Drug Watch (Product News)

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Hepatic Failure and Hepatorenal Syndrome with Tarceva

OSI Pharmaceuticals and Genentech are alerting healthcare professionals about hepatic failure and hepatorenal syndrome with the use of Tarceva (erlotinib), particularly in patient with baseline hepatic impairment. Tarceva is approved to treat certain patients with lung or pancreatic cancer.

Rare Disease of Interest: 
Hepatorenal Syndrome, or HRS Type I
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FDA Licenses New Hemophilia Treatment

FDA recently licensed a new treatment for hemophilia A called Xyntha. Xyntha, which is made by Wyeth Pharmaceuticals, is a genetically engineered version of factor VIII, a protein essential for blood clotting that is decreased or absent in patients with hemophilia A.

Xyntha is produced without additives from human or animal material. This provides hemophilia A patients with an additional treatment option that can further minimize the risk of infection from the product.

FDA Patient Safety News: May 2008

Rare Disease of Interest: 
Hemophilia (A & B)
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Shire Announces FDA Approval of VPRIV for Gaucher Disease

The global specialty biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for VPRIV, a human cell line derived enzyme replacement therapy (ERT) for the long-term treatment of Type 1 Gaucher disease in pediatric and adult patients. The FDA designated VPRIV for Priority Review and granted marketing approval in just 6 months. VPRIV offers patients and their physicians a new treatment option at a critical time, as the supply of the previously approved ERT for Gaucher disease is uncertain and remains disrupted.

Rare Disease of Interest: 
Enzyme Replacement Therapy
Hunter Syndrome
Type 1 Gaucher Disease
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