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Drug gets orphan designation for MDS
The drug, CPI-613, targets metabolic changes that are thought to occur in many cancer cells. It has demonstrated activity and tolerability in a...
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New drug stacks up well against warfarin
AMSTERDAM—The oral anticoagulant edoxaban compares favorably with warfarin as treatment for recurrent venous thromboembolism (VTE), according to...
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Plasma product now available in US
A pooled plasma product that was approved by the Food and Drug Administration in January is now available for use in the US.
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FDA approves infection-detecting system
The US Food and Drug Administration (FDA) has approved the first mass spectrometer system for automated identification of bacteria and yeasts that...
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Pixantrone gaining market access in EU
The French National Health Authority’s Transparency Commission has granted market access for the antineoplastic drug pixantrone (Pixuvri).
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Survey suggests docs could improve trial enrollment
Results of a nationwide poll indicate that many Americans believe participation in clinical trials is important. And most of the individuals...
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Fraud, errors were behind delay of apixaban approval, report shows
Medication mistakes, reporting errors, and record changes are what led the US Food and Drug Administration (FDA) to delay approval of the...
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Fusion protein controls surgery-related bleeding in hemophilia B
AMSTERDAM—A recombinant factor IX Fc fusion protein (rFIXFc) can control bleeding among hemophilia B patients undergoing major surgery, according...
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Canada alters blood donor policy for MSM
Canada is lifting the lifetime ban on blood donations from men who have sex with men (MSM). The country’s new policy will allow MSM to donate...
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New antiplatelet drug seems more effective than standard
SAN FRANCISCO—The novel antiplatelet agent cangrelor is more effective than clopidogrel as thromboprophylaxis for patients undergoing coronary...
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FDA again rejects rivaroxaban for ACS
For a second time, the FDA has decided against approving rivaroxaban (Xarelto) to reduce the risk of cardiovascular events in patients with acute...
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Dabigatran noninferior to warfarin for preventing recurrent VTE
New research suggests dabigatran is noninferior to warfarin as extended prophylaxis for recurrent venous thromboembolism (VTE), and warfarin...
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Company suspends enrollment in drug trials
Credit: Esther Dyson After 2 deaths among patients receiving the BCL-2 inhibitor ABT-199, the company developing the drug has suspended...