Drug receives orphan designation for MM

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Bone marrow aspirate
showing MM
The US Food and Drug Administration (FDA) has granted orphan designation to PT-112 as a treatment for multiple myeloma (MM). PT-112 is a small-molecule conjugate of pyrophosphate and platinum that promotes apoptosis with damage-associated molecular patterns, leading to downstream T-cell recruitment in the tumor microenvironment. PT-112 is... [Read Article]
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Factor IX product launched in US

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Rebinyn vials
Photo from Novo Nordisk
The recombinant, GlycoPEGylated coagulation factor IX product Rebinyn® is now available in the US for the treatment of patients with hemophilia B. Last May, Rebinyn was approved by the US Food and Drug Administration for on-demand treatment and control of bleeding episodes as well as perioperative management... [Read Article]
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Azacitidine now available in China

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Vials of drug
Photo by Bill Branson
Azacitidine for injection (Vidaza®) is now available in China. The nucleoside metabolic inhibitor was approved in China to treat patients with intermediate-2/high-risk myelodysplastic syndromes (MDS), acute myeloid leukemia (AML) with 20% to 30% bone marrow blasts, and chronic myelomonocytic leukemia (CMML). Azacitidine for injection is marketed in... [Read Article]
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FDA approves ready-to-use bivalirudin

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Thrombus
Image by Kevin MacKenzie
The US Food and Drug Administration (FDA) has approved a ready-to-use formulation of bivalirudin for use as an anticoagulant in patients undergoing percutaneous coronary intervention. Baxter International Inc. expects to launch this frozen, premixed formulation of bivalirudin—Bivalirudin in 0.9% Sodium Chloride Injection—in the US early this year. The... [Read Article]
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EC authorizes brentuximab vedotin for CTCL

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Brentuximab vedotin
Photo from Business Wire
The European Commission (EC) has extended the conditional marketing authorization for brentuximab vedotin (Adcetris®). The drug is now approved for use in adults with CD30-positive cutaneous T-cell lymphoma (CTCL) who have received at least 1 prior systemic therapy. Brentuximab vedotin can be marketed for this indication in the... [Read Article]
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EC approves product to treat hemophilia A

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Vial of Adynovate, the US
version of Adynovi
Photo courtesy of Baxalta
The European Commission (EC) has granted marketing authorization for rurioctocog alfa pegol (Adynovi). Rurioctocog alfa pegol (formerly BAX 855) is a pegylated, full-length, recombinant factor VIII product built on a previously licensed recombinant factor VIII product (Advate). Rurioctocog alfa pegol is now... [Read Article]
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Drug’s label updated to include risk of allergic reactions

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IV and oral Varubi (rolapitant)
Photo from Tesaro
The US Food and Drug Administration (FDA) and Tesaro, Inc., have updated the prescribing information for Varubi® (rolapitant) injectable emulsion to include a new warning about the risk of allergic reactions. Varubi injectable emulsion is a substance P/neurokinin receptor antagonist approved to prevent delayed nausea and... [Read Article]
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