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

RTTNews | 510 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 | 692 วันที่ผ่านมา
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 | 25 นาทีที่ผ่านมา
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 | 34 นาทีที่ผ่านมา
Canadian Market Remains In Negative Territory After Weak Start

Canadian Market Remains In Negative Territory After Weak Start

The Canadian market, which opened on a weak note Thursday morning, continues to languish in negative territory well past noon, weighed down by losses in technology and industrials sectors.
RTTNews | 4 ชม. 39 นาทีที่ผ่านมา
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 | 5 ชม. 3 นาทีที่ผ่านมา
Major European Markets Close On Positive Note

Major European Markets Close On Positive Note

Amid expectations of a rate cut from the Federal Reserve in September, and hopes the meeting between the Presidents of the U.S. and Russia will help end the war in Ukraine, the major European markets closed on a positive note on Thursday, although the U.K. market underperformed other major markets in the region.
RTTNews | 5 ชม. 19 นาทีที่ผ่านมา
U.S. Producer Price Growth Far Exceeds Estimates In July

U.S. Producer Price Growth Far Exceeds Estimates In July

Producer prices in the U.S. increased by much more than expected in the month of July, the Labor Department revealed in a report released on Thursday. The Labor Department said its producer price index for final demand shot up by 0.9 percent in July after coming in unchanged in June. Economists had expected producer prices to rise by 0.2 percent.
RTTNews | 7 ชม. 47 นาทีที่ผ่านมา