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CSL Vifor Says FDA Grants Partner American Regent Approval For Injectafer To Treat Iron Deficiency
(RTTNews) - Swiss pharma firm CSL Vifor, a subsidiary of Australia's CSL Ltd. (CSL.AX, CSLLY.PK), announced Monday that the U.S. Food and Drug Administration (FDA) has granted its partner American Regent, Inc., a Daiichi Sankyo Group company, approval for Injectafer for the treatment of iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity.
CSL Vifor has granted American Regent an exclusive right to develop, manufacture and market Injectafer in the United States.
The FDA approval was supported by CSL Vifor's randomized placebo-controlled study, CONFIRM-HF (NCT01453608), which evaluated the efficacy and safety of ferric carboxymaltose in adult patients with symptomatic heart failure and iron deficiency.
The treatment over a 1-year period resulted in a significant and sustainable improvement in exercise capacity in this patient population.
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CSL Behring Says HEMGENIX Receives Positive Canada Reimbursement Decision
CSL Behring Canada Inc., a business unit of Australian biotechnology company CSL Ltd. (CSL.AX, CMXHF.PK), announced Tuesday that the Canadian Agency for Drugs and Technologies in Health (CADTH) Canadian Drug Expert Committee (CDEC) recommended public drug plan reimbursement for HEMGENIX (etranacogene dezaparvovec) for the treatment of eligible adults with hemophilia B (congenital factor IX deficiency) who require routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
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New York Manufacturing Index Edges Modestly Lower In May
A report released by the Federal Reserve Bank of New York said regional manufacturing activity continued to decline modestly in the month of May. The New York Fed said its general business conditions index edged down to a negative 9.2 in May from a negative 8.1 in April, with a negative reading indicating contraction. Economists had expected the index to dip to a negative 10.0.
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10 minuter sedan
Philly Fed Index Jumps More Than Expected But Remains Negative In May
Philadelphia-area manufacturing activity remained weak in the month of May, according to a report released by the Federal Reserve Bank of Philadelphia on Thursday. The Philly Fed said its diffusion index for current general activity jumped to a negative 4.0 in May from a negative 26.4 in April, but a negative reading still indicates contraction.
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U.S. Retail Sales Inch Up In Line With Estimates In April
A report released by the Commerce Department on Thursday showed a slight increase by U.S. retail sales in the month of April. The Commerce Department said retail sales crept up by 0.1 percent in April after surging by an upwardly revised 1.7 percent in March. Economists had expected retail sales to inch up by 0.1 percent compared to the 1.4 percent jump originally reported for the previous month.
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1h 20minuter sedan
U.S. Producer Prices Unexpectedly Decrease In April
Producer prices in the U.S. unexpectedly decreased in the month of April, according to a report released by the Labor Department on Thursday. The Labor Department said its producer price index for final demand fell by 0.5 percent in April following a revised unchanged reading in March. Economists had expected producer prices to rise by 0.2 percent.
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Eurozone GDP Expands 0.3% In Q1; Employment Growth Improves
Euro area economic growth accelerated less than estimated in the first quarter and employment logged a faster increase, flash estimate from Eurostat showed on Thursday. Gross domestic product expanded 0.3 percent on a quarterly basis, which was revised down from the 0.4 percent growth estimated on April 30. This followed the fourth quarter's 0.2 percent expansion.
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1h 24minuter sedan
U.S. Weekly Jobless Claims Unchanged From Upwardly Revised Level
The Labor Department released a report on Thursday showing first-time claims for U.S. unemployment benefits came in unchanged in the week ended May 10th The report said initial jobless claims came in at 229,000 last week, unchanged from the previous week's revised level. Economists had expected jobless claims to tick up to 229,000 from the 228,000 originally reported for the previous week.
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1h 32minuter sedan
U.S. Industrial Production Unexpectedly Unchanged In April
With a rebound by utilities output offset by decreases by manufacturing and mining output, the Federal Reserve released a report on Thursday showing industrial production in the U.S. came in unchanged in the month of April.
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2h 9minuter sedan
