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…
REGULATORY
Japan Approves Lilly’s Kisunla, Eisai’s ALS Med, Gilead’s Trodelvy, and Lots More
Eli Lilly’s Alzheimer’s therapy Kisunla (donanemab) landed Japanese regulatory approval on September 24 along with scores of other medicines, making it the second anti-amyloid β (Aβ) antibody to fight the memory-robbing disease in Japan, after Leqembi (lecanemab). Kisunla was approved…
To read the full story
Related Article
- Kisunla to Follow Same Rules as Leqembi in Pricing and Post-Launch Review
October 10, 2024
- Kisunla Subject to Prior Pricing Review as It Follows Leqembi’s Footsteps
September 26, 2024
- J&J to Offer Rybrevant for Free until NHI Price Listing
September 26, 2024
- Trodelvy Nears Japan Approval as It Sails through Panel Review
September 13, 2024
- Japan Panel OKs BMS ROS1 Inhibitor, Janssen Bispecific, JN.1-Targeted Nuvaxovid
September 2, 2024
- Japan Panel Clears Amgen’s TED Med, Rexulti for Alzheimer’s Agitation and More
August 28, 2024
- High-Dose Mecobalamin Now in Line to Become Japan’s 1st ALS Med in 9-Plus Years
August 28, 2024
- Takeda’s Fruzaqla in Line for Approval, Broader Labels for Truvada, Keytruda, Prevenar 20 Too
August 5, 2024
- Lilly’s Alzheimer’s Med Donanemab Now in Line for Japan Approval
August 2, 2024
REGULATORY
- PMDA Opens US Office in Washington, D.C.
November 5, 2024
- Pediatric Use of 3 ITP Drugs Near Official Approval in Japan
November 1, 2024
- Govt’s Council Calls for Pushing Drug Innovation, Generic Revamp
October 31, 2024
- BeiGene’s Brukinsa, J&J’s Balversa and More Now in Line for Japan Approval
October 31, 2024
- LDP’s Hashimoto Regrets Election Defeat amid Off-Year Debate
October 30, 2024
Japan introduced a new health coverage scheme for long-listed products (LLPs) on October 1. A survey of generic drug makers…
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…