Astellas Pharma Gets Positive CHMP Opinion For XTANDI In Early Prostate Cancer Treatment Setting

RTTNews | 510 일 전
Astellas Pharma Gets Positive CHMP Opinion For XTANDI In Early Prostate Cancer Treatment Setting

(RTTNews) - Astellas Pharma Inc. announced Friday the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of XTANDI (enzalutamide) as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy.

The positive CHMP opinion is based on the results from the Phase 3 EMBARK trial.

The positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines in all 27 European Union (EU) member states as well as Iceland, Liechtenstein and Norway.

Astellas is also discussing the EMBARK data with other regulatory authorities to support additional license applications for XTANDI in this indication in 2024 and beyond.

read more
Japan Shares May Tick Lower Again On Friday

Japan Shares May Tick Lower Again On Friday

The Japan stock market on Thursday snapped the six-day winning streak in which it had surged more than 3,000 points or 7.3 percent. The Nikkei 225 now sits just beneath the 42,650-point plateau and it may remain stuck in neutral on Friday.
RTTNews | 24 분 전
Japan GDP Data Due On Friday

Japan GDP Data Due On Friday

Japan will on Friday release preliminary Q2 numbers for gross domestic product, highlighting a busy day for Asia-Pacific economic activity. GDP is expected to rise 0.1 percent on quarter and 0.4 percent on year following the flat quarterly reading and the 0.2 percent contraction in the three months prior. Capex is seen higher by 0.5 percent on quarter, easing from 1.1 percent in Q1.
RTTNews | 1 시간 24 분 전
U.S. Dollar Firms After Strong PPI Data

U.S. Dollar Firms After Strong PPI Data

The U.S. dollar climbed against its major counterparts in the New York session on Thursday, following the release of hotter-than-expected producer inflation report for July.
RTTNews | 1 시간 34 분 전
Swiss Market Ends Modestly Higher After Mild Struggle

Swiss Market Ends Modestly Higher After Mild Struggle

The Switzerland market recovered after a flat start on Thursday, and after staying positive till well past noon, suffered a setback but regained some strength to eventually end the day's session modestly higher.
RTTNews | 6 시간 3 분 전