Japan’s drug pricing panel held its final round of industry hearings on December 10 as it heads toward the FY2026…
BUSINESS
EMA Accepts Astellas’ Hot Flash Drug for Review
Astellas Pharma said on September 30 that the European Medicines Agency (EMA) has accepted for review the drug maker’s application for its fezolinetant for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. If approved, the drug…
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
- FDA Target Date for Hot Flash Med Extended by 3 Months: Astellas
February 21, 2023
- 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
- RaQualia Expands Alliance with HK inno.N, Licenses Japan Rights to Reflux Therapy
December 15, 2025
- Obesity Market Projected at 46.6 Billion Yen by 2040 as GLP-1s Fuel Growth: Fuji Keizai
December 15, 2025
- Roche Diagnostics Taps Ex-Medtronic Japan VP Maeda as New CEO
December 15, 2025
- Chugai to Launch US Partnering Office in January 2026
December 15, 2025
- Scrap “Spillover,” “Special” Rules If G1 Rule Is Applied Early: Chugai CEO
December 15, 2025
Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…
Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…