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

RTTNews | 404 days ago
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
TSX Down Nearly 1% Despite Coming Off Early Lows

TSX Down Nearly 1% Despite Coming Off Early Lows

Despite staging a fairly strong recovery after an early setback, the Canadian market remains firmly down in negative territory a little past noon on Wednesday, with stocks from energy, technology and healthcare sectors reeling under selling pressure. Disappointing Canadian and U.S. GDP data, and Trump administration's policy uncertainty are weighing on sentiment.
RTTNews | 1h 6min ago
German Inflation At 6-Month Low, Core Figure Accelerates First Time In 4 Months

German Inflation At 6-Month Low, Core Figure Accelerates First Time In 4 Months

Germany's consumer price inflation slowed for a second straight month in April to its lowest level in six months as energy prices continued to fall, but the core price growth accelerated for the first time since December as services cost growth increased, which warrants caution from the European Central Bank that is set to reduce interest rates further.
RTTNews | 1h 16min ago
U.S. Pending Home Sales Unexpectedly Spike 6.1% March

U.S. Pending Home Sales Unexpectedly Spike 6.1% March

Partly reflecting a substantial increase in the South, the National Association of Realtors released a report on Wednesday showing an unexpected spike by pending home sales in the U.S. in the month of March. NAR said its pending home sales index surged by 6.1 percent to 76.5 in March after jumping by 2.1 percent to a revised to 72.1 in February.
RTTNews | 2h 51min ago
U.S. Consumer Prices Virtually Unchanged In March, In Line With Estimates

U.S. Consumer Prices Virtually Unchanged In March, In Line With Estimates

A closely watched report released by the Commerce Department on Wednesday showed U.S. consumer prices were virtually unchanged in the month of March. The Commerce Department said its personal consumption expenditures (PCE) price index edged down by less than a tenth of a percent in March after rising by an upwardly revised 0.4 percent in February.
RTTNews | 2h 54min ago