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

RTTNews | 1004 dias atrás
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).

Etiquetas: AMGN
read more
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 | 358 dias atrás
European Stocks Closed Weak On Trump's Fresh Tariff Threat

European Stocks Closed Weak On Trump's Fresh Tariff Threat

European stocks closed on a weak note on Friday despite staging a fairly strong recovery past mid afternoon. After staying modestly higher till noon, the major European markets tumbled after U.S. President Donald Trump threatened to impose 50% tariffs on imports from the European Union from June 1st.
RTTNews | 4 minutos atrás
TSX Recovers After Early Setback; Materials Stocks Move Higher

TSX Recovers After Early Setback; Materials Stocks Move Higher

After a weak start and a subsequent drop to lower levels, the Canadian market recovered well and is down just marginally a little past noon on Friday. The early setback was due to U.S. President Donald Trump's threat that 50% tariffs will be imposed on imports from the European Union beginning June 1st.
RTTNews | 1 h 12 min atrás
U.S. New Home Sales Spike From Downwardly Revised Level In April

U.S. New Home Sales Spike From Downwardly Revised Level In April

The Commerce Department released a report on Friday showing new home sales in the U.S. in the month of April spiked compared to a significantly downwardly revised level in March. The report said new home sales soared by 10.9 percent to an annual rate of 743,000 in April after jumping by 2.6 percent to a downwardly revised rate of 670,000 in March.
RTTNews | 2 h 45 min atrás
Germany Logs Stronger Growth On Tariff Threats

Germany Logs Stronger Growth On Tariff Threats

The German economy grew at a stronger-than-estimated pace in the first quarter as higher tariff threats by the U.S. administration led to the frontloading of orders for the country's goods, lifting exports and industrial production. Gross domestic product grew 0.4 percent, which was double the initial estimate of 0.2 percent, a detailed report from Destatis revealed on Friday.
RTTNews | 3 h 52 min atrás