While Japan has now granted its first emergency approval to Shionogi’s COVID-19 pill Xocova (ensitrelvir), the drug failed to win a unanimous vote by advisory panels, with skepticism lingering over its actual efficacy. To prep for the next emergency, which…
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 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
- KM Biologics to File COVID Jab in Japan Spring 2023: Official
November 29, 2022
- Kyowa Kirin Unit, Grunenthal Seal JV Deal for Established Medicines Biz
November 28, 2022
- Mediator Sees Potential for Turnaround in Nichi-Iko’s Restructuring Plan
November 28, 2022
- PeptiDream to Codevelop Lilly's Alzheimer’s Diagnostic Tauvid in Japan
November 25, 2022
- Opdivo Secures Top-Selling Title, Veklury Runner Up in July-September: IQVIA
November 25, 2022
As the year 2022 draws to a close, what are managers thinking at the world’s leading pharmaceutical companies and medical device companies? We surveyed 86 managers at these companies to find out what’s on their minds.For many managers, a common…
A Japanese reimbursement policy panel on November 16 saw a continued scuffle between members representing healthcare providers and payers over…
Deloitte Tohmatsu Consulting proposed three drug pricing schemes designed to trigger the consolidation of generic makers on October 27, offering…
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…