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 Label Expansions for Alecensa, Nucala and More
The Japanese health ministry on August 28 approved a batch of medicines for additional indications or dosages, including Chugai Pharmaceutical’s cancer treatment Alecensa (alectinib) and GlaxoSmithKline’s anti-IL-5 antibody Nucala (mepolizumab). Alecensa was awarded approval for its use as a postoperative…
To read the full story
Related Article
- 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
- Gilead Files Truvada for HIV Prevention in Japan
February 29, 2024
- Truvada Clears Preliminary Review for PrEP Use, but Coverage Not Granted
February 6, 2024
- Alecensa Filed for Adjuvant Therapy for ALK-Positive NSCLC: Chugai
December 18, 2023
- Pfizer Japan Files 20-Valent Pneumococcal Jab for Older Adults, High-Risk People
September 14, 2023
- Keytuda Filed in Japan in NSCLC Neoadjuvant/Adjuvant Setting: MSD
September 8, 2023
- Nucala Filed in Japan for Chronic Rhinosinusitis with Nasal Polyps: GSK
September 5, 2023
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…