Amgen Announces Positive Top-line Results From Phase 3 DAHLIA Study Of ABP 959

RTTNews | 981 dagar sedan
Stocktwits
Amgen Announces Positive Top-line Results From Phase 3 DAHLIA Study Of ABP 959

(RTTNews) - Amgen, Inc. (AMGN) announced Tuesday positive top-line results from the DAHLIA study, a randomized, double-blind, active-controlled, two-period crossover Phase 3 study evaluating the efficacy and safety of ABP 959, a biosimilar candidate to SOLIRIS (eculizumab), compared with SOLIRIS in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

The study met its primary endpoints, demonstrating no clinically meaningful differences between ABP 959 and SOLIRIS based on the control of intravascular hemolysis as measured by lactate dehydrogenase (LDH) at week 27 for the parallel comparison, and the time-adjusted area under the effect curve (AUEC) of LDH from week 13 to week 27, from week 39 to week 53, and from week 65 to week 79 for the crossover comparison. The safety and immunogenicity profile of ABP 959 was comparable to SOLIRIS.

ABP 959 is being developed as a biosimilar candidate to SOLIRIS, for the treatment of PNH and other indications. ABP 959 has the same pharmaceutical form, dosage strength, route of administration and dosing regimen as licensed eculizumab in the United States (U.S.) and European Union (EU).

Taggar: AMGN
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Amgen's Bkemv Approved As First Interchangeable Biosimilar To Soliris

Amgen's Bkemv Approved As First Interchangeable Biosimilar To Soliris

The U.S. Food and Drug Administration has approved Amgen Inc.'s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab), developed by British drug major AstraZeneca's Rare Disease unit Alexion Pharmaceuticals, to treat certain rare diseases. Soliris is a medicine used to treat adults and children with paroxysmal nocturnal haemoglobinuria or PNH...
RTTNews | 335 dagar sedan
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 | 35 minuter sedan
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 | 45 minuter sedan
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 20minuter sedan
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 23minuter sedan
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