CSL Vifor Says FDA Grants Partner American Regent Approval For Injectafer To Treat Iron Deficiency

RTTNews | 707 days ago
Stocktwits
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.

Tags: CMXHF.PK CSL.AX
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CSL Behring Says HEMGENIX Receives Positive Canada Reimbursement Decision

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.
RTTNews | 300 days ago
European Economic News Preview: UK Unemployment Data Due

European Economic News Preview: UK Unemployment Data Due

Labor market statistics from the UK and economic sentiment from Germany are the top economic news due on Tuesday. At 2.00 am ET, the Office for National Statistics is scheduled to issue UK unemployment and wage data for the first quarter. The jobless rate is forecast to rise to 4.5 percent from 4.4 percent in the preceding period.
RTTNews | 12 minutes ago
Australian Market Trims Early Gains In Mid-market

Australian Market Trims Early Gains In Mid-market

The Australian stock market is trimming its early gains in mid-market trading on Tuesday, but extending the gains in the previous four sessions, following the broadly positive cues from Wall Street overnight. The benchmark S&P/ASX 200 is moving up to near the 8,300 level, with gains across most sectors led by technology, iron ore miners and energy stocks. Gold stocks were the only weak spot.
RTTNews | 2h 1min ago
Asian Markets Track Wall Street Higher

Asian Markets Track Wall Street Higher

Asian stock markets are trading mostly higher on Tuesday, following the broadly positive cues from Wall Street overnight, amid easing fears of a prolonged trade global war after news that the US and China have agreed to drastically reduce the massive tariffs on each other's goods by 115 percent while retaining an additional 10 percent tariff. Asian markets closed mostly higher on Monday.
RTTNews | 2h 29min ago
Additional Support Expected For Thai Stock Market

Additional Support Expected For Thai Stock Market

Ahead of Monday's holiday for Wesak Day, the Thai stock market had alternated between positive and negative finishes through the previous four trading days since the end of the five-day winning streak in which it had advanced more than 50 points or 4.3 percent. The Stock Exchange of Thailand now sits just above the 1,210-point plateau and it's got a strong lead for Tuesday's trade.
RTTNews | 3h 56min ago
Japanese Market Sharply Higher

Japanese Market Sharply Higher

The Japanese stock market is trading sharply higher on Tuesday, extending the gains in the previous three sessions, following the broadly positive cues from Wall Street overnight, with the Nikkei 225 moving above the 38,300 level, with gains across all sectors led by strong gains in technology and financial stocks.
RTTNews | 4h 0min ago
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