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

RTTNews | 242 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
read more
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 | 424 วันที่ผ่านมา
Canadian Market Recovers Well After Early Setback

Canadian Market Recovers Well After Early Setback

The Canadian market, which slid in early trades Tuesday morning on hot inflation data, and rising geopolitical concerns following an escalation in Russia - Ukraine war, recovered lost ground subsequently with a few frontline stocks finding some solid support at lower levels.
RTTNews | 5 ชม. 16 นาทีที่ผ่านมา
U.S. Housing Starts Tumble 3.1% In October, More Than Expected

U.S. Housing Starts Tumble 3.1% In October, More Than Expected

New residential construction in the U.S. tumbled by more than expected in the month of October, according to a report released by the Commerce Department on Tuesday. The report said housing starts dove by 3.1 percent to an annual rate of 1.311 million in October after slumping by 1.9 percent to a revised rate of 1.353 million in September.
RTTNews | 7 ชม. 51 นาทีที่ผ่านมา
U.S. Housing Starts Tumble More Than Expected In October

U.S. Housing Starts Tumble More Than Expected In October

New residential construction in the U.S. tumbled by more than expected in the month of October, according to a report released by the Commerce Department on Tuesday.
RTTNews | 8 ชม. 50 นาทีที่ผ่านมา
Eurozone Inflation Rises To 2% As Estimated

Eurozone Inflation Rises To 2% As Estimated

Eurozone inflation returned to the 2 percent target in October, final data from Eurostat showed on Tuesday. The harmonized index of consumer prices climbed as initially estimated in October after rising 1.7 percent in September. Core inflation that excludes prices of energy, food, alcohol and tobacco, remained unchanged at 2.7 percent in October.
RTTNews | 9 ชม. 9 นาทีที่ผ่านมา
Euro Slides Against Majors

Euro Slides Against Majors

The euro weakened against other major currencies in the European session on Tuesday, as traders are worried that protectionist policies by President-elected Donald Trump could disrupt the Eurozone's growth potential.
RTTNews | 9 ชม. 39 นาทีที่ผ่านมา