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

RTTNews | 353 วันที่ผ่านมา
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.

แท็ก : ALPMY
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Merck Says Phase 3 KEYNOTE-A39/EV-302 Trial Meets Dual Primary Endpoints

Merck Says Phase 3 KEYNOTE-A39/EV-302 Trial Meets Dual Primary Endpoints

Merck & Co Inc. (MRK), known as MSD outside of the U.S. and Canada, announced Friday positive topline results from the Phase 3 KEYNOTE-A39 trial, which was conducted in collaboration with Seagen Inc. (SGEN) and Astellas Pharma Inc. (ALPMY.PK, ALPMY).
RTTNews | 535 วันที่ผ่านมา
Dollar Tumbles As Trade War Ignites Growth Fears

Dollar Tumbles As Trade War Ignites Growth Fears

The U.S. dollar tumbled against major currencies during the week ended March 7 amidst an extended sell-off on Wall Street triggered by the escalation in the trade war and a weak labor market update.
RTTNews | 4 ชม. 26 นาทีที่ผ่านมา
Bay Street Likely To Open On Weak Note

Bay Street Likely To Open On Weak Note

Canadian shares are likely to open on a negative note Monday morning amid fears of a U.S. recession, and rising concerns about China's growth outlook.
RTTNews | 4 ชม. 50 นาทีที่ผ่านมา
Yen Rises Amid Risk Aversion

Yen Rises Amid Risk Aversion

The Japanese yen strengthened against other major currencies in the European session on Monday, as the investor sentiment fell on lingering tariff worries, the threat of a U.S. recession and signs of deepening deflationary pressures in China.
RTTNews | 6 ชม. 5 นาทีที่ผ่านมา
Yen Rises Against Majors

Yen Rises Against Majors

The Japanese yen strengthened against other major currencies in the European session on Tuesday.
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FTSE 100 Slips After Positive Start, Down Nearly 0.6%

FTSE 100 Slips After Positive Start, Down Nearly 0.6%

After a positive start, U.K. stocks retreated Monday morning, with shares from banking sector recording notable losses. Concerns about the outlook for global economic growth and uncertainty about U.S. trade policy are hurting sentiment.
RTTNews | 7 ชม. 18 นาทีที่ผ่านมา
Sensex, Nifty Give Up Early Gains

Sensex, Nifty Give Up Early Gains

Indian shares ended slightly lower on Monday, failing to hold early gains due to uncertainty surrounding U.S. tariffs and signs of deepening deflationary pressures in China.
RTTNews | 7 ชม. 42 นาทีที่ผ่านมา