Japan’s ruling coalition sustained a crushing blow in the Lower House election last month, only managing to win 215 seats,…
BUSINESS
FDA Target Date for Hot Flash Med Extended by 3 Months: Astellas
Astellas Pharma said on February 20 that the US FDA has extended its target action date by three months for its priority review of the company’s hot flash drug fezolinetant. The drug is under review for the treatment of moderate…
To read the full story
Related Article
- Astellas’ Hot Flash Drug Bags European Nod
December 12, 2023
- EU Panel Backs Astellas’ Hot Flash Drug
October 17, 2023
- Astellas’ Hot Flash Med Nets Positive PIIIb Results in Europe
June 29, 2023
- Astellas CEO Confident about Veozah Uptake, 500 Billion Yen Sales Potential
May 22, 2023
- FDA Approves Astellas’ Blockbuster Hopeful for Hot Flash Treatment
May 16, 2023
- EMA Accepts Astellas’ Hot Flash Drug for Review
October 3, 2022
- Astellas’ Hot Flash Med Accepted by FDA Review, Gets Short-Cut with Voucher Use
August 19, 2022
- Astellas’ Vasomotor Symptom Med Missed Primary Goal in Asian PIII Study
March 16, 2022
- Astellas’s Hot Flash Drug Fezolinetant Delivers Positive PIII Data
March 8, 2022
- Astellas’ Hot Flash Drug Hits Primary Goals in PIII Studies
February 22, 2021
BUSINESS
- Pfizer Files Migraine Drug Rimegepant in Japan
November 28, 2024
- Dermatologist Hails Bimzelx as New Option for HS: UCB Seminar
November 27, 2024
- Shionogi Chided for Violating Promotion Guidelines with Actair
November 27, 2024
- Eisai, NCNP Tie Up for APOE Genetic Testing Research Sponsored by AMED
November 27, 2024
- Oncolys Seeks Marketing License for Regenerative Medicine in Japan
November 27, 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…