Japan’s ruling coalition sustained a crushing blow in the Lower House election last month, only managing to win 215 seats,…
BUSINESS
Japan Grants 1st Conditional Approval to Terumo’s HeartSheet
Major Japanese medical device maker Terumo obtained conditional approval for its cell-based heart failure therapy, HeartSheet, the first such approval given in Japan since a new “regenerative medicine” category was created under the revised pharmaceutical affairs law. HeartSheet, autologous skeletal…
To read the full story
Related Article
- Japan Panel Says No to Full Approval of HeartSheet, Clears Breyanzi’s Broader Label
July 22, 2024
- Terumo Debuts Cell-Based Heart Failure Therapy HeartSheet
May 31, 2016
- Drug Pricing Organization to Price JCR’s Cell Therapy Temcell
October 1, 2015
- Terumo Aims at Annual Sales of 1-2 Billion Yen for HeartSheet within 5-10 Years
September 25, 2015
- PAFSC Committee Recommends Approval for 2 Regenerative Medicine Products
September 4, 2015
BUSINESS
- EMA Backs Leqembi after Re-Examination, but for Limited Use
November 15, 2024
- Stella Pharma Ties Up with TLS for Borofalan in US, Europe
November 15, 2024
- MSD Files PAH Treatment Sotatercept in Japan
November 15, 2024
- Keytruda Maintains Top-Selling Title in Japan in July-September: IQVIA
November 14, 2024
- Mitsubishi Chemical Looking for “Best Partners” for Pharma Biz: CEO
November 14, 2024
For over two decades, Morunda has been at the forefront of interviewing and understanding leaders within Japan’s dynamic healthcare industry, particularly in pharmaceuticals and medical devices. What sets apart successful country managers in this competitive arena isn’t just their professional…
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…