Delayed into 2020 as Sakigake Review Drags On, MHLW Still Eager to Make Decision by Year-End
The Japan debut of Novartis’ spinal muscular atrophy (SMA) gene therapy Zolgensma is expected to be delayed into next year as regulators have yet to wrap up its review nearly a year after its filing despite its sakigake tag. Although…
To read the full story
Related Article
- Novartis’ Flawed and Delayed Inquiry Responses in Zolgensma Review “Extremely Unusual”: PMDA Report
April 16, 2020
- Zolgensma Up for Japan Advisory Panel Meeting on Feb. 26, Listing Expected as Early as May
February 17, 2020
- Zolgensma Not on Roster for Nov. 13 MHLW Panel Review
November 7, 2019
- Novartis’ SMA Gene Therapy Filed in Japan on Nov. 1 after US, EU; What Will Happen to Sakigake Status?
November 13, 2018
- AVXS-101 Is Game Changer for SMA Treatment: Novartis Neuroscience Chief
October 24, 2018
BUSINESS
- 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
- Japan Pharma Market Projected to Cross 12 Trillion Yen in FY2029: IQVIA
November 29, 2024
- Leqembi Now Available in South Korea: Eisai
November 29, 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…