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

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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).

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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...
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Japanese Market Notably Higher

Japanese Market Notably Higher

Reversing the losses in the previous two sessions, the Japanese market is notably higher on Friday, following the mixed cues from Wall Street overnight. The Nikkei 225 is moving above the 37,250 level, with gains across most sectors led by index heavyweights, exporters and technology stocks.
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Indonesia Stock Market May Spin Its Wheels On Friday

Indonesia Stock Market May Spin Its Wheels On Friday

The Indonesia stock market has moved higher in two straight sessions, gathering more than 70 points or 1 percent along the way. The Jakarta Composite Index now rests just above the 7,165-point plateau, although the rally may stall on Friday.
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Australian Market Modestly Higher

Australian Market Modestly Higher

The Australian stock market is trading modestly higher on Friday after opening in the red, reversing some of the losses in the previous session, following the mixed cues from Wall Street overnight. The benchmark S&P/ASX 200 is moving to near the 8,400 level, with gains in financial and technology stocks partially offset by weakness in mining and energy stocks.
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Hong Kong Shares Expected To Open To The Downside

Hong Kong Shares Expected To Open To The Downside

The Hong Kong stock market on Thursday ended the two-day winning streak in which it had rallied almost 500 points or 2.2 percent. The Hang Seng Index now sits just beneath the 23,550-point plateau and it's tipped to open in the red again on Friday.
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